Get documents about "WIC Revisions in the WIC Food Packages Proposed Rule
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Monday,
August 7, 2006
Part II
Department of
Agriculture
Food and Nutrition Service
7 CFR Part 246
Special Supplemental Nutrition Program
for Women, Infants and Children (WIC):
Revisions in the WIC Food Packages;
Proposed Rule
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44784 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
DEPARTMENT OF AGRICULTURE DATES: To be assured of consideration, I. Overview
comments must be postmarked on or This proposed rule would implement
Food and Nutrition Service before November 6, 2006. the first comprehensive revisions to the
ADDRESSES: The Food and Nutrition WIC food packages since 1980. These
7 CFR Part 246
Service invites interested persons to revised food packages were developed
submit comments on this proposed rule. to better reflect current nutrition science
RIN 0584–AD77 Comments may be submitted by any of and dietary recommendations than do
the following methods: current food packages, within the
Special Supplemental Nutrition
Program for Women, Infants and • Mail: Send comments to Patricia N. parameters of current program costs.
Daniels, Director, Supplemental Food The proposal is based on the
Children (WIC): Revisions in the WIC recommendations of the National
Food Packages Programs Division, Food and Nutrition
Service, USDA, 3101 Park Center Drive, Academies’ Institute of Medicine (IOM),
AGENCY: Food and Nutrition Service Room 528, Alexandria, Virginia 22302, which was commissioned by FNS in
(FNS), USDA. (703) 305–2746. September 2003, to independently
• Web site: Go to review the WIC food packages. The IOM
ACTION: Proposed rule. http://www.fns.usda.gov/wic. Follow used current scientific information to
the online instructions for submitting assess the nutrient adequacy of the diets
SUMMARY: This proposed rule would of WIC participants; assess the
comments through the link at the
revise regulations governing the WIC supplemental nutrition needs of the
Supplemental Food Programs Division
food packages to align the WIC food population served by WIC; look at the
Web site.
packages with the 2005 Dietary nutrient contributions of the current
Guidelines for Americans and current • E-mail: Send comments to WICHQ-
packages; propose priority nutrients and
infant feeding practice guidelines of the SFPD@fns.usda.gov. Include ‘‘Docket ID
general nutrition recommendations; and
American Academy of Pediatrics, better Number 0584–AD77, WIC Food
make recommendations for specific
promote and support the establishment Packages Rule,’’ in the subject line of
changes to the WIC food packages. The
of successful long-term breastfeeding, the message.
IOM used various data sources
provide WIC participants with a wider • Federal eRulemaking Portal: Go to including the 2005 Dietary Guidelines
variety of food, provide WIC State http://www.regulations.gov. Follow the for Americans, the Dietary Reference
agencies with greater flexibility in online instructions for submitting Intakes, WIC participant data, food
prescribing food packages to comments. consumption and intake data
accommodate participants with cultural All comments submitted in response (Continuing Survey of Food Intakes by
food preferences, and serve participants to this proposed rule will be included Individuals (CSFII); National Health and
with certain qualifying conditions under in the record and will be made available Nutrition Examination Survey
one food package to facilitate efficient to the public. Please be advised that the (NHANES)) and examined nutrition-
management of medically fragile substance of the comments and the related health risks to identify nutrients
participants. The revisions largely identities of the individuals or entities and food groups to try to increase or
reflect recommendations made by the submitting the comments will be subject decrease in the food packages with the
Institute of Medicine of the National to public disclosure. All written goal of improving the nutrition of WIC
Academies in its Report ‘‘WIC Food submissions will be available for public participants. The review of the WIC
Packages: Time for a Change,’’ with inspection at the address above during food packages was further informed by
certain cost containment and regular business hours (8:30 a.m. to 5 extensive comments made in response
administrative modifications found p.m.) Monday through Friday. FNS may to an Advanced Notice of Proposed
necessary by the Department to ensure also make the comments publicly Rulemaking on revisions to the WIC
cost neutrality. The proposed available by posting a copy of all food packages and by comments
improvements to the WIC food packages comments on the FNS Web site at received by the IOM in public forums
can be made without increasing the http://www.fns.usda.gov/wic. during its review.
projected costs. The proposed rule A regulatory impact analysis has been Compared to current WIC packages,
would revise the maximum monthly prepared for this rule. It follows this the proposal:
allowances and minimum requirements regulation as an Appendix. • Provides greater consistency with
for certain supplemental foods; revise the Dietary Guidelines for Americans.
FOR FURTHER INFORMATION CONTACT:
the substitution rates for certain The proposal adds fruits and vegetables,
Debra Whitford, Chief, Policy and
supplemental foods and allow and whole grains to the packages for the
Program Development Branch,
additional foods as alternatives; first time. The revised packages include
Supplemental Food Programs Division,
redesign WIC food packages to enhance foods from each food group except oils
Food and Nutrition Service, USDA,
breastfeeding promotion and support; and allow variety and choice within the
3101 Park Center Drive, Room 528,
revise age specifications for assignment groups. Reductions are made to the
Alexandria, Virginia 22302, (703) 305–
to infant food packages; add fruits and amounts provided for certain foods in
2746, OR
vegetables for WIC participants 6 the current packages in order to be more
Debbie.Whitford@fns.usda.gov. A copy
months of age and older and eliminate consistent with the amounts of these
of the National Academies’ Institute of
juice from infants food packages; add foods recommended in the 2005 Dietary
Medicine report, ‘‘WIC Food Packages:
whole grains to food packages for Guidelines for Americans and WIC’s
Time for a Change,’’ which provides the
children and women and infant food role as a supplemental nutrition
scientific backdrop for this proposed
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meat for fully breastfed infants 6 program.
rule, is available on the FNS Web site
through 11 months of age; revise the • Supports improved nutrient
at http://www.fns.usda.gov/oane/menu/
purpose, content, and requirements for intakes. The proposed additional foods
Published/WIC/FILES/
the Food Package for the Medically and modified amounts of current foods
Time4AChange(mainrpt).pdf.
Fragile, and address general provisions support overall improvement in nutrient
that apply to all food packages. SUPPLEMENTARY INFORMATION: consumption and reduction in the
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44785
prevalence of inadequate or excessive proposed food package more closely education provided by WIC enables
nutrient intakes. Compared with the mirrors the 2005 Dietary Guidelines for participants to make informed decisions
current food packages, the revised Americans and dietary in choosing foods that, together with the
packages are estimated to provide recommendations for infants and supplemental foods contained in the
greater amounts of nearly all the children under two and is more WIC food packages, can meet their total
nutrients of concern with regard to consistent with the nutrition education dietary needs. The intent is to help
inadequate intake identified by the IOM provided to participants. participants to continue healthful
such as iron, fiber, and vitamin E. The • Provides wide appeal to diverse dietary practices after leaving the
revised food packages for women and populations. The proposed additional Program.
children also provide less saturated fat, foods are the foods most often requested Since the creation of the WIC Program
cholesterol, total fat and sodium than over the years by a variety of in the 1970’s, and the last major revision
the current packages. stakeholders such as the National WIC of the WIC food packages in the early
• Provides greater consistency with Association, WIC participants, WIC 1980’s, much has been learned about the
established dietary recommendations State and local agencies, industry and nutritional needs of Americans,
for infants and children under 2, health professionals, and would provide including WIC’s target population of
including encouragement and support more participant choice and a wider pregnant and postpartum women,
for breastfeeding. The revised infant variety of foods than the current food infants, and preschool aged children. In
food packages improve overall nutrient packages. The increased variety and recent years the ability of the WIC
density compared to current packages choice will provide State agencies Program to address the supplemental
while keeping caloric content the same increased flexibility in prescribing nutritional needs of WIC participants
or slightly lower. The revised packages culturally appropriate food packages. through its food packages and nutrition
change age specification for assignment education has received growing
II. Background
as well as establish three feeding attention. Significant interest in
categories to better address current The WIC food packages provide updating the food packages based on
dietary recommendations of the supplemental foods designed to address new information about the needs of low-
American Academy of Pediatrics (AAP) the nutritional needs of low-income income, culturally diverse women,
and promote breastfeeding. The pregnant, breastfeeding, non- infants, and children has been voiced by
packages for breastfeeding infant-mother breastfeeding postpartum women, WIC Program administrators, the
pairs are revised to provide stronger infants and children up to five years of medical and scientific communities,
incentives for continued breastfeeding, age who are at nutritional risk. WIC food advocacy groups, and Congress.
including providing less formula to packages and nutrition education are
the chief means by which WIC affects A. Advanced Notice of Proposed
partially breastfed infants than current
the dietary quality and habits of Rulemaking (ANPRM)
packages, and providing additional
quantities/types of food for participants. WIC is a unique nutrition On September 15, 2003, FNS
breastfeeding mothers. For older infants, assistance program in that it also serves published an ANPRM at 68 FR 53903
the proposal delays the introduction of as an adjunct to good health care during seeking comments on revisions to the
complementary foods, consistent with critical times of growth and food packages offered through the WIC
AAP, from four to six months of age and development to prevent the occurrence Program. FNS solicited public
modifies formula amounts. Infant foods of health problems and to improve the comments to determine if the WIC food
are added and juice eliminated in the health status of Program participants. packages should be revised to better
packages for older infants in order to WIC was never intended to be a primary improve the nutritional intake, health
promote healthy dietary patterns. source of food, nor of general food and development of participants and, if
• Addresses emerging public health assistance. Rather, WIC food benefits are so, what specific changes should be
nutrition-related issues. The scientifically-based and intended to made to the food packages. In response
prevalences of overweight and obesity address the supplemental nutritional to this ANPRM, the Department
in adults, adolescents, and children needs of a specific population—low received 195 letters. Respondents
have increased dramatically, with direct income pregnant, breastfeeding, non- represented the general public, State
implications for WIC participants. For breastfeeding postpartum women, and local WIC agencies, the National
example, childhood overweight has infants and children up to five years of WIC Association (NWA), State WIC
been linked to adverse health outcomes age who are at nutritional risk. In associations, industry, independent
including elevated blood pressure, addition to WIC, the Department health professionals, vendors, WIC
hyperinsulinemia, glucose intolerance, administers a variety of other participants, and others. Comments
type 2 diabetes, dyslipidemia, and other complementary nutrition assistance received from NWA included two
early risks for chronic disease. The programs that work together to provide published position papers (1, 2) that
addition of fruits and vegetables and the a more complete diet to low-income provided recommendations based on
emphasis on whole grains are consistent persons. Low-income families can, and that organization’s analysis of the needs
with recommendations for food patterns frequently do, receive benefits from of WIC participants.
that may contribute to a health body more than one of these programs. The
weight. Compared to the current food largest of these programs, the Food B. Review of the WIC Food Packages by
packages, the revised food packages Stamp Program, provides general food the Institute of Medicine
provide less saturated fat and assistance intended to increase the food In September 2003, FNS contracted
cholesterol than the current packages for buying power of low-income with the National Academies’ Institute
women and children. In addition, the households. of Medicine (IOM) to independently
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revised food packages are designed to The ability of the WIC food packages review the WIC Food Packages in a 22-
encourage breastfeeding and thus may to reinforce nutrition education month study. FNS charged the IOM
contribute to a reduced risk of messages provided to participants is with reviewing the nutritional needs of
overweight in children. critical to affecting the dietary quality the WIC population, and recommending
• Reinforces the nutrition education and habits of infants, children and changes to the WIC food packages.
messages provided to participants. The mothers served by WIC. The nutrition Recommendations were to be cost-
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44786 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
neutral, efficient for nationwide education, breastfeeding, and chronic developed the following criteria to
distribution and vendor checkout, non- disease prevention, and public guide its work. It also used various data
burdensome to administration, and comments received from FNS’ ANPRM. sources to identify nutrients and food
culturally suitable. FNS asked IOM to Under this contract, IOM selected a groups to try to increase or decrease in
consider the supplemental nature of the Committee of experts in nutrition, the food packages (i.e., priority nutrients
WIC Program, burdens/incentives for health, risk assessment and economics and priority food groups), with the goal
eligible families, the role of WIC food to conduct this study in two phases. of improving the nutrition of WIC
packages in reinforcing nutrition During Phase I, the committee 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 cook-
ing 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 proposing yogurt as an authorized agencies are also reminded that
criteria and its review of the nutritional alternative to milk. § 246.16a(g) authorizes State agencies to
needs of WIC participants to develop The price of yogurt as compared to implement a cost containment system
recommendations for changing the WIC the price of milk would considerably for any WIC food other than infant
food packages. The IOM published these increase the monthly cost of the food formula.
recommendations in a report, ‘‘WIC packages for children and women. Soy D. Stakeholder Comments
Food Packages: Time for a Change’’ beverage and tofu also have higher per
(IOM Report), which was released on unit costs than milk; however, the The comments FNS received from its
April 27, 2005). (3). estimated amount of tofu that would be ANPRM represented a wide range of
purchased by WIC participants is perspectives. A majority of those who
C. Cost Neutrality commented expressed general support
substantially lower than that of yogurt.
Since the WIC Program receives a for foods currently offered, but also
Soy beverage can serve as an alternative
finite amount of funding annually to proposed at least one change. Nearly
for all or part of the fluid milk for adult
serve as many participants as this three-fourths of those responding to
women, making it a more cost-effective
funding allows, it is important that FNS stated that fruits and vegetables
substitute. For fruits and vegetables, the
revisions to the WIC food packages be should be added to the packages. Other
IOM’s intent was to move WIC
cost neutral to protect the program’s comments addressed topics including
participants towards some amount of
ability to serve the greatest number of priority nutrients, design and structure
increased fruit and vegetable
eligible women, infants, and children. of the food package, amount of juice,
The IOM conducted a cost analysis as consumption and, at the same time,
amount of milk, choices of milk
part of its review and believes that its reinforce the role of the WIC food products, alternative sources of calcium,
recommendations to revise the WIC packages in nutrition education. The cereal and grain choices, physical forms
food packages were relatively cost- proposed $2 reduction in the cash-value of legumes (i.e., dried or canned beans
neutral, given data available to the IOM fruit and vegetable voucher fulfills this or peas), peanut butter, eggs, tuna,
at that time. However, based on updated intent while ensuring cost neutrality. alternative sources of protein, infant
data, the Department now estimates that The Department believes that this formula, medical foods regulations, cost,
implementing the IOM’s proposed rule largely sets forth the incentives to breastfeed, flexibility at
recommendations in full would cost scope of the IOM recommendations the State agency level, and more variety
$1.3 billion above the cost-neutral level notwithstanding these necessary and choice at the participant level.
over 5 years. Therefore, the Department modifications. Commenters are Comments may be viewed at http://
has modified two of the IOM’s encouraged to suggest alternative ways www.fns.usda.gov/wic/
recommendations to achieve a cost to achieve cost neutrality within the lawsandregulations/revfoodpkg-
neutral proposal consistent with context of the overall IOM anprm.htm#publiccomments. Similar
statutory requirements. The Department recommendations. State agencies will be themes were addressed in over 70
carefully considered which of the IOM responsible for determining how to fully written and 30 oral public comments
recommendations to modify to achieve implement the proposed provisions submitted directly to the IOM
cost neutrality, basing the decision on 3 within their grants. Options available to committee during its 22-month review
criteria—relative cost, nutritional State agencies include applying of the WIC food packages.
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impact, and overall context of the IOM judicious use of currently authorized
recommendations. To achieve cost caseload management procedures, E. Legislative Requirements
neutrality, the Department is proposing including the participant priority Sections 17(a) and (b)(14) of the Child
a cash-value fruit and vegetable voucher system in accordance with § 246.7(e)(4) Nutrition Act of 1966, as amended,
that is $2 less per month than that of WIC regulations, or by implementing (CNA) (42 U.S.C. 1786(a) and (b)(14))
recommended by the IOM, and is not other cost containment measures. State clearly established the WIC Program as
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44787
‘‘supplemental’’ in nature; that is, the peas, and also allows protein-rich tuna III. Priority Nutrients, Nutrition-
WIC supplemental foods are not fish and carrots that provide beta- Related Health Priorities, and Priority
intended to provide a complete diet but carotene (precursor to vitamin A) and Food Groups Cited by the IOM
are designed to provide nutrients dietary fiber. Report (3)
determined by nutritional research to be The IOM Report cites fundamental
lacking in the diets of the WIC G. New Nutrient Recommendations
changes that have occurred in the major
population. The law also directs the health and nutrition risks faced by
Over the past decade, knowledge of
Secretary in Section 17(f)(11) of the WIC’s target population. The
nutrient requirements has increased
CNA (42 U.S.C. 1786(f)(11)) to assure prevalences of underweight and iron-
that, to the degree possible, the fat, substantially, resulting in a set of new
dietary reference values called the deficiency anemia have decreased. Diets
sugar, and salt content of supplemental have improved in many respects, and
foods is appropriate. Section 203(a)(2) of Dietary Reference Intakes (DRIs).(4–9)
The DRIs replace the 1989 nutrients for which intakes often
Public Law 108–265 amended Section appeared to be low in the 1970s
17(b)(14) of the CNA by revising the Recommended Dietary Allowances
(RDAs) as nutrient reference values for (calcium and vitamins A and C) are less
definition of supplemental foods to problematic, particularly for children.
include foods that promote health as the United States population. Based on
the DRIs, many of the recommendations Despite improved access to health care
indicated by relevant nutrition science,
and health services, the prevalences of
public health concerns, and cultural for nutrient intakes for individuals
overweight and obesity in adults,
eating patterns. (RDAs) have changed substantially since
Early legislation for the WIC Program, adolescents, and children have
the WIC food packages were originally
Public Law 92–433 (1972) through increased dramatically, regardless of
formulated. Although basic concepts of
Public Law 94–105 (1975), specifically WIC participation. In addition, marked
nutrition have not changed, there has demographic changes have occurred,
identified protein, iron, calcium and been a substantial increase in
vitamins A and C as nutrients of with both a dramatic increase in the
knowledge of specific concepts such as number of persons served by WIC and
particular concern for WIC participants. bioavailability, nutrient-nutrient
Public Law 95–627, enacted in a substantial shift in the ethnic
interactions, and the distribution of composition of the WIC population.
November 1976, deleted reference to dietary intake of nutrients across
specific nutrients; however, the Hispanics now make up the largest
subgroups of the population. In addition share of WIC participants.(10)
Department retained high-quality to recommended intakes, the DRIs
protein, iron, calcium, and vitamins A A. Priority Nutrients
include appropriate standards to use in
and C as the targeted nutrients in the
determining whether diets are IOM designated a nutrient as a
WIC Program.
nutritionally adequate without being priority nutrient if the prevalence of
F. Current WIC Food Packages excessive. The DRIs encompass more dietary inadequacy was non-trivial, or
WIC food package requirements aspects of nutrition that did the earlier the mean intake is below the AI, or there
appear in § 246.10 of the WIC Program RDAs, as follows: is a recognized nutrition-related health
regulations. The last major revision of priority (e.g., observable levels of iron
• DRIs consider reduction in the risk
the WIC Food Packages was in 1980 (45 deficiency anemia). The methodology
of chronic disease, as well as the
FR 74854, November 12, 1980). The used to identify nutrients at high risk of
absence of signs of deficiency.
1980 rule established six different inadequacy is described by the IOM in
monthly packages—Food Package I for • For most nutrients, DRIs include ‘‘Dietary Reference Intakes:
infants 0–3 months; Food Package II for both RDA and Estimated Average Applications in Dietary
infants 4–12 months; Food Package III Requirement (EAR) values. Assessment.’’ (11) Based on detailed
for children and women with special • For some nutrients, insufficient analyses,1 the IOM Report cites the
dietary needs; Food Package IV for data were available to set EAR and RDA 1 The IOM analyzed nutrient intake using
children 1–5 years of age; Food Package values. For these nutrients, Adequate nationally representative data for WIC children and
V for pregnant and breastfeeding Intake (AI) values were estimated. for non-breastfed WIC infants. However, the IOM
women; and Food Package VI for found that for breastfed infants 6 through 11
• DRIs include Tolerable Upper
nonbreastfeeding postpartum women. months of age, and for the women’s groups, the
Intake Levels (ULs), which are used in nationally representative data did not provide
The Department created an additional
the evaluation of the risk of adverse adequate sample size of WIC participants for
food package in 1992 (57 FR 56231, meaningful analysis. Consequently, the IOM used
November 27, 1992). This enhanced effects from excess consumption.
data for all infants 6 through 11 months and for all
food package, Food Package VII, was • DRIs specify appropriate ranges of pregnant and lactating women. For non-
designed for breastfeeding women who macronutrient densities, which are breastfeeding postpartum women categorically
eligible for WIC (up to six months postpartum), the
elect not to receive infant formula called Acceptable Macronutrient IOM used data for all women within one year
through WIC for their infants. Distribution Ranges (AMDRs). postpartum. The Department would have preferred
Current WIC supplemental foods • When adequate data are available, to have adequate sample size to limit all of these
include iron-fortified infant formula, analyses to the WIC actual groups, so that the
DRIs provide reference values for food recommendations could be completely tailored to
iron-fortified cereals, vitamin C-rich 100 components other than nutrients. the WIC population. Prior research using data from
percent fruit and/or vegetable juice, the Continuing Survey of Food Intakes by
calcium/protein-rich milk and cheese, Assessing nutrient adequacy involves Individuals indicates that there are statistically
protein/iron-rich eggs, protein-rich determining the extent to which the significant differences in dietary intake between
diets of WIC-income-eligible subgroups low income and higher income adults. For example,
peanut butter or dried beans/peas, and when controlling for a wide variety of independent
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physician-prescribed formula/medical meet nutrient requirements without factors, those adults with incomes below 130
foods for participants with certain being excessive. In its Report, the IOM percent of poverty have statistically lower usual
special dietary needs. The enhanced conducted analyses applying the DRIs mean intakes for food energy and almost all
and the recommended methods to vitamins and minerals, and were less likely to meet
package for breastfeeding women either 70 percent or 100 percent of the RDA. (See
increases allowable amounts of juice, assess the nutrient adequacy of the diets Gleason P., A. Rangarajan and C. Olson. ‘‘Dietary
cheese, peanut butter and dry beans/ of WIC participants. Continued
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44788 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
following nutrients as high priority for concern during reproduction and early source of dietary guidance for children
WIC participants. childhood, food allergies, and selected ages two years and older and widely
• WIC infants under one year of age, environmental risks to the health of accepted dietary guidance from
non-breastfed: No nutrients were women, infants, and children. Several professional groups, such as the
identified with a high risk of concerns were identified by the IOM for American Academy of Pediatrics, for
inadequacy. Priority nutrients related to all WIC subgroups—obesity, poor iron children under two years of age. The
risk of excessive intakes in non- status, and contamination of food with IOM Report cites the following
breastfed infants are zinc, preformed dioxin and methylmercury. The IOM concerns:
vitamin A, and food energy (calories). also determined that low folate intake is 1. Children ages 2 through 4 years and
• Breastfed infants 6 through 11 a concern for all women during their women in the childbearing years:
months: Priority nutrients identified as reproductive years because of its • Overall: Intakes of whole grains,
lacking in the diets of breastfed infants importance in preventing neural tube vegetable subgroups excluding potatoes
six months and older are iron and zinc. defects; insufficient calcium intake for and other starchy vegetables, fruits, milk
• WIC children 1 through 4 years of pregnant and breastfeeding women may and milk products, and meats are all
age: Priority nutrients identified as be associated with potential lead lower than recommended on average;
lacking in the diets of young children toxicity for the fetus and infant; low • Children ages 2 through 4: Intakes
are vitamin E, fiber, and potassium, and intake of vitamin D is a potential tend to be low in whole grains and in
iron. Nutrients that may be excessive in concern for women of reproductive age dark green leafy vegetables, deep yellow
the diets of young children are zinc, because of its importance in bone vegetables, cooked dry beans and peas
preformed vitamin A, sodium, food health; and inadequate zinc intake is a rather than vegetables in general; and
energy (calories), and saturated fat. concern for breastfed infants 6 through
• Pregnant, lactating, and non- • Women: Intakes tend to be low in
11 months of age because human milk
breastfeeding postpartum women: whole grains, dark green leafy
does not provide recommended
Priority nutrients identified as lacking vegetables, deep yellow vegetables,
amounts of zinc for older infants.
are calcium, iron, magnesium, vitamin cooked dry beans and peas, and fruit
C. Priority Food Groups and milk groups.
E, potassium, and fiber. Nutrients with
moderate, but still high, levels of To determine whether specific foods 2. Infants and children younger than
inadequacy are vitamins A, C, and B6, or types of food should receive priority 2 years of age:
and folate. Nutrients with lower levels in the re-design of WIC food packages, Dietary practices of most concern to
of inadequacy are iron, zinc, thiamin, the IOM reviewed information about the IOM include the short duration of
niacin, and protein. Sodium intakes and dietary guidance, amounts of foods breastfeeding, excessive consumption of
saturated fat intakes as a percentage of consumed by groups that potentially are fruit juice, early introduction of solid
food energy intakes are excessive in the eligible for the WIC Program, and the food and cow’s milk, low consumption
diets of pregnant, lactating, and non- amounts of foods in current WIC food of fruits (other than juice) and
breastfeeding postpartum women. packages. The IOM’s assessment gave vegetables, and infrequent exposure to
major consideration to the Dietary new foods.
B. Nutrition-Related Health Priorities Guidelines for Americans (DGA), which Exhibit A in this preamble, from the
In addition to analyses of nutrient form the basis of Federal food and IOM Report,(3) summarizes nutrient and
adequacy, the IOM reviewed nutrition programs (Pub. L. 101–445, food group priorities that form the basis
epidemiological evidence on body U.S. Congress, 1990). To do this, the for the proposed revisions of the WIC
weight status, micronutrients of special IOM used the DGA 2005 (12) as the 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
Participant concern with Nutrients and ingredients
Priority food groups concern with regard to ex-
category regard to inadequate to limit in the diet
cessive intake
intake
Infants, less than 1 y, non- No need identified to in- na ...................................... Decrease intakes of Zinc,
breastfed. crease particular nutri- Vitamin A, preformed,b
ents; maintain iron in- and Food energy.
takes and continue to
provide a balanced set
of essential nutrients.a.
Infants, 6–11.9 mo, Increase intakes of Iron na.
breastfed. and Zinc.
Children, 12–23.9 mo ........ Increase intakes of Iron, Increase intakes of a vari- Decrease intakes of Zinc,
Potassium, Vitamin E, ety of non-starchy vege- Vitamin A, preformed, b
and Fiber. tables. and Food energy.
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Intake and Dietary Attitudes Among Food Stamp low intakes is very similar for the high- and low- an unacceptably high risk of inaccurately
Participants and Other Low-Income Individuals,’’ income groups. For example, among the nine representing the true population mean and
United States Department of Agriculture, Food and vitamins and five minerals studied, both the list distribution. Therefore, for the purpose of
Nutrition Service, Office of Analysis, Nutrition and and order of the six nutrients with the smallest comparing nutrient adequacy and excesses among
Evaluation FSP–00–DI, Project Officer Sharron portion of the population consuming 70% of the a group of nutrients when the WIC sample is
Cristofar, Alexandria, Virginia 2002.) However, the RDA is the same for the low- and high-income limited, use of the all-income sample is the best
pattern of which nutrients more frequently have groups. Estimates based on too small a sample have available alternative.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44789
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]
Nutrients of Nutrients of
Participant concern with Nutrients and ingredients
Priority food groups concern with regard to ex-
category regard to inadequate to limit in the diet
cessive intake
intake
Children, 2–4.9 y ............... Increase intakes of Iron, Increase intakes of whole Decrease intakes of Zinc, Limit intakes of Saturated
Potassium, Vitamin E, grains, and a variety of Sodium, Vitamin A, fat, Cholesterol, and
and Fiber. non-starchy vegetables. preformed,b and Food Added sugars.
energy.
Adolescent and adult Give highest priority to in- Increase intakes of whole Decrease intakes of So-
women of reproductive creasing intakes of Cal- grains, a variety of non- dium, Food energy, and
age. cium, Iron, Magnesium, starchy vegetables, fruit, Total fat.
Potassium, Vitamin E, and fat-reduced milk
and Fiber. products.
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 Ironintakes 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 die-
tary 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 pre-
sumed to apply to all individuals regardless of age.
D. Identifying Foods To Reduce or regarding foods in the current WIC food
Eliminate packages to be deleted or reduced in the
Exhibit B in this preamble reflects the proposed revised food packages.
IOM’s recommendations and rationale
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 The maximum amount provides approximately half the amount pro-
breastfed infants. vided 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 Since the food package for infants of this age provides greater
fed infants ages 6–11.9 mo of age. amounts of nutrients through complementary foods, less formula is
needed.
Juice .............................. Delete juice for infants 4–11.9 mo of age; re- Meet AAP recommendations to delay introduction of juice for infants
duce amount of juice for children 1–4.9 y of until after 6 mo of age; allow no more than 4–6 fl oz/day for infants
age. 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 chil- Amounts provided need not exceed amounts recommended by DGA
dren and adults. 2005.(12)
Cheese .......................... Reduce maximum amount allowed in wom- Meets recommendation from DGA 2005 (12) and recommendation
en’s and children’s packages. 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 E. The IOM’s Recommendations in the by WIC’s target population, the
jlentini on PROD1PC65 with PROPOSAL2
recommendations, including analyses, Context of this Proposed Rule characteristics of the WIC Program, and
can be found in its report ‘‘WIC Food the diversity of its participants. IOM’s
Packages: Time for a Change’’ (3) The IOM Report considered current recommendations are intended to make
available at http://www.fns.usda.gov/ recommendations for nutrient intakes the WIC food packages better meet the
oane/menu/Published/WIC/WIC.htm. and dietary patterns, the major diet- supplemental nutrition needs of
related health problems and risks faced 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 last decade. Despite these gains, WIC women provides the least. Similarly,
guidance and more consistent with participants lag behind the general starting at age six months, the proposed
nutrition education messages that population in progress toward meeting package for fully breastfed infants
promote healthful diets for the WIC the breastfeeding objectives of Healthy includes commercial infant food meats
population. People 2010.(16) to add a source of iron and zinc.
The IOM Report has provided FNS Because early supplementation may
B. The IOM’s Recommendations To contribute to the short duration of
with a sound scientific basis for
Promote and Support Breastfeeding Via breastfeeding, only two infant feeding
proposing a new set of food packages for the WIC Food Packages options were recommended initially
the WIC Program. Except for certain cost
containment and administrative As described in the IOM Report, the after delivery—either full breastfeeding
modifications found necessary by the proposed revised food packages for or full infant formula-feeding. The IOM
Department to ensure cost neutrality, infants and women are designed to recommended this approach because
FNS is largely setting forth IOM’s strengthen WIC’s breastfeeding physiology provides a strong basis for
recommendations in this proposed rule promotion efforts and provide avoiding supplemental formula. The
for public comment. However, FNS is additional incentives to assist mothers amount of milk a breastfeeding woman
aware that these proposed revisions in making the decision to initiate and produces depends directly on how often
represent substantial changes for the continue to breastfeed. Breastfeeding is and how long she nurses. Providing
WIC Program, its participants, and the preferred method of infant feeding supplemental formula to a new
authorized vendors. Implementation because of the nutritional value and breastfeeding mother may interfere with
procedures, staff and vendor training, health benefits of human milk.(15, 16, 17) her milk production and success at
and the nature of the nutrition The IOM’s three-pronged approach to continued breastfeeding.
education provided are likely to better promote and support These proposed food package
influence the effectiveness of the breastfeeding through the WIC food changes, as recommended by the IOM,
proposed revised food packages. packages is proposed. The proposed are intended to strengthen WIC’s efforts
Commenters are encouraged to provide approach focuses on the market value of to promote and support breastfeeding as
the package for the mother/infant pair the optimal infant feeding choice for
input that would assist FNS in assessing
for the first year after birth, addresses WIC mothers.
the training and technical assistance
differences in supplementary nutrition
needs of WIC State agencies and WIC- V. Proposed Revisions to the WIC Food
needs of breastfed and formula fed
authorized vendors in implementing Packages
infants, and considers how to minimize
these proposed changes.
early supplementation with infant A. Use of Terms
IV. Re-Design of WIC Food Packages To formula through continued or increased
For the purposes of discussion, this
Enhance Breastfeeding Promotion and efforts to promote and support the
proposed rule uses the following terms.
Support breastfeeding dyad. WIC food categories refers to WIC
Proposed changes to help support
A. Current Breastfeeding Promotion and formula (infant formula, exempt infant
breastfeeding address packages for the
Support in WIC formula and WIC-eligible medical
infant as well as the mother since both
are eligible to receive a WIC food foods); milk and milk alternatives; eggs;
WIC has historically promoted
package. According to the IOM, the peanut butter; legumes (dried beans and
breastfeeding to all pregnant women as
perceived dollar value, from the peas); infant cereal; breakfast cereal;
the optimal infant feeding choice,
mother’s point of view, of the current canned fish; whole wheat bread or other
unless medically contraindicated.
food packages provided for formula- whole grains; infant fruits and
Current federal WIC regulations
feeding infant-mother pairs is vegetables; infant meat; cheese; juice;
(§§ 246.7(e)(1)(iii), 246.7(g)(1)(iii),
substantially larger than that of the and fruits and vegetables.
246.10(c)(7), and 246.11(c)) contain
Food type refers to specific foods
provisions to encourage women to packages for the fully breastfeeding
within a category, e.g., skim milk and
breastfeed and to provide appropriate pairs, especially during the first six
soy-based beverages are types of food in
nutritional support for breastfeeding months postpartum. The IOM believes
the milk and milk alternatives category.
participants, including: that attractive packages for fully Physical form refers to the way in
• Information provided to WIC breastfeeding mother/infant pairs might which the food is manufactured and/or
mothers choosing to breastfeed through act as an incentive for breastfeeding. packaged, e.g., dried, frozen; fresh;
counseling and breastfeeding The proposed revised food packages powder; liquid concentrate; fluid;
educational materials; increase the value of the contents of the evaporated, canned.
• Follow-up support through peer food packages for the fully breastfeeding
counselors; mother/infant pairs while decreasing B. Revised Food Packages I and II for
• Eligibility to participate in WIC the relative value to mothers of the food Infants
longer than non-breastfeeding mothers; packages for partially breastfeeding As recommended by the IOM, this
• Enhanced food package for mothers pairs and fully formula-feeding pairs. rule proposes the following changes in
who exclusively breastfeed their infants; As described by the IOM, the Food Packages I and II for infants
and differences in the proposed packages for (currently § 246.10(c)(1) and (c)(2)).
• Breast pumps, breast shells or the mother-infant pairs are based on • Revise age specifications for
supplemental nursing systems to help differences in nutritional needs. For assignment to infant food packages;
support the initiation and continuation example, fully breastfeeding women • Establish 3 feeding options within
of breastfeeding. require additional calories per day each infant food package—fully
jlentini on PROD1PC65 with PROPOSAL2
In part as a result of strengthened WIC during the first six months postpartum breastfed, partially breastfed, or fully
breastfeeding policy and program as well as higher levels of most vitamins formula fed;
activities in the early 1990’s, WIC and minerals. Thus, the package for • Revise maximum monthly infant
breastfeeding rates have increased at a fully breastfeeding women provides the formula allowances;
faster rate than in the non-WIC most food energy and nutrients, and the • Add infant food fruits and
population in the United States in the package for fully formula-feeding vegetables in Food Package II;
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44791
• Eliminate juice from both infant 2. Change in Age Specifications for maximum amount of formula for the
food packages; Assignment to Food Packages I and II fully formula fed infant. In such
• Disallow provision of infant As recommended by the IOM, this instances, the infant’s feeding option
formula for breastfed infants during the proposed rule would revise Food would be changed from partially
first month after birth; Package I to serve infants from birth breastfed to fully formula fed and the
• Disallow low iron infant formula; through age 5 months and revise Food mother’s food package adjusted
Package II to serve infants ages 6 months accordingly.
• Allow commercial infant food meat
for fully breastfed infants in Food through 11 months. Currently, the 4. Introduction of Complementary
Package II; and assignment to Food Package II occurs at Foods at 6 Months of Age
• Reassign infants with a qualifying age four months. As recommended by the IOM, the
condition to proposed revised Food 3. Establishment of Infant Feeding proposed Food Package I would provide
Package III—Participants With Options only iron-fortified infant formula for
Qualifying Conditions—and authorize partially breastfed and fully formula fed
a. First Month After Birth. To support
the issuance of exempt infant formulas infants until an infant is six months old.
the successful establishment of As cited by the IOM, this change is
only in Food Package III.
breastfeeding, the proposed rule, as consistent with recent position
The proposed revisions to Food recommended by the IOM, would
Packages I and II for infants, as statements from the American Academy
establish two infant feeding options for of Pediatrics emphasizing that the
recommended by the IOM, are designed the first month after birth, either full
to better promote and support the introduction of complementary feedings
breastfeeding or full formula-feeding. before six months of age only substitutes
establishment of successful long-term That is, formula would not be provided
breastfeeding among women who foods that lack the protective
for fully or partially breastfeeding components of human milk and that
choose that feeding method, address infants during the first month after
differences in nutritional needs of exclusive breastfeeding should be used
birth. If a breastfeeding mother requests as the reference or normative model for
breastfed and formula fed infants, formula during the first month, the
address developmental needs of infants, feeding infants. Six months is the age at
Department would advise WIC staff to which most healthy infants are
bring the infant food packages in line continue to provide breastfeeding
with current infant feeding practice developmentally ready to handle
support for the mother, with special complementary foods. Infants do not
guidelines from the AAP, and serve all attention to the provision of peer
participants with certain medical need complementary foods for
counseling, breast pumps, consultation nutritional reasons at younger ages—
conditions under one food package to with lactation experts, and referrals to
facilitate efficient management of either breastmilk or iron-fortified infant
medical providers when appropriate. formula would entirely meet the
medically fragile participants. Anticipatory guidance for new mothers nutritional needs of most infants.
1. Reassignment of Infants With during the prenatal period would be Providing complementary foods
Qualifying Conditions to Food Package important for the success of this beginning at age six months is
III approach. As is currently the case, the consistent with common guidelines for
breastfeeding mother could ask to have clinical practice in the field of
Medically fragile infants currently the infant assigned to full formula
receive either Food Package I pediatrics.
feeding option at any time and WIC staff
(§ 246.10(c)(1)) for infants 0–3 months of would reassign the infant’s and the 5. Disallowance of Low-Iron Infant
age or Food Package II (§ 246.10(c)(2)) mother’s food package accordingly. Formula in Food Packages I, II and III
for infants 4–12 months of age. The WIC b. Second Month After Birth Through It is well documented that iron-
formulas authorized for issuance to Month Eleven. Beginning the second fortified infant formulas play an
infants in Food Packages I and II month after birth, a third infant feeding essential role in providing iron in the
include infant formula, exempt infant option is proposed—partial diets of non-breastfed infants.
formula and WIC-eligible medical foods. breastfeeding. As recommended by the According to AAP, there are no known
This rule proposes to revise IOM, this rule proposes that, for the medical conditions warranting the use
§ 246.10(c)(1) through (c)(3) of Program purposes of assigning WIC food of a low-iron infant formula during
regulations for Food Packages I, II and packages, a partially breastfed infant be infancy. In addition, the IOM
III in order to develop a restructured defined as an infant who is breastfed but recommends that the WIC Program
Food Package III that would serve all also receives formula from the WIC continue to provide iron-fortified infant
categories of participants, including Program in an amount not to exceed formula to prevent iron-deficiency
infants, who have certain diagnosed approximately half the amount of anemia in infants. This proposed rule
qualifying conditions. The revised title formula allowed for a fully formula fed would revise WIC food package
for this food package would be Food infant. Currently, there is not a food regulations to prohibit the issuance of
Package III—Participants with package for partially breastfed infants. all low-iron infant formulas to any
Qualifying Conditions. The rationale for Instead, breastfeeding infants may infants.
including infants in Food Package III is receive up to the maximum amount of
to consolidate all medically fragile infant formula authorized in Food 6. Proposed Revisions and Maximum
individuals with qualifying conditions Packages I and II. State agencies are Monthly Allowances in Food Package
into one package to facilitate efficient currently encouraged to tailor the I—Infants Less Than 6 Months of Age
management and tracking of the benefits amount of infant formula provided As recommended by the IOM, under
jlentini on PROD1PC65 with PROPOSAL2
and costs of providing supplemental based on the assessed needs of the this proposed rule, Food Package I
foods to these participants. Refer to breastfeeding infant. Under this would provide iron-fortified infant
section V.P. of this preamble, Revisions proposal, breastfeeding mothers who formula only. Infant formula would
to Food Package III and their effect on request more than the amount of continue to be authorized in liquid
Food Packages I and II, for further formula allowed for partially breastfed concentrate, powder, and ready-to-feed
information. infants could receive up to the (RTF) physical forms. However, powder
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44792 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
infant formula would be recommended infant formula since the current d. Maximum Monthly Allowances of
in Food Package I for partially breastfed substitution rate of 8 pounds powder Infant Formula. As recommended by the
infants ages one month through three per 403 fluid ounces liquid concentrate IOM, the maximum monthly allowance
months due to its longer shelf life, less is no longer appropriate and could of infant formula would depend on the
waste and capability to mix the small result in providing excess amounts of feeding option, physical form of infant
amounts needed for the partially formula in some cases. The IOM formula provided (concentrated,
breastfed infant. Powder and RTF recommended rounding to whole cans powder, or ready-to-use), and the age of
physical forms are substitutes or in order to reach recommended amounts the infant, as summarized in Exhibit C
alternatives to liquid concentrate and of infant formula. Therefore, the of this preamble.
may be substituted at amounts that proposed maximum monthly • Fully formula fed infants would
provide the approximate number of allowances of liquid concentrate and receive the equivalent of about 806 fluid
reconstituted fluid ounces as the liquid RTF are evenly divisible by the whole ounces reconstituted infant formula per
concentrate form of the same infant can sizes of infant formula currently month from birth through 3 months of
formula. Currently, in both Food available. However, none of the whole age; thus, Food Package I is unchanged
Packages I and II, infant formula container sizes of powder infant formula for fully formula fed infants from birth
allowances are expressed in terms of commonly issued by State agencies through 3 months of age. Fully formula
fluid ounces of liquid concentrate, would provide the same number of fed infants 4 months through 5 months
pounds of powder, and fluid ounces of reconstituted fluid ounces as the liquid of age would receive the equivalent of
RTF. WIC State agencies have suggested concentrate form of the same product in about 884 fluid ounces of reconstituted
to FNS that maximum monthly formula whole containers. The Department infant formula per month;
allowances for liquid concentrate and recognizes that powder is the most • Juice and infant cereal would no
powder physical forms be expressed in economical form for State agencies to longer be provided for infants ages 4
terms of reconstituted fluid ounces. The issue. Therefore, in order to provide a months through 5 months. Compared
Infant Formula Act of 1980 and its nutritional benefit amount with the current package, the amount of
amendments standardized the nutrient recommended by the IOM and to infant formula is increased slightly for
content of infant formulas ensuring that provide administrative flexibility for the infants ages 4 months through 5 months
infant formulas distributed in the issuance of infant formula, this proposal to compensate in part for the decrease
United States contain certain minimum would authorize an amount of powder in nutrients and calories that results
levels of calories and nutrients per infant formula that would provide at from the omission of juice and infant
reconstituted fluid ounce. Therefore, the least the maximum monthly allowance cereal;
Department is proposing to express as the reconstituted liquid concentrate • Partially breastfed infants ages 1
maximum monthly allowances of infant form of the same infant formula in the month through 3 months would receive
formula of liquid concentrate and same food package and infant feeding the equivalent of about 364 fluid ounces
powder physical forms in reconstituted option (fully formula fed or partially reconstituted infant formula per month.
fluid ounces according to the mixing breastfed). State agencies would be Powder infant formula is recommended
directions on the container for required to provide at least the number until the partially breastfed infants
preparation for consumption. RTF of fluid ounces as the same reaches four months of age due to its
liquid will continue to be expressed in reconstituted liquid concentrate infant
fluid ounces. longer shelf life and to minimize waste;
formula up to the maximum monthly and
a. Liquid Concentrate Infant Formula.
allowance for reconstituted powder • Partially breastfed infants 4 months
All liquid concentrate infant formula
infant formula. This would ensure that through 5 months of age would receive
currently marketed is packaged in 13
participants receive comparable the equivalent of about 442 fluid ounces
fluid-ounce cans, is designed to be
nutritional benefit no matter which reconstituted infant formula per month.
mixed with an equal quantity of water
physical form of infant formula they Since infant formula is supplemental
(i.e., has a 1:1 dilution ratio) and
receive. The Department recognizes that to breast milk for partially breastfed
provides the standard dilution of 20
participants issued powder infant infants, the maximum allowance of
kilocalories per fluid ounce
formula may receive a slightly higher infant formula for partially breastfed
reconstituted. Thus, 403 fluid ounces of
liquid concentrate formula reconstitutes amount of reconstituted fluid ounces infants is approximately 50 percent of
to 806 fluid ounces. The proposed than the other forms due to the the maximum allowance for fully
maximum monthly formula allowances currently available container sizes and formula fed infants. According to the
are evenly divisible by the 13-fluid- reconstitution rates. IOM, this approach is designed to
ounce cans of liquid concentrate infant c. RTF Infant Formula. Proposed encourage mothers who are using the
formula. § 246.10(e)(1)(iv) lists the reasons that combination feeding method (feeding
b. Powder Infant Formula. The RTF formula may be authorized as a both breast milk and infant formula) to
reconstituted yields for powder substitute for liquid concentrate. The aim for a greater contribution of breast
formulas vary according to types and maximum monthly allowance of RTF milk to the infant’s intake.
brands of products. Powder milk-based formula provides about the same By definition, fully breastfed infants
infant formulas designed for healthy, number of fluid ounces as the would not receive infant formula from
full-term infants have among the highest reconstituted liquid concentrate form of the WIC Program. Instead, they would
yields when compared to soy-based the same infant formula. The proposed receive the benefit of breast milk, which
infant formulas and exempt infant maximum monthly allowances are provides the nutrients they need and a
formulas. This proposed rule would evenly divisible by the 8 and 32-ounce wide array of protective and health-
jlentini on PROD1PC65 with PROPOSAL2
revise the substitution rate for powder whole containers of RTF infant formula. promoting components in a safe form.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44793
EXHIBIT C.—MAXIMUM MONTHLY ALLOWANCES FOR PROPOSED FOOD PACKAGE I FOR INFANTS AGES BIRTH TO 6
MONTHS, BY FEEDING OPTION
Fully breastfed infants Partially breastfed infants Fully formula fed infants
WIC food
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 reconsti- 442 fl. oz. reconsti- 806 fl. oz. reconsti- 884 fl. oz. reconsti-
tuted liquid con- tuted liquid con- tuted liquid con- tuted liquid con-
centrate *. centrate. centrate. centrate.
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 semisolid foods. The infant food meat • Any variety, single ingredient, of
Monthly Allowances in Food Package for fully breastfed infants provides commercial infant food meat with broth
II—Infants 6 Through 11 Months of Age needed iron and zinc in forms with high or with gravy. Texture may range from
As recommended by the IOM, this bioavailability, and the larger quantities pureed through diced.
proposed rule would revise Food of infant food for fully breastfed infants b. Maximum Monthly Allowance of
Package II to include the following may encourage some mothers to Infant Foods (Fruits, Vegetables, and
changes: continue fully breastfeeding. Meats) for Infant 6 through 11 months
• Food Package II would be provided Long-standing WIC policy has not of age:
to infants from 6 through 11 months of authorized infant cereals that included • For fully formula fed infants. 128
age. This package would differ fruit or infant formula ingredients. ounces of fruits and vegetables (e.g., 32
substantially by infant feeding option, However, this restriction was never 4-ounce jars);
as shown in Exhibit D in this preamble. incorporated into regulatory language. • For partially breastfed infants. 128
Infant formula would be decreased for This proposed rule would clarify in WIC ounces of fruits and vegetables (e.g., 32
fully formula fed infants to 624 fluid regulations that infant cereals with the 4-ounce jars);
ounces of reconstituted liquid added ingredients of infant formula,
• For fully breastfed infants. 256
concentrate infant formula per month milk, fruit, or other non-cereal
ounces of fruits and vegetables (e.g., 64
and for partially breastfed infants to 312 ingredients are not authorized based on
4-ounce jars); and
fluid ounces of reconstituted liquid recommendations of the AAP and cost
concerns. The AAP recommends that • For fully breastfed infants. 77.5
concentrate infant formula per month;
• Infant foods would be added to the single ingredient foods be introduced ounces of infant food meat (31 2.5-
food package to encourage healthy one at a time in an effort to isolate food ounce jars.
dietary patterns; and sensitivities and possibly avert the Fresh banana may replace up to 16
• Juice would be omitted to help development of food intolerances. ounces of infant food fruit at a rate of
make possible the addition of infant Although cereal/fruit combinations may 1 pound of bananas per 8 ounces of
food fruits and vegetables. be appropriate once the risk of food infant food fruit. Fresh bananas for
The amount of infant cereal in the sensitivity has diminished, these infants in Food Package II would be
package would be unchanged. The combination foods are more expensive issued via the standard food instrument
proposed decrease in the maximum than regular infant cereal. In reference system.
allowance of infant formula is to cereal/formula combinations, since As cited by the IOM Report, the
consistent with meeting nutritional infant formula is already provided in rationale for providing a greater quantity
requirements. The amount of infant the food packages, it is not necessary to of infant food fruits and vegetables in
formula proposed for partially breastfed provide additional infant formula in the package for fully breastfed infants is
infants reflects and encourages a greater combination with infant cereal. In to provide added nutritional value to
contribution of breast milk to the addition, authorized infant cereals must improve the parity with other infant
infant’s diet. Decreasing the maximum continue to contain a minimum of 45 packages, to provide sufficient fruits
amount of infant formula and omitting milligrams of iron per 100 grams of dry and vegetables to mix with infant food
juice makes possible needed cereal. meats to increase the palatability of
enhancements. For example, the a. Authorized Infant Foods. strained meats for older infants, and to
addition of infant food fruits and • Any variety of commercial infant encourage prolonged breastfeeding by
vegetables in the second six months of food (fruit or vegetable) without added adding to the convenience and
infancy introduces infants to a variety of sugars, starches, or salt (i.e., sodium). monetary value of the food packages of
nutritious foods at an age when almost Texture may range from strained the fully breastfeeding mother/infant
all infants are developmentally ready for through diced; and pair.
EXHIBIT D.—MAXIMUM MONTHLY ALLOWANCES FOR PROPOSED FOOD PACKAGE II FOR INFANTS AGES 6 MONTHS TO 1
YEAR, BY FEEDING OPTION
Partially breastfed Fully formula fed
Fully breastfed infants infants infants
jlentini on PROD1PC65 with PROPOSAL2
WIC Formula
Infant Formula ........................ ....................................................... 312 fluid ounces of reconstituted 624 fluid ounces of reconstituted
liquid concentrate formula. liquid concentrate formula.
WIC Food
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44794 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
EXHIBIT D.—MAXIMUM MONTHLY ALLOWANCES FOR PROPOSED FOOD PACKAGE II FOR INFANTS AGES 6 MONTHS TO 1
YEAR, BY FEEDING OPTION—Continued
Partially breastfed Fully formula fed
Fully breastfed infants infants infants
Infant food (Fruits and Vege- 256 ounces of infant food fruits 128 ounces of infant food fruits 128 of ounces infant food fruits
tables). and vegetables. and vegetables. and vegetables.
Infant food (Cereal) ................ 24 ounces of iron-fortified infant 24 ounces of iron-fortified infant 24 ounces of iron-fortified infant
cereal. cereal. cereal.
Infant food (Meat) .................. 77.5 ounces of infant food meat.
c. Rounding Up of Infant Foods. package category and infant feeding issued infant formula in amounts
• Infant Formula option. This proposal would require provided by Food Package IB–FF from
Public Law 108–265, the Child State agencies to issue at least the FNB four through five months of age, and
Nutrition and WIC Reauthorization Act but not more than the maximum issued infant formula in amounts
of 2004, enacted on June 30, 2004, monthly allowance for the food package provided by Food Package II–FF from 6
contains a provision that allows a State category and infant feeding option. This through eleven months of age. The
agency to round up to the next whole proposal would require State agencies timeframe or the total number of months
can of infant formula to allow all that use the rounding up option to issue that the participant will receive each
participants to receive the full- infant formula in whole containers of food package is shown in Exhibit E.
authorized nutritional benefit specified the same size for administrative ease
by regulation. This provision only and to use the methodology described
applies to infant formula (not exempt EXHIBIT E.—FOOD PACKAGE
herein to calculate the number of cans TIMEFRAME
infant formula or WIC-eligible medical of infant formula for issuance to
foods) issued as a result from a
participants. Food package Maximum time frame
solicitation bid on or after October 1,
2004. This proposal reflects this This proposal would require
calculating and dispersing the infant I A–FF ....................... 4 months.
authority by calculating and dispersing
formula over the timeframe of the food I B–FF ....................... 2 months.
the infant formula over the timeframe of
package category and infant feeding II–FF .......................... 6 months.
the food package category and infant
feeding option (fully formula fed or option (fully formula fed or partially
partially breastfed). This proposal breastfed). For example, a fully formula Exhibit F describes the methodology
would identify the full nutritional fed infant who participates in WIC from that State agencies must use to calculate
benefit (FNB) provided by infant birth through eleven months of age the amount of infant formula dispersed
formula as the maximum monthly would be issued infant formula in over the timeframe of the food package
allowance of reconstituted fluid ounces amounts provided by Food Package IA– category and infant feeding option,
of liquid concentrate for the food FF from birth through 3 months of age, 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 on container size and the reconstitution Using Enfamil Lipil as the example, the
infant participant born January 1, 2006, rate. Currently, Enfamil Lipil infant 35 cans would be dispersed over 4
would receive Food Package IA—FF formula in a 12.9 ounce can months as evenly as possible, such as 9
issuance amount rounded over a reconstitutes to about 94 fluid ounces cans the first month, 8 cans the second
4-month timeframe multiplied by the per container, Similac Advance infant month, and 9 cans each for months 3
FNB (806 fluid ounces reconstituted) to formula in a 12.9 ounce can and 4.
equal 3224 fluid ounces reconstituted reconstitutes to about 96 fluid ounces
total amount of infant formula for the per container, and Nestle Good Start Exhibit G shows the number of
4-month timeframe. The total amount, Supreme infant formula in a 12.0 ounce powder infant formula containers that
3224 fluid ounces reconstituted, would can reconstitutes to about 87 fluid would be issued to an infant participant
then be divided by the yield of fluid ounces per container. Therefore, the born January 1, 2006, for the fully
ounces reconstituted provided by the 3224 fluid ounces would be divided by formula fed infant food packages, using
authorized container to determine the either 94, 96 or 87 respectively, for a the rounding up methodology, for
total number of containers needed to rounded up total of 35 12.9 ounce cans Enfamil Lipil, Similac Advance, or
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provide 3224 fluid ounces reconstituted. of Enfamil Lipil, or 34 12.9 ounce cans Nestle Good Start Supreme infant
The reconstituted fluid ounce yield of Similac Advance, or 38 cans of 12 formulas for a 1-year certification
provided by container varies depending ounce cans Nestle Good Start Supreme. timeframe.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44795
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
Mead Johnson’s Ross’ Similac
Enfamil Lipil Advance
Approximate reconstitution amount per container (number of 12.9 (number of 12.9
oz. containers) oz. containers)
94 fl. oz. 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 consistent with the authority allowing methodology proposed to calculate and
This proposed rule would allow State State agencies to round up infant disperse infant formula over the
agencies to round up and disperse formula. Rounding up of infant foods timeframe of the food package category
whole containers of infant foods (infant provides administrative flexibility to and infant feeding option. Exhibit H
cereal, infant fruit and vegetables, and State agencies since container sizes of describes the methodology that State
infant meat) over the timeframe of the infant foods vary and rounding ensures agencies must use to calculate and
food package category and infant that infants would receive the full disperse infant foods over the timeframe
feeding option (fully formula fed, fully nutritional benefit recommended by the of the food package category and infant
breastfed or partially breastfed) to allow IOM. feeding option.
all participants to receive the maximum This proposal would require State
monthly allowance of infant foods as agencies that use the rounding up
specified in regulations. This is option for infant foods to use the same
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 timeframe. The 18 8-ounce containers The Department is seeking comments
infant participant born January 1, 2006, can be divided equally by the 6-month on the proposed methodology to round
would receive Food Package II from July food package timeframe and results in 3 up and disperse infant formula and
through December, for a 6-month total 8-ounce containers of infant cereal infant foods.
timeframe. The infant may receive 24 issued each month. The 9 16-ounce d. Department Soliciting Input on
ounces infant cereal per month, containers must be dispersed across the changes to infant feeding packages. The
multiplied by 6 months, to equal a total food package timeframe as evenly as proposed infant feeding options
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of 144 ounces infant cereal. Currently, possible, for example, two containers represent a dramatic change in infant
authorized infant cereal is packaged in per month issued for three months and food package issuance procedures. The
8- and 16-ounce containers. Therefore, one container per month issued for procedural changes affect not only
either 18 8-ounce containers or 9 16- three months on alternating months (e.g. assignment to one of three feeding
ounce containers of infant cereal would 2, 1, 2, 1, 2, 1) to equal the 9 total options but impact the delivery of other
be provided over the food package containers. nutrition services as well. We are aware
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44796 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
that WIC State agencies will experience D. Overview of Revised Food Packages mothers who both breastfeed and
challenges in staff training, assessment V, VI, and VII for Women formula-feed their infants.
of the mother-infant dyad, programming Currently, there are three food Food Package VII would continue to
of management information systems, packages for women without special be provided to fully breastfeeding
and the provision of participant dietary needs. These are Food Package women whose infants do not receive
nutrition education. Successful infant formula from the WIC Program. In
V for pregnant and breastfeeding
implementation of the infant feeding addition, based on estimates of
women; Food Package VI for
options may require enhanced nutrition increased nutrient and energy needs of
nonbreastfeeding postpartum women;
education, peer counseling, and referral women pregnant with more than one
and Food Package VII for breastfeeding
activities to support the successful fetus, these women, as recommended by
women who do not receive infant
establishment of breastfeeding. the IOM, would now receive Food
formula for their infants from the WIC
Package VII rather than Food Package V.
The Department is soliciting input on Program (currently § 246.10(c)(5)
Women who are fully breastfeeding
the potential impacts of the proposed through (c)(7)). As recommended by the
multiple infants would be prescribed
changes to Food Package I and II, and IOM, this proposed rule would retain
1.5 times the maximum amounts of
any comments or suggestions on these food packages, but as discussed in Food Package VII to cover their higher
alternative options for FNS to consider. section V.B. of this preamble, would needs for energy and nutrients. Women
Specifically, FNS would like comments add for the purposes of assigning a food partially breastfeeding multiple infants
regarding the following: package, a definition of partially would receive also Food Package VII.
breastfeeding. Currently, a woman is
• The three infant feeding options; Further, all breastfeeding women would
certified to be eligible for the Program be prescribed Food Package VII during
• Impact of proposed changes on as a breastfeeding woman if she is
breastfeeding rates; the first month postpartum because
breastfeeding on the average of at least their infants would not be receiving any
• Staff training and building support once a day and meets other WIC infant formula from the WIC Program.
for proposed changes among WIC staff; eligibility criteria. Under this proposed As recommended by the IOM, under
• The expression of monthly rule, a woman would continue to be this proposed rule Food Package VII, for
certified eligible as a breastfeeding fully breastfeeding women, would
maximum amounts of infant formula in
woman if she is breastfeeding on the provide the greatest variety and quantity
reconstituted fluid ounces;
average of at least once a day. However, of food; and Food Package VI for
• The methodology used to round up whether or not she receives a food postpartum women, would provide the
infant formula and infant foods; package and which food package she is least. Compared with the current food
• Participant nutrition education; and assigned would be based on the amount packages, all 3 revised food packages for
• Administrative feasibility. of infant formula she requests and women would provide smaller amounts
receives from WIC for her infant and the of milk products, eggs, and juice; the
C. Overview of Revised Food Package IV age of the infant. same amount of iron-fortified cereal;
for Children Under this proposed rule, Food add a requirement that cereals be whole
Package V would be provided for grain; and would add fruits and
Currently there is one package for pregnant and partially breastfeeding vegetables. Whole grain bread or other
children without special dietary needs, woman (up to 1 year postpartum) whose whole grains would be added to Food
Food Package IV for children ages 1 to infants participate in the WIC Program Packages V and VII. The food packages
5 years (currently § 246.10(c)(4)). This and receive infant formula in amounts for women would no longer authorize
proposed rule would continue to that do not exceed the maximum whole milk, and would allow several
provide Food Package IV to children allowances for the partially-breastfed alternatives to cow’s milk to address
ages 1 through 4 years. However, as infant food packages, as appropriate for calcium needs. Canned light tuna would
recommended by the IOM, only whole the age of the infant. continue to be allowed in Food Package
milk would be authorized for children Food Package VI would continue to be VII; canned salmon and sardines would
age one year (12 through 23 months), provided for non-breastfeeding be authorized as substitutes for light
and only milk with a fat content not to postpartum women (up to 6 months). tuna.
exceed two percent would be authorized Food Package VI would also be Women greater than 6 months
for children 2 years of age and older. provided to partially breastfeeding postpartum whose infants do not meet
Compared with the current package, the postpartum women (up to 6 months) the definition of a partially breastfed
revised food package, as recommended whose infants are receiving more than infant. The IOM recommends that a
by the IOM, would include smaller the maximum allowances for the partially breastfeeding woman who
amounts of milk and juice but would partially breastfed infant food package, requests, after the sixth month
add fruits, vegetables, and whole grains. as appropriate for the age of the infant. postpartum, more than the maximum
Cheese would continue to be allowed as In terms of the variety of foods and amount of formula for a partially
a partial substitute for milk; however, amounts offered, Food Package V for breastfed infant, no longer be certified
the maximum cheese substitution partially breastfeeding women is more for the WIC Program. However, FNS has
would be reduced from current WIC desirable than Food Package VI. Food determined that this approach is
regulations. As recommended by the Package V provides whole wheat bread incongruous with the definition of
IOM, with proper medical or other whole grains, peanut butter in breastfeeding in WIC regulations at
documentation, soy-based beverage and addition to legumes, and more milk and § 246.2—the practice of feeding a
tofu would be authorized as substitutes juice than Food Package VI. Food mother’s breastmilk to her infant(s) on
jlentini on PROD1PC65 with PROPOSAL2
for milk. As cited by the IOM Report, Package VI does not provide whole the average of at least once per day. In
these changes would make the entire wheat bread or other whole grains, and WIC, this definition is used to
food package for children more provides the option of peanut butter or determine Program eligibility, and
consistent with the DGA 2005 (12) and legumes, but not both. The incentive allows all breastfeeding women,
help ensure a more balanced nutrient value of Food Package V may encourage regardless of feeding pattern, to
intake for WIC participants. a higher level of breastfeeding among participate in the WIC Program, be
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44797
counted as a breastfeeding woman, and the inclusion of fruits and vegetables in suggested in DGA 2005 (12) for
receive supplemental foods, the WIC food packages. consumption of starchy vegetables; food
breastfeeding promotion and support, intake data indicating that consumption
1. Authorized Fruits and Vegetables
and referrals to health care. The of starchy vegetables meets or exceeds
definition recognizes that any As recommended by the IOM, this these suggested amounts; and food
breastfeeding, even if only on an average proposed rule would include fresh and intake data showing that white potatoes
of once a day, provides some processed (canned, frozen, and dried) are the most widely used vegetable.
immunological and nutritional benefits fruits and vegetables. Fresh, canned, Although not addressed by IOM, the
that would otherwise not be provided to and frozen fruits and vegetables would Department is proposing further
an infant. be authorized for children and women restrictions on fruits and vegetables; and
As such, rather than adopt IOM’s in Food Packages III through VII. Dried therefore this proposal would also not
recommendation in its entirety, FNS fruits and dried vegetables would be authorize:
proposes to revise the definition for WIC authorized for women in Food Packages • Herbs or spices;
III and V through VII. As recommended • Edible blossoms and flowers, e.g.,
‘‘participation’’ at § 246.2. The
by the IOM, dried fruit and dried squash blossoms (broccoli, cauliflower
definition would now include the
vegetables would not be authorized for and artichokes are allowed);
number of breastfeeding women who • Creamed or sauced vegetables;
receive no supplemental foods or food children in Food Packages III or IV to
reduce the risk of choking. • Vegetable-grain (pasta or rice)
instruments but whose breastfed mixtures;
infant(s) receives supplemental food or As recommended by the IOM, to
improve the consumption of fresh fruits • Fruit-nut mixtures;
food instruments. Counting these • Breaded vegetables;
women, although they are not receiving and vegetables and the appeal of this • Fruits and vegetables for purchase
a food package, is consistent with the option, especially for people of different on salad bars;
current practice of counting the infants cultural backgrounds, this proposed rule • Ornamental and decorative fruits
of exclusively breastfeeding women. would place minimal restrictions on and vegetables such as chili peppers on
Therefore, a partially breastfeeding participant choice of fresh produce. a string, garlic on a string; gourds,
woman who requests, after the sixth Because a fresh produce option might painted pumpkins;
month postpartum, more than the not be practical in some situations, a • Fruit baskets and party vegetable
maximum amount of formula for a processed option and a combined fresh trays;
partially breastfed infant would no and processed option for fruits and • Fruit leathers and fruit roll-ups;
longer receive a food package but would vegetables are also proposed. • Peanuts;
continue to count as a WIC participant As recommended by the IOM, for • Juices (juices are provided as a
and receive other Program benefits children and adults in Food Packages separate WIC food category);
III–VII, different physical forms of fruit • Canned and dried mature legumes
(nutrition education, including
and vegetable offerings are proposed, as (these legumes are provided as a
breastfeeding promotion and support,
follows. separate WIC food category); and
and referrals to health and social • Items such as blueberry muffins and
services). This would serve to meet the a. Fresh fruits and vegetables.
intent of IOM’s recommendations • Any variety of fresh whole or cut other baked goods.
within the context of WIC regulations. fruit without added sugars; and 3. Maximum Monthly Allowances
• Any variety of fresh whole or cut
E. Inclusion of Fruits and Vegetables in vegetable, except white potatoes, The IOM recommended that fruits
Food Packages III through VII without added sugars, fats, or oils. and vegetables be provided at levels of
b. Processed fruits and vegetables $10 per month for women and $8 per
As recommended by the IOM, this (canned, frozen, and dried). month for children. However, as
proposed rule would add a variety of • Any variety of canned fruits, discussed earlier in this preamble, to
fruits and vegetables to Food Packages including applesauce; juice pack or achieve cost neutrality, the Department
III, IV, V, VI, and VII (currently water pack without added sugars, fats, has reduced this recommendation by $2
§ 246.10(c)(3) through (c)(7)). The IOM oils, or salt (i.e., sodium); for both women and children.
Report states that the addition of fruits • Any variety of frozen fruits without Therefore, this proposed rule establishes
and vegetables to WIC food packages is added sugars; the value of fruit and vegetable vouchers
consistent with a major • Any dried fruit or vegetable without at levels of $8 per month for women and
recommendation of the DGA 2005 (12)— added sugars, fats, oils, or salt (i.e., $6 per month for children. The
namely, to increase daily intake of fruits sodium); and Department welcomes comments or
and vegetables. The IOM’s basis for • Any variety of canned or frozen suggestions from State agencies
recommending the addition of fruits and vegetables, except white potatoes regarding cost-neutral options for
vegetables was the substantial body of (orange yams and sweet potatoes are providing vouchers at the IOM-
literature that supports the association allowed), without added sugars, fats, recommended levels.
of fruit and vegetable consumption with oils. a. Fresh produce option. Because few
reduced risk of chronic disease fresh fruits and vegetables are sold in
including stroke and perhaps other 2. Restrictions on Authorized Fruits and uniform weight units with uniform bar
cardiovascular diseases, some cancers, Vegetables codes, and their prices vary
and type 2 diabetes. Evidence also This proposed rule would not considerably across seasons, regions,
suggests that increased fruit and authorize: and stores, they cannot be prescribed in
vegetable consumption may be useful in • White potatoes (orange yams and quantity terms and still control the
jlentini on PROD1PC65 with PROPOSAL2
programs to promote and sustain loss of sweet potatoes are allowed); overall cost of the WIC food packages.
body weight in overweight individuals. • Catsup or other condiments; Therefore, this proposal would include
The IOM and FNS received many public • Pickled vegetables and olives; or cash-value food instruments at the level
comments from health professionals, • Soups. of $8 per month for women and $6 per
consumers, WIC Program staff, WIC IOM’s recommended restriction on month for children for fresh fruits and
participants, and others, advocating for white potatoes is based on the amounts vegetables.
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44798 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
Cash-value food instruments will be authorized by the State agency, prohibitively expensive given additional
set at $6 for children and $8 for women § 246.12(g)(3)(i) would be revised to processing costs that may be applied to
in the year in which the proposed food require that vendors authorized by the each transaction, depending on a State’s
package revisions take effect. FNS will State agency carry a minimum of two benefit processing arrangement. The
adjust the maximum value of the varieties each of fruits and vegetables, in cost and implications of these changes
vouchers in whole dollar increments to any combination of fresh and processed. in the existing WIC benefit delivery
reflect the sum of annual, un-rounded However, it is the Department’s system is an area that must be carefully
increases in inflation using the Bureau expectation that more than two varieties considered.
of Labor Statistics’ Consumer Price each of fruits and vegetables be The fruit and vegetable benefit may
Index for Fresh Fruits and Vegetables. In authorized by State agencies. The lend itself to electronic benefit delivery
the fiscal year in which the whole dollar Department welcomes comments or in line with current trends in
increment accrues, the Department suggestions on ways to provide the commercial retail transaction processing
would have the option to increase the widest variety of choice without and consistent with the FNS 5–Year
value of the fruit and vegetable vouchers introducing undue program complexity Plan for Electronic Benefit Transfer
by the whole dollar increment. If the or administrative burden. (EBT). While the majority of State WIC
Department elects this option, it would agencies deliver benefits via paper
4. Implementation of Fruit and checks or vouchers, 5 States are testing
request the funding necessary for the
Vegetable Options the feasibility of EBT and an additional
additional program costs.
The recommendation to use cash- Under this proposed rule, State State has adopted EBT statewide. These
value food instruments for fresh fruits agencies would be encouraged to issue pilots are testing and evaluating the
and vegetables is based on input IOM small denomination, such as $2, cash- feasibility of smartcard and online
received from vendors in public value fruit/vegetable food instruments. technologies. By 2008, FNS hopes to
meetings. The IOM also cited two recent In consideration of the perishable nature identify national model(s) that are
pilot studies in which cash-value of fresh fruits and vegetables, small technically and financially viable for
vouchers for fresh fruits and vegetables denominations are needed so the retail transaction processing for WIC
were provided to WIC participants. (18, participant can obtain small amounts of EBT.
19) The experience from both pilot fresh product at various times during Although it will take a number of
studies, albeit unpublished at the the month, lessening the chance of food years to implement WIC EBT fully in all
present time, suggests that providing spoilage and waste. Any combination of States, the fruit and vegetable benefit
fresh produce to WIC participants using authorized fresh or processed fruit or may provide opportunities for
cash-value vouchers increased the vegetable would be allowed in alternative forms of benefit delivery and
intakes of fruits and vegetables, added quantities with a value up to the amount allow some States to move toward
variety to the diets of WIC participants, of the cash-value food instrument(s). limited electronic benefit processing
and was highly acceptable to WIC The Department welcomes comments or prior to the implementation of EBT for
participants of various ethnic/cultural suggestions on implementation of fresh all WIC purchases. These solutions
backgrounds. fruit and vegetable options. could provide participants with greater
Because of greater participant choice, a. Operational requirements for cash- flexibility in redeeming benefits by
lower cost in many States, and value fruits and vegetables food allowing them to spread their purchases
potentially greater nutrient contribution instruments. Under this proposed rule, out across the month, although some
from fresh produce, State agencies are cash-value food instruments for fruits solutions will likely prove prohibitively
encouraged to offer fresh produce to the and vegetables, as with any WIC food costly in relation to the cash value of the
extent possible. instrument, would be subject to the proposed benefit. FNS will explore the
b. Processed fruit and vegetables requirements in § 246.12—Food range of possibilities for using existing
option. As recommended by the IOM, Delivery Systems. Section 246.12 sets commercial infrastructure to administer
this proposal would allow processed forth design and operational the fruit and vegetable benefit including
(canned, frozen, and dried) fruits and requirements for food delivery systems, WIC EBT smartcard and online
vegetables to be substituted when fresh including vendor authorization, solutions as well as commercial debit
produce is limited and to accommodate accountability, redemption and cards and other technologies.
participant preference. The Department disposition of food instruments. FNS will assess the administrative
proposes to also provide the processed b. Benefit delivery. While most of the burden, technical feasibility, advantages
options via the $8 or $6 cash-value food proposed food package changes could and costs of alternative approaches to
instrument. State agencies would be be administered via existing State delivering the cash value benefit for
authorized to allow the cash-value food benefit delivery systems, the cash-value fruits and vegetables. We recognize that
instrument to be used to obtain any food instruments for the purchase of this benefit will pose challenges and
combination of fresh produce and fruits and vegetables differs from other added costs for the existing paper
processed fruits and vegetables, thereby WIC benefits which provide specified voucher and check system and that
providing maximum flexibility for the quantities of approved food items. The various technical approaches may also
participant. In addition, the ability to fruit and vegetable benefit would be costly and complicated to develop,
combine all fruit and vegetable options require changes to WIC benefit delivery implement, and operate. Since the
on one type of cash-value food systems to accommodate a more open- implications of alternative solutions are
instrument should reduce the ended benefit determined by a cash likely to vary across State WIC agencies
administrative complexity for State value rather than a fixed quantity of a depending on their current participating
agencies and vendors. specific food item. States and vendors vendor characteristics and benefit
jlentini on PROD1PC65 with PROPOSAL2
State agencies are encouraged to allow would have to modify operations and delivery systems, several different
participants the wide variety of choices procedures to issue, transact, and options may be needed to deliver the
within the authorized fresh and process the redemption of a cash value cash value benefit throughout the
processed options. To ensure benefit. The implementation of a cash Program. FNS seeks to minimize the
participant choice among the fresh and value paper voucher or check may prove complexity and cost associated with
processed fruit and vegetables administratively burdensome and administering this benefit and invites
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44799
comments and suggestions on beans may be provided for participants by FDA in its December 9, 2003, Health
alternative approaches and with limited cooking facilities, at the Claim Notification for Whole Grain
considerations. State agency’s discretion. Foods with Moderate Fat Content at
c. Farmers’ markets. The Department http://www.cfsan.fda.gov/~dms/
proposes to allow the State agency to 2. Restrictions on Authorized Types of
flgrain2.html (e.g., must contain a
authorize farmers at farmers’ markets to Canned Beans
minimum of 51% whole grains).
accept the WIC cash-value food This proposed rule would not Proposed allowable substitutions for
instrument for fruits and vegetables. authorize the following forms of canned whole grain bread would include brown
Such markets would have to meet beans: rice, bulgur, oatmeal, and whole-grain
vendor selection criteria specified at • Soups; barley without added sugars, fats, oils,
§ 246.12(g)(3) and would be subject to • With the exception of baked beans, or salt (i.e., sodium). Under this
the vendor agreement requirements those containing added sugars, fats, proposed rule, soft corn or whole wheat
outlined in § 246.12(h)(3). meat or oils as purchased; tortillas without added fats or oils
• Immature varieties of legumes, such would be allowed at the State agency’s
F. Addition of Peanut Butter in Food as those used in canned green peas,
Package V option. Using the minimum
green beans, snap beans, orange beans, requirements and specifications in
As recommended by the IOM, this and wax beans; or proposed § 246.10(e)(12), State agencies
proposed rule would add 18 ounces of • Baked beans with meat, e.g., beans would determine which types and
peanut butter in Food Package V and franks. brands of whole grain products to allow
(currently § 246.10(c)(5)) to improve the on State food lists.
3. Maximum Monthly Substitution Rate
intake of several nutrients, including
iron, folate, Vitamin E, and fiber, in the As recommended the by the IOM, this 2. Maximum Monthly Allowance
diets of pregnant and breastfeeding proposed rule would allow the As recommended by the IOM, this
women. At present, Food Package V substitution of 64 ounces (e.g., four 16- proposed rule would allow 2 pounds of
allows peanut butter only as an ounce cans) of canned mature beans/ whole grain bread or other whole grain
alternative to dry beans and peas. peas for 1 pound of dry mature legumes options for children in Food Packages III
in Food Packages III–VII. and IV; and 1 pound of whole grain
G. Addition of Legumes in Food Package Although not addressed by IOM, the
VI bread or other whole grain options for
Department proposes to allow the women in Food Packages III, V and VII.
As recommended by the IOM, this following additional substitutions in
proposed rule would add 1 pound of Food Package V and VII: J. Milk and Milk Alternatives
dried beans or peas or, as an alternative, • 1 pound dry and 64 ounces of As recommended by the IOM, this
18 ounces of peanut butter, to Food canned beans/peas (and no peanut proposed rule would continue to
Package VI for postpartum women butter) provide milk in food packages for
(currently § 246.10(c)(6)). Currently Or children and women (currently
Food Package VI does not provide • 2 pounds dry or 128 ounces of § 246.10(c)(4) through (c)(7)) as an
legumes of any kind. This addition canned beans/peas (and no peanut important and concentrated source of
would improve the intake of several butter) vitamin D and calcium. This proposed
nutrients, including iron, folate, Or rule would also authorize State agencies
Vitamin E, and fiber, in the diets of • 36 ounces of peanut butter (and no to provide alternatives for milk for
these participants. beans). individuals with lactose maldigestion
I. Addition of Whole Wheat Bread or and for those who avoid milk for
H. Addition of Canned Mature Legumes
Other Whole Grains to Food Packages cultural, religious, or other reasons. To
as an Optional Substitute for Dry
III, IV, V, VII maintain the nutritional content and
Legumes in Food Packages III–VII
cost neutrality of the food packages,
As recommended by the IOM, this As recommended by the IOM, this some alternatives for milk (i.e., calcium-
proposed rule would allow the proposal would add whole wheat bread set tofu and cheese) would be allowed
substitution of canned mature beans/ or other whole grains for children and in limited amounts.
peas for dry mature beans/peas in Food pregnant and breastfeeding women in
Packages III, IV, V, VI and VII (currently Food Packages III, IV, V and VII 1. Nomenclature
§ 246.10(c)(3) through (c)(7)). This (currently § 246.10(c)(3) through (c)(5), This proposed rule uses terminology
substitution, currently authorized for and (c)(7)). This addition responds to for fat-reduced milk products as
homeless persons, would be allowed recommendations of the DGA 2005 (12) required by FDA on labeling for milk
under this proposed rule to increase to consume at least 3 servings per day and milk products (21 CFR 101.62), i.e.,
flexibility and variety in food choices of whole grains to reduce the risk of ‘‘reduced fat’’ has two percent milk fat,
for participants receiving Food Packages coronary heart disease and type 2 ‘‘low fat’’ has one percent milk fat, and
III–VII. diabetes, to help with body weight ‘‘nonfat’’ is skim or fat-free. The term
maintenance, and to increase intake of ‘‘fat-reduced’’ is used in this proposal to
1. Authorized Types of Canned Beans dietary fiber. refer to all varieties with two percent or
This proposed rule would allow any less milk fat.
type of mature dry beans in canned 1. Authorized Whole Grains
form. Examples include but are not This proposed rule would include any 2. Authorized Milks
limited to black beans (‘‘turtle beans’’), bread that conforms to the Food and As long as a milk conforms to the
jlentini on PROD1PC65 with PROPOSAL2
blackeye peas (cowpeas of the blackeye Drug Administration (FDA) standard of FDA standard of identity for milk as
variety, ‘‘cow beans’’), garbanzo beans identity for whole grain bread as defined by 21 CFR Part 131 and meets
(chickpeas), great northern beans, defined by 21 CFR 136.180 or that meets WIC Federal requirements, it is an
kidney beans, lima beans (‘‘butter labeling requirements for making a authorized milk in Food Packages IV, V,
beans’’), pinto beans, navy beans, health claim as a ‘‘whole grain food VI, and VII (currently § 246.10(c)(4)
soybeans, split peas, and lentils. Baked with moderate fat content’’ as defined through (c)(7)). WIC regulations also
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44800 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
require that all authorized milks must that participants issued evaporated milk cases of lactose intolerance or other
be pasteurized and contain at least 400 would receive the same maximum qualifying conditions.
International Units of vitamin D per monthly allowance of milk For women, this proposed rule would
quart (100 IU per cup) and 2000 (reconstituted) as those issued fluid allow cheese or calcium-set tofu to be
International Units of vitamin A per milk . The substitution rate is the same substituted at the rate of 1 pound of
quart (500 IU per cup). for both evaporated whole and cheese per 3 quarts of milk or 1 pound
As recommended by the IOM, under evaporated fat reduced milks. When a of tofu per 1 quart of milk. A maximum
this proposed rule, only whole milk (not combination of different milk physical of 4 quarts of milk can be substituted in
less than 3.25% milk fat) is authorized forms (e.g., fluid plus evaporated) is this manner in Food Packages V and VI;
for children less than 2 years of age in provided, State agencies would have to however, no more than 1 pound of
Food Package IV (currently ensure that the full maximum monthly cheese may be substituted for milk. A
§ 246.10(c)(4)). For children two years of allowances for milk are issued in Food maximum of 6 quarts of milk can be
age and older and women (adolescent Packages IV through VII. substituted in this manner in Food
and adult) in Food Packages IV, V, VI, b. Substitution rates of dry milks. This Package VII; therefore, a maximum of
and VII (currently § 246.10(c)(4) through proposed rule would change how the two pounds of cheese may be
(c)(7)), this proposed rule would substitution rates of dry milks for fluid substituted for milk in Food Package
authorize only milk with no more than milk issued in Food Packages IV, V, VI, VII. State agencies could authorize, with
2% milk fat. and VII (§ 246.10(c)(4) through (c)(7)) medical documentation, amounts of
are expressed. Currently the rates are cheese or calcium-set tofu that exceed
3. Maximum Monthly Milk Allowances
stated as: these substitution maximums, up to the
The current maximum monthly • 1 pound of nonfat or lowfat dry maximum allowance for fluid milk, in
allowances provide about 3.2 cups of milk per 5 quarts of fluid whole milk; cases of lactose intolerance or other
milk a day for children and postpartum or qualifying conditions.
women and about 3.7 cups a day for • 1 pound of dry whole milk per 3 This proposed rule would authorize
pregnant and all breastfeeding women. quarts of fluid whole milk. soy-based beverage to be substituted for
As recommended by the IOM, this The Department proposes to express milk for women in Food Packages V, VI
proposed rule would decrease the the new substitution rates in terms of and VII at the rate of 1 quart of soy-
maximum monthly allowances for milk reconstituted fluid ounce yields of dry based beverage for 1 quart of milk up to
in all food packages. Reducing the milk to make it easier for State agencies the total maximum allowance of milk.
amount of milk provided through WIC to calculate the amount of dry milk to Under this proposed rule, soy-based
is consistent with recommended limits substitute for fluid milk. Although the beverage and tofu are not allowed as
on saturated fat, total fat, and container sizes commonly available for substitutes for milk for children in Food
cholesterol consumption put forth in the dry milks vary in weight, the Package IV without medical
DGA 2005 (12). According to the IOM, reconstituted yields are consistent with documentation. The qualifying
amounts of milk provided by the WIC the substitution ratios of dry milk to conditions may include, but are not
food packages need not exceed amounts fluid milk stated above. For example, a limited to, milk allergy, severe lactose
recommended by DGA 2005 (12). 25.6 oz. box of nonfat dry milk maldigestion, and vegan diets.
Therefore, this proposed rule would reconstitutes to 8 quarts of fluid milk. Requiring medical documentation
reduce the maximum monthly milk This yield is consistent with the 1 ensures that a child’s medical provider
allowances for children 1 through 5 pound of nonfat dry milk per 5 quarts is aware that the child may be at
years and postpartum women from 24 of fluid whole milk WIC substitution nutritional risk when milk is replaced
quarts to 16 quarts, which would ratio. by other foods. State agencies could
provide 2.1 cups per day. This proposed The proposed change will better authorize, with medical documentation,
rule would reduce the maximum accommodate the wide range of soy-based beverages to be substituted for
monthly milk allowances for pregnant container sizes for dry milks now on the milk for children in Food Package IV on
and partially breastfeeding women from market and those that may be added in a quart for quart basis up to the total
28 to 22 quarts of milk (2.9 cups per the future. When a combination of maximum allowance of milk. Tofu may
day); and would reduce the maximum different milk physical forms (e.g., fluid be substituted, with medical
monthly milk allowances for fully plus nonfat dry) is provided, State documentation, for milk for children in
breastfeeding women from 28 quarts to agencies would have to ensure that the Food Package IV at the rate of 1 pound
24 quarts of milk (3.2 cups per day). full maximum monthly milk allowances of tofu per 1 quart of milk up to the total
a. Substitution rates of evaporated are issued in Food Packages IV–VII. maximum allowance of milk.
milk. This proposed rule would change a. Authorized cheese. This proposed
the substitution rate of evaporated milk 4. Authorized Substitutions for Milk rule would clarify that a cheese that is
for fluid milk in Food Packages IV, V, (Cheese, Tofu, Soy-Based Beverage) a blend of authorized WIC cheeses (any
VI, and VII (currently § 246.10(c)(4) As recommended by the IOM to combination of domestically produced,
through (c)(7)). The current substitution provide more flexibility for WIC State made with 100% pasteurized milk,
rate is 13 fluid ounces of evaporated agencies and more variety and choice Monterey Jack, Colby, natural Cheddar,
milk (or 26 fl. oz. reconstituted for WIC participants, this proposed rule Swiss, Brick, Muenster, Provolone, part-
evaporated milk) per quart (or 32 fl. oz.) would allow cheese to be substituted for skim or whole Mozzarella, pasteurized
of fluid milk. This proposal would milk for children at the rate of 1 pound American processed) is a WIC-eligible
increase the substitution rate to 16 fluid of cheese per 3 quarts of milk. No more food. This proposed rule would clarify
ounces of evaporated milk per 32 fluid than 1 pound of cheese may be that cheeses that are labeled low, free,
jlentini on PROD1PC65 with PROPOSAL2
ounces of fluid milk or a 1:2 fluid ounce substituted for milk. State agencies reduced, less, or light in the nutrients
substitution ratio. This is based on a could authorize, with medical sodium, fat, or cholesterol are WIC-
dilution rate of equal parts evaporated documentation, amounts of cheese that eligible.
milk and water (i.e., 12 oz. can exceed this substitution maximum for b. Authorized tofu. To be authorized,
evaporated milk + 12 oz. water = 24 oz. children in Food Package IV, up to the the tofu must be calcium-set (prepared
reconstituted milk) and would ensure maximum allowance for fluid milk, in with only calcium salts, e.g., calcium
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44801
sulfate), and may not contain added fats, Per cup protein is no longer a priority nutrient
sugars, oils or sodium. Under this for the WIC population. For fully
proposed rule, tofu is not allowed as a Vitamin A ................... 500 International breastfeeding women in Food Package
substitute for milk for children in Food Units (IU). VII, the maximum monthly allowance
Package IV without medical Vitamin D .................. 100 IU. would be 2 dozen eggs. The quantity of
documentation. Magnesium ................ 24 mg. eggs provided by the revised packages is
Phosphorus ............... 222 mg.
c. Authorized soy-based beverages. comparable with the average amount of
Potassium ................. 349 mg.
Section 102 of the Child Nutrition and Riboflavin .................. 0.44 mg. eggs consumed by children who are
WIC Reauthorization Act of 2004 Vitamin B12 ............... 1.1 mcg. participating in the WIC Program. (21)
(Public Law 108–265) requires that This proposed rule would allow the
nondairy beverages offered as an K. Cereal (for Women and Children) substitution of pasteurized liquid whole
alternative to fluid milk in the National eggs, or dried egg mix for fresh shell
School Lunch Program and School 1. Nomenclature eggs in these same food packages on an
Breakfast Program must be nutritionally This proposed rule would adopt the equivalent yield ready to eat versus
equivalent to fluid milk and meet term ‘‘breakfast cereal’’ as a substitute weight or volume basis to accommodate
nutritional standards set by the for the terms ‘‘cereal (hot or cold)’’ and differences among brands of these egg
Secretary of Agriculture. FNS believes ‘‘adult cereal (hot or cold)’’ currently products. The proposed rule would
that it is imperative for WIC and the used in § 246.10(c). FDA regulations (21 authorize hard boiled eggs, where
school nutrition programs to use the CFR 170.3(n)(4)) define breakfast cereals readily available for purchase in small
same standards for defining allowable as those including ready-to-eat and quantities, for homeless participants.
soy-based beverages as alternatives to instant and regular hot cereals. This M. Canned Fish
fluid milk. In setting minimum term is consistent with USDA’s long-
nutritional standards for soy-based standing interpretation of WIC cereals As recommended by the IOM, this
beverages, FNS considered the IOM (hot or cold) as meaning breakfast proposed rule would authorize 30
recommendations and Food and Drug cereals that are either ready-to-eat or ounces of a variety of canned fish that
Administration (FDA) standards, and those cereals (e.g., oatmeal, grits, cream do not pose a mercury hazard, as
examined the nutrient levels found in of wheat) that require the addition of a identified by federal advisories of the
various types of milk using the Nutrient liquid (e.g., water or milk) and heating Food and Drug Administration and the
Database for Dietary Studies. (20) IOM or cooking before being served. U.S. Environmental Protection Agency,
(22) in Food Package VII for fully
recommended allowing as milk
alternatives only soy-based beverages 2. Authorized Cereals breastfeeding women (currently
that are fortified to contain nutrients in As recommended by the IOM, this § 246.10(c)(7)). For ease of
amounts similar to cow’s milk. The IOM proposal would add new minimum administration by State agencies, to
also recommended minimum levels per requirements for WIC breakfast cereals accommodate participant preferences,
cup of 300 mg calcium and 120 in Food Packages III, IV, V, VI, and VII and to minimize intake of mercury, this
International Units (IU) vitamin D. FDA, (currently § 246.10(c)(3) through (c)(7)). proposed rule would authorize the
at 21 CFR Part 131, specifies that if To address current dietary guidance to following varieties of canned fish—light
added, milk should provide not less increase whole grains and lower tuna, salmon, and sardines. The
than 2000 IU vitamin A per quart (500 saturated fat and cholesterol, proposed Department seeks comments on
IU per cup) and 400 IU vitamin D per authorized WIC breakfast cereals must additional canned fish to offer in Food
quart (100 mg per cup.) Among the meet labeling requirements for making a Package VII. This proposed rule would
varieties of fluid milk, whole milk health claim as a ‘‘whole grain food clarify that fish packaged in foil bags
(3.25% milkfat) typically provides the with moderate fat content’’ as defined (‘‘pouches’’) are WIC-eligible.
lowest levels of several nutrients. Since by FDA in its December 9, 2003,
N. Juice
soy beverage may be allowed as a ‘‘Health Claim Notification for Whole
substitute for milk over a variety of fat Grain Foods with Moderate Fat This proposed rule would clarify that
content levels, a single, broadly Content’’ at http://www.cfsan.fda.gov/ authorized juices must be 100 percent
applicable standard is needed. Further, dms/flgrain2.html (e.g., must contain a unsweetened fruit/vegetable juice or
FNS believes that the statutory minimum of 51% whole grains). In blends of these juices, and contain a
requirement of Public Law 108–265 for addition, all authorized WIC breakfast minimum of 30 milligrams of vitamin C
nutritional equivalency takes cereals must continue to contain a per 100 milliliters of juice. This
precedence over the IOM minimum of 28 mg per iron per 100 proposed rule would clarify that juices
recommendations for WIC. Therefore, grams of dry cereal and not more than that are fortified with other nutrients
whole milk was used as a benchmark for 21.2 grams of sucrose and other sugars may be allowed at the State agency’s
all nutrients except vitamins A and D, per 100 grams of dry cereal (6 grams per option. This proposed rule would also
which already have Federally- dry ounce). In Food Package III, infant require that juices be pasteurized.
cereal may be substituted for breakfast The Department acknowledges that
established standards for fortification of
cereal for children and women. 100 percent citrus juices (i.e., orange,
fluid milk. The chosen levels of
grapefruit, tangerine and blends of these
vitamins A and D derive from the milk L. Eggs juices) should naturally contain at least
fortification levels required by the FDA.
This proposed rule would change the 30 milligrams of vitamin C per 100
Based on the above, this rule proposes
maximum monthly allowance for fresh milliliters of juice. To ease the
that authorized soy-based beverages
shell eggs from the current 2 or 21⁄2 to administrative burden on State agencies
provide, at a minimum, the following
jlentini on PROD1PC65 with PROPOSAL2
1 dozen fresh shell eggs for children and in approving juices, this proposed rule
nutrients:
women in Food Packages IV, V, and VI. would not require the verification of
Per cup
This recommendation is consistent with vitamin C content for 100 percent citrus
recommendations of the IOM (8) and the juices. However, verification of vitamin
Calcium ..................... 276 milligrams (mg). DGA 2005 (12) to reduce cholesterol. In C content for non-citrus juices would be
Protein ....................... 8 grams. addition, the IOM determined that 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 that this unique aspect of Food Package children who have a diagnosed medical
proposed rule would change the III be retained; however, it condition when the use of conventional
maximum monthly allowance of juice recommended that infants with foods is precluded, restricted or
for women and children in Food qualifying conditions be assigned to this inadequate to meet their nutritional
Packages IV, V, VI, and VII (currently food package to facilitate efficient needs. These medical conditions
§ 246.10(c)(4) through (c)(7)). For management and tracking of the benefits include, but are not limited to,
children in Food Packages III and IV, and costs of providing supplemental metabolic disorders, inborn errors of
the proposed maximum monthly foods to these participants. The IOM amino acid metabolism, gastrointestinal
allowance of juice is 128 fluid ounces of also recommended that the foods disorders, malabsorption syndromes
single strength juice (4.3 fluid ounces contained in Food Package III be and food allergies.
per day). For pregnant and partially restrictive only to the extent dictated by Infants with qualifying medical
breastfeeding women in Food Package V the participant?s health condition. This conditions currently receive either Food
and fully breastfeeding women in Food rule proposes these recommendations Package I, which serves infants 0–3
Package VII, the proposed maximum and, in addition, certain technical months of age, or Food Package II for
monthly allowance of juice is 144 fluid adjustments found necessary by the infants 4–12 months of age. These
ounces (4.8 fluid ounces per day). For Department. infants have the same diagnosed
postpartum women in Food Package VI, This rule proposes the following medical condition(s) cited for women
the proposed maximum monthly changes in Food Package III: and children who currently receive
allowance of juice is 96 fluid ounces • Adds medically fragile infants to Food Package III.
(3.2 fluid ounces per day). the population served; The Department is proposing to revise
In its Report, the IOM states that • Revises the maximum monthly § 246.10(c)(1) through (c)(3) of Program
deleting or reducing the quantity of allowances for WIC formulas; regulations for Food Packages I, II and
juice in the WIC food packages helps • Clarifies the purpose and the III in order to serve all medically fragile
allow for the inclusion of whole fruits qualifying conditions that it serves; participants with qualifying conditions,
and vegetables while containing food • Includes other WIC food(s), when including infants, with Food Package III.
costs. The reduction in the amount of not medically contraindicated, up to the The revised title for this food package
juice provided for children to about 4 same maximum monthly allowance would be ‘‘Food Package III—
ounces per day is consistent with the authorized for Food Packages II, and IV Participants With Qualifying
AAP recommendation for that age through VII; and Conditions’’. Under revised Food
group. (14) The AAP also notes that juice • Clarifies the physical forms of Package III, infants would receive
does not provide any additional authorized WIC-eligible medical foods. exempt infant formula and appropriate
nutritional benefit beyond that of whole Over the years the Department has supplemental foods for the age and
fruit. The reduced amount of juice for received numerous requests from WIC feeding option of the infant, when not
women is consistent with the State agencies, advocates and medically contraindicated; children and
recommendation of the DGA 2005 (12) participants to revise this food package adults would receive WIC formula
that whole fruits be used for a majority to better meet the needs of the medically (WIC-eligible infant formula, exempt
of the total daily amount of fruit. fragile. The Department recognizes that infant formula, or WIC-eligible medical
In Food Packages III, IV, V, VI and VII, this nutritionally vulnerable segment of food) and appropriate supplemental
this proposed rule would allow the the nation’s population has very special foods, when not medically
substitution of shelf-stable and frozen needs and WIC can assist in helping to contraindicated.
concentrated juices for single strength address many of those nutritional needs. Infants who do not have a qualifying
juice. The proposed rule would allow Some participants issued this food condition to receive exempt infant
combinations of single strength and package may require a type of formula formula in Food Package III would
concentrated juices provided that the for which there is no substitute and continue to be served either under Food
total volume does not exceed the their health would be seriously Package I or II, as deemed appropriate
maximum monthly allowance for single- jeopardized if they did not receive this for their age and feeding option. Both
strength juice. food package. Food Packages I and II would continue
The Department is proposing to revise to authorize a variety of WIC-eligible
O. Peanut Butter Food Package III to serve all medically infant formulas, consistent with Federal
This proposed rule clarifies that fragile WIC participants under the same WIC regulations, State agency policies
reduced fat peanut butter is an optional food package and to include other and authorization, and infant formula
alternative for regular peanut butter in supplemental foods when not medically rebate contract agreements with
Food Packages III, IV, V, VI and VII contraindicated. The Department manufacturers.
(currently § 246.10(c)(3) through (c)(7)) estimates that the current subgroup of
2. Qualifying Conditions Under Food
provided that it meets the FDA standard participants who have medical
Package III
of identity for peanut butter as defined conditions to receive Food Package III is
by 21 CFR 164.150. That is, it must only about 1–2 percent of the total WIC The Department is aware that in the
contain 90 percent peanuts by weight, caseload. The inclusion of other past some State agencies have
contain no more than 10 percent by supplemental foods in this food package experienced difficulty in determining
weight of seasonings and stabilizing would provide flexibility in which medical conditions qualify under
ingredients, and contain no more than accommodating the wide range of Food Package III. For these reasons, this
55 percent of fat by weight. different nutritional needs of the proposed rule would clarify the types of
participants served by this food conditions that would qualify
P. Revisions in Food Package III and
jlentini on PROD1PC65 with PROPOSAL2
package. participants as medically fragile
Their Effect on Food Packages I and II participants eligible to receive Food
Food Package III (currently 1. Categories of Participants Served by Package III. Food Package III would be
§ 246.10(c)(3)) was initially designed for Food Package III reserved for participants who have one
women and children with special Food Package III (currently or more qualifying conditions and, as a
dietary needs. The IOM recommended § 246.10(c)(3)) serves only women and result of the qualifying condition,
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44803
require a WIC formula (infant formula, a non-qualifying condition, such as a • WIC-eligible medical foods are
exempt infant formula or WIC-eligible food dislike, or food intolerance (i.e. specifically formulated to provide
medical food) to supplement their lactose intolerance) or a suspected but nutritional support for participants with
nutrition needs as determined by the unconfirmed allergy (i.e. milk protein a diagnosed medical condition.
participant?s health care professional allergy). Currently other supplemental The Department proposes to revise
who is licensed to write medical foods, such as cheese and lactose-free the existing definition for ‘‘WIC-eligible
prescriptions under State law. The WIC milk, are available and encouraged to medical foods’’ in § 246.2 to clarify that
formulas prescribed in this food package address lactose intolerance. Proposed medical foods are designed for children
provide nutritional support for specific food packages IV–VII , described in (12 months and older) and adults.
conditions that are clinically serious or sections V.C. and V.D. of this preamble, Infants served under Food Package III
life-threatening and are generally include new foods as substitutes or cannot receive WIC-eligible medical
required for long periods of time. The alternatives to milk, such as soy-based foods.
qualifying conditions include but are beverage and calcium-set tofu, that may
not limited to premature birth, low birth provide more flexibility to the State and 6. Products Not Authorized as WIC
weight, failure to thrive, inborn errors of the participant, may be easier to obtain Formulas
metabolism and metabolic disorders, in retail establishments, and may be Products not authorized as WIC
gastrointestinal disorders, more appropriate to meet the nutritional formulas or foods in Food Package III or
malabsorption syndromes, immune needs of the participants who do not any other food package include, but are
system disorders, severe food allergies have a qualifying condition. The use of not limited to:
that require an elemental formula, and conventional foods when appropriate is • Medicines or drugs, as defined and
life threatening disorders, diseases and important due to the additional regulated under the Food, Drug and
medical conditions that impair nutrients, fiber and other benefits that Cosmetic Act (21 U.S.C. 301 et seq.), as
ingestion, digestion, absorption or the conventional foods provide. WIC amended;
utilization of nutrients that could nutrition education supports the • Parenteral or intravenous nutrition
adversely affect the participant?s importance of obtaining nutrients from products;
nutrition status. foods when appropriate and that a • Enzymes;
balanced diet remains the preferred • Flavoring and thickening agents;
3. Restricted Uses of Food Package III • Oral rehydration fluids or
overall source of nutrients.
Under this proposed rule, Food electrolyte solutions;
Package III would not be authorized for 4. Authorized Foods in Food Package III • Sports or breakfast drinks; and
infants whose only condition is: Section 246.10(c)(3) of current • Over-the-counter weight control/
• A diagnosed formula intolerance or regulations lists the authorized foods for loss products.
food allergy to lactose, sucrose, milk children and women receiving Food In addition, all apparatus or devices
protein, or soy protein that does not Package III as WIC formula (infant (e.g., feeding tubes, bags and pumps)
require the use of an exempt infant formula, exempt infant formula and designed to administer WIC formulas
formula; or WIC-eligible medical foods), cereal and are not WIC-allowable costs.
• A non-specific formula or food juice. As recommended by the IOM, this 7. Physical Forms of WIC Formulas
intolerance. proposed rule would expand the WIC
Infants with these infant formula food categories offered in Food Package a. Current Physical Forms. WIC
intolerances or food allergies would not III of WIC formula, cereal and juice by regulations for Food Packages I, II and
receive revised Food Package III but adding milk and milk alternatives, fruits III (§ 246.10(c)(1) through (c)(3)) identify
instead would receive either revised and vegetables, eggs, whole wheat the three physical forms of WIC
Food Package I or II based on age and bread, legumes and/or peanut butter, formulas as concentrated liquid, powder
feeding option, as described in section cheese, fish and infant foods, as and ready-to-feed (RTF) in liquid form.
V.B. of this preamble. Food Package I medically appropriate and prescribed. b. Ready to Feed in Other Than Liquid
and II have collectively provided infant Exempt infant formula would be the Forms. New formulas and medical foods
formulas that are soy-based, lactose-free, only WIC formula authorized for infants have been developed due to
or sucrose-free to accommodate most in revised Food Package III. Infant advancements in technology and these
food intolerances or food allergies. formula, exempt infant formula and products do not strictly conform to the
While commercially available infant WIC-eligible medical foods would be current physical form descriptions.
formulas in the United States may vary authorized for children and women in While different forms of infant formula
by containing different ingredients to revised Food Package III. and exempt infant formula could be
address such intolerances and allergies, developed, it is anticipated that the
these infant formulas are still 5. Authorized WIC Formulas largest variety of physical forms will be
considered to be infant formulas (as Current authorized WIC formulas within the WIC-eligible medical foods
opposed to exempt infant formulas) as (infant formulas, exempt infant category. The forms of WIC-eligible
long as the definition and requirements formulas, and WIC-eligible medical medical foods currently available
of § 246.2 are met. Therefore, Food foods) are defined in § 246.2 of WIC include, but are not limited to, ready-to-
Packages I and II would continue to regulations. feed bars, ready-to-eat puddings, and
authorize a variety of infant formulas, WIC formulas are generally described gels and capsules specifically designed
consistent with State agency policies as follows: for inborn errors of metabolism. The
and infant formula rebate contract • Infant formulas are food substitutes Department has determined that some of
agreements with manufacturers for for human milk for generally healthy, these products meet the minimum
jlentini on PROD1PC65 with PROPOSAL2
infants with food intolerances and/or full-term infants; Federal WIC requirements for a WIC-
food allergies who do not have • Exempt infant formulas are food eligible medical food, however the
qualifying conditions in order to receive substitutes for human milk for both pre- technical guidance regarding how to
exempt infant formulas. term or full-term infants who have a determine maximum monthly
Proposed Food Package III would not nutritionally-related medical problem; allowances is being considered in light
be authorized for a child or woman with and of the IOM report recommendations that
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44804 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
powder and ready-to-feed forms may be consultation with the participant’s supplemental foods up to the maximum
substituted for liquid concentrate on an attending health care provider when monthly amounts with medical
equivalent nutritional basis. Inclusion of appropriate, to determine and document documentation—milk and milk
these additional forms of WIC-eligible if a WIC formula in a RTF form is alternatives, juice, breakfast cereal (hot
medical foods into Federal WIC required. or cold), eggs, fruits and vegetables,
regulations and their appropriate whole wheat bread or other whole
8. Maximum Monthly Allowances for
maximum monthly allowances would grains, legumes, and peanut butter.
Food Package III d. Postpartum. A non-breastfeeding
increase flexibility for State agencies to
help meet the nutritional needs of the As recommended by the IOM, this postpartum woman (up to 6 months
medically fragile participant. FNS is proposed rule would revise Food postpartum) or a breastfeeding
seeking comments on the appropriate Package III to serve medically fragile postpartum woman (up to 6 months
equivalent standard to be used (e.g., women, infants and children with postpartum) whose partially breastfed
protein equivalent, kilocalorie qualifying conditions. These infant receives formula in amounts that
equivalent, volumetric or weight participants would receive up to the exceed the maximum allowances
equivalent, number of serving same maximum monthly amounts of provided by Food Packages I or II for
equivalents, and/or other type of supplemental foods unless medically partially breastfeeding infants, as
equivalent) to determine maximum contraindicated, as those same appropriate for the age of the infant, and
monthly allowances for WIC-eligible participant categories (infants, children, who has a documented qualifying
medical foods in these new physical pregnant or partially breastfeeding condition would receive up to 455 fluid
forms (e.g., bars, gels, and capsules) for women, non-breastfeeding postpartum ounces in liquid concentrate form of
those medically fragile participants women, and fully breastfeeding women) WIC Formula (infant formula, exempt
served by Food Package III. Comments who do not have a qualifying condition. infant formula or WIC-eligible medical
are also requested regarding how to a. Infants, ages birth through 11 food). Formulas in other forms, such as
determine maximum monthly months. Infants with a qualifying powder or RTF, could be substituted by
allowances for WIC-eligible medical condition would receive exempt infant providing nutritional equivalent
foods prescribed to children and women formula and infant foods in up to the amounts. Unless medically
that are only available in ready-to-feed same maximum monthly allowances as contraindicated, the participant may
forms such as capsules or gels and infants of the same age and feeding receive any or all of the following
therefore the liquid concentrate option with no qualifying condition supplemental foods up to the maximum
equivalent does not exist. who are issued Food Packages I or II monthly amounts with medical
c. Restrictions for Issuing RTF Forms unless medically contraindicated. documentation—milk and milk
of WIC Formulas. Current regulations b. Children, ages 1 year through 4 alternatives, juice, breakfast cereal (hot
(§ 246.10(c)(1)(ii)) governing Food years. A child with a qualifying or cold), eggs, fruits and vegetables,
Packages I and II restrict the issuance of condition would receive up to 455 fluid legumes, or peanut butter.
WIC formulas in RTF liquid form to ounces in liquid concentrate form of e. Fully breastfeeding. A fully
only the following conditions: WIC Formula (infant formula, exempt breastfeeding woman (up to 1 year
• The participant’s household has an infant formula, or WIC-eligible medical postpartum) whose infant does not
unsanitary or restricted water supply or food). Formulas in other forms, such as receive formula from WIC; all
poor refrigeration. powder or RTF could be substituted by breastfeeding women during the first
• The participant or person caring for providing nutritional equivalent month postpartum; women pregnant
the participant may have difficulty in amounts. Unless medically with two or more fetuses; and women
correctly diluting concentrated forms or contraindicated, the participant may partially breastfeeding multiple infants
reconstituting powder forms, or the WIC receive any or all of the following (up to 1 year postpartum) with a
formula is only available in RTF form. supplemental foods in up to the qualifying condition would receive up
This proposed rule would continue to maximum monthly amounts with to 455 fluid ounces in liquid
include these same restrictions for medical documentation—milk and milk concentrate form of WIC Formula
issuing a WIC formula in a RTF form alternatives, juice, breakfast cereal (hot (infant formula, exempt infant formula,
issued under revised Food Package III. or cold), eggs, fruits and vegetables, or WIC-eligible medical food). Formulas
However, recognizing the needs of whole wheat bread or other whole in other forms, such as powder or RTF,
participants with qualifying conditions, grains, legumes, or peanut butter. could be substituted by providing
this proposed rule would expand upon c. Pregnant or partially breastfeeding. nutritional equivalent amounts. Unless
these restrictions to also authorize a A pregnant, or partially breastfeeding medically contraindicated, the
RTF form in Food Package III when the woman, whose participating infant participant may receive any or all of the
product: receives formula in amounts that do not following supplemental foods up to the
• Better accommodates the exceed the maximum allowances maximum monthly amounts with
participant’s medical condition (e.g., provided by Food Packages I or II for medical documentation—milk and milk
RTF semi-solids for swallowing partially breastfeeding infants, as alternatives, juice, breakfast cereal (hot
disorders and RTF forms to reduce the appropriate for the age of the infant, and or cold), cheese, eggs, fruits and
possibility of food contamination and who has a documented qualifying vegetables, whole wheat bread or other
risk of infection in cases of immune condition would receive up to 455 fluid whole grains, fish (canned), legumes,
system disorders); or ounces in liquid concentrate form of and peanut butter. Women fully
• Improves the participant’s WIC Formula (infant formula, exempt breastfeeding multiple infants (up to 1
compliance in consuming the infant formula, or WIC-eligible medical year postpartum) with a qualifying
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prescribed formula (e.g., improved taste food). Formulas in other forms, such as condition would be prescribed 1.5 times
of RTF solid bars versus RTF liquid powder or RTF could be substituted by the maximum amounts of supplemental
forms of WIC-eligible medical foods). providing nutritional equivalent foods provided by Food Package III with
This proposed rule would continue to amounts. Unless medically medical documentation.
authorize the WIC local agency contraindicated, the participant may The Department recognizes that the
competent professional authority, in receive any or all of the following types of qualifying conditions
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44805
warranting Food Package III are varied • Establish policies and procedures (infant formula, exempt infant formula
and can impose different dietary for issuing exempt infant formulas and or WIC-eligible medical food). The
restrictions on participants. For WIC-eligible medical foods to WIC current medical documentation
example, the presence of an inborn error participants who are able to meet any technical requirements
of amino acid metabolism, such as portion of their exempt infant formula (§ 246.10(c)(1)(v)(B)) are:
phenylketonuria, known as PKU, would and WIC-eligible medical foods needs • The brand name of the WIC formula
severely limit the types of traditional through these other programs; and prescribed;
foods a participant could have, • Assist WIC participants in quickly • Medical diagnosis warranting the
especially those high in protein. For obtaining from the other programs any WIC formula;
these participants, the maximum exempt infant formula and WIC-eligible • Length of time the prescribed WIC
monthly allowances of a WIC formula medical foods needs beyond the formula is medically required by the
may be warranted to meet their special maximum monthly allowances that may participant; and
protein needs, but some of the food be needed to meet the amount • The signature (or name, if the initial
categories of the other allowable prescribed. documentation was received by
supplemental foods (e.g., eggs, legumes telephone) of the requesting health care
and fish) may be medically prohibited. 10. Infant Cereal in Food Package III
provider.
The combination of WIC food options Longstanding policy has allowed Medical documentation may be
made available under revised Food infant cereal to be substituted for hot or provided as an original written
Package III would provide flexibility in cold cereal intended for children and document, electronically, by facsimile
accommodating the wide range of adults in Food Packages III whenever or by telephone to the competent
different nutritional needs of the infant cereal was needed to better meet professional authority who must
participants served by this food participants’ nutritional needs due to promptly document the information.
package. qualifying conditions. However, this However, the receipt of medical
9. Coordination with Other Programs provision was never incorporated into documentation by telephone may only
That Provide or Reimburse for Formulas regulatory language for these food be used when absolutely necessary on
packages. an individual participant basis to
This proposal would require WIC The iron content of infant cereal is
State agencies to coordinate with other prevent undue hardship to a participant
higher and in a form that is better or to prevent a delay in the provision of
Federal, State, or local government absorbed than the iron in adult cereal.
agencies or with private agencies that infant formula that would place the
In addition, infant cereal has a finer participant at increased nutritional risk.
operate programs that also provide or texture than adult cereal for easier
reimburse, or could provide or Section 246.10(c)(1)(v)(B) of current
swallowing. Therefore, women and WIC regulations requires that this
reimburse, for exempt infant formula children who have increased iron
and WIC-eligible medical food benefits information be documented in writing
requirements, developmental delays, or and kept on file at the WIC local clinic.
that may be authorized by WIC State swallowing disorders may benefit from
agencies. Therefore, receipt of medical
receiving infant cereal in lieu of adult documentation via the telephone must
Such coordination recognizes that cereal.
WIC participants could fully participate be followed by written documentation.
This rule proposes to authorize only
in and benefit from other assistance in Food Package III the substitution of 2. Proposed Requirements
programs. At a minimum, WIC State 32 dry ounces of infant cereal for 36 dry
agencies would be required to This proposed rule would continue to
ounces of adult cereal for children and require medical documentation for any
coordinate with the Medicaid Program women when the WIC competent
regarding the provision of exempt infant contract brand infant formula that does
professional authority or the supporting not meet the requirements of an infant
formulas and WIC-eligible medical medical prescription documents that
foods prescribed for WIC participants formula as specified in Table 4 of
this provision is necessary. The § 246.10(e)(12) of the proposed rule, any
who are also Medicaid recipients. The Department believes that the vast
WIC State agency would be responsible non-contract brand infant formula, any
majority of children and women who exempt infant formula, or any WIC-
for providing up to the maximum would require this cereal substitution
amount of exempt infant formulas and eligible medical food. In addition,
would be served in Food Package III medical documentation would be
WIC-eligible medical foods under Food rather than the other food packages.
Package III in situations where required for certain milk alternatives for
reimbursement is not provided by Q. Medical Documentation and children and women as described in
another entity. Supervision Requirements for Food section V.J. of this preamble and for any
In coordinating with programs on the Packages I through VII supplemental foods authorized in
provision of WIC-authorized exempt proposed Food Package III for
1. Current Requirements participant’s with certain qualifying
infant formulas and WIC-eligible
medical foods, the Department strongly Federal WIC regulations at conditions as described in section V.P.
encourages WIC State agencies to: § 246.10(c)(1)(iii)(A) through of this preamble. In addition to retaining
• Become knowledgeable of the (c)(1)(iii)(D) require medical all of the current medical
participant eligibility criteria for documentation for the issuance of any documentation requirements, this
receiving exempt infant formula and contract brand infant formula that does proposed rule would add the following
WIC-eligible medical foods benefits not meet the requirements of an iron requirements to medical documentation:
from other programs; fortified infant formula; any non- • Contact information for the
jlentini on PROD1PC65 with PROPOSAL2
• Implement a formula agreement or contract brand infant formula; any participant’s healthcare provider who
memorandum of understanding with exempt infant formula; or any WIC- makes the medical determination;
these other programs to share the eligible medical food. The medical • Date of medical determination;
responsibility of meeting the exempt documentation is intended to verify that • Name of specific supplemental
infant formula and WIC-eligible medical the participant has a medical condition food(s) to be prescribed;
foods need of mutual participants; that dictates the use of a WIC formula • Amount prescribed per day;
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44806 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
• Medical determination of a • Maximum monthly allowances of Recommendations.’’ (2) Developing,
qualifying condition which warrants the WIC formula (meaning infant formula, reviewing, and analyzing cultural food
issuance of the specific supplemental exempt infant formula and WIC-eligible package proposals is a time consuming
food(s); and medical foods) and specific process for WIC State agencies and the
• Length of time the specific supplemental food(s) authorized; and Department. Because the increased
supplemental food(s) is medically • Related State agency policies and variety and choice in the supplemental
required. procedures for issuing WIC formulas foods proposed in this rule will provide
All required medical documentation and specific supplemental foods(s) that State agencies increased flexibility in
necessary for the issuance of require medical documentation. prescribing culturally appropriate
supplemental foods including WIC State agencies are encouraged to packages for diverse groups, the
formulas would continue to be received develop a standardized form for health Department proposes to no longer
as an original written document, an care professionals to use in prescribing consider WIC State agency proposals for
electronic document, or received by Food Package III to help ensure that the cultural accommodations. While we
facsimile or telephone and kept on file. WIC local clinics obtain the required acknowledge that the future
This proposed rule would broaden the medical documentation. demographics of WIC participants may
file requirement to allow electronic R. Flexibility and Variety change, WIC is a supplemental program,
medical documentation files. and is not intended to provide all of the
As recommended by the IOM, WIC foods that may meet cultural food
Medical documentation requirements State agencies are encouraged to allow
for specific supplemental foods that do preferences. Future reviews of the WIC
as much variety and choice from the food packages by the Department will be
not usually require a prescription in proposed authorized foods as is feasible
order to obtain the food(s) are used to determine the need for
considering cost constraints and additional cultural accommodations.
established to ensure that the availability. Providing more variety and
participant’s healthcare professional, choice will facilitate the tailoring of T. General Provisions That Affect All
licensed in the State to write food packages to specific situations, WIC Food Packages
prescriptions, has determined that the especially for different ethnic or cultural
supplemental foods are not medically 1. State Authority to Determine Brands
groups.
contraindicated by the participant’s This rule proposes that State agencies This rule would clarify that State
condition. make available to participants at least agencies have the authority to establish
3. Roles of the State-Licensed Health two fruits and two vegetables from the additional criteria for WIC-authorized
Care Provider and WIC Competent category of fruits and vegetables (fresh foods that exceed Federal requirements.
Professional or processed) in each authorized food These State criteria could address, but
package. However, it is the not be limited to:
Due to the nature of the health Department’s expectation that more • Other nutritional standards;
conditions of participants who would than two varieties each of fruits and • Competitive cost;
receive Food Package III, close medical vegetables be authorized by State • State-wide availability; and
supervision is essential for each agencies and encourages States to offer • Participant appeal.
participant’s overall dietary participants the widest variety of fruit
management. The Department considers 2. Nutrition Tailoring
and vegetable options practicable. This
it appropriate that the responsibility for rule also proposes that State agencies Nutrition tailoring is a process of
this close medical supervision remain make available to participants more modifying the standard food package to
with the participant’s health care than one food type from each WIC food better meet the supplemental nutrition
provider. This proposed rule would category in each authorized food needs of participants. Nutrition tailoring
consider it the responsibility of the WIC package, except for the categories of entails making changes or substitutions
competent professional authority to peanut butter and eggs. to food types (e.g., dry beans vs. peanut
ensure that only the amounts of WIC butter), physical food forms (e.g. dry
formula and supplemental foods up to S. Cultural Food Package Proposals milk vs. fluid milk), and to quantities of
the regulatory maximum amounts The IOM was charged with foods.
prescribed by the participant’s health considering the cultural needs of WIC Current FNS policy allows both
care provider are issued in the participants and its recommendations categorical and individual nutrition
participant’s food package. for revisions to the WIC food packages tailoring of WIC food packages.
reflect those considerations. The IOM’s Individual nutrition tailoring is based
4. State Agency Guidance to Local
recommendations, as put forth in this on the Competent Professional
Agencies
proposed rule, include allowing Authority’s assessment of the
The Department encourages State participants a broad selection of fruits participant’s supplemental nutrition
agencies to develop guidance for their and vegetables, tofu and soy-based needs. Categorical nutrition tailoring for
local agencies and clinic sites, including beverages as substitutes for milk, participant groups or subgroups with
but not limited to guidance in the participant choice for whole grains similar supplemental nutrition needs is
State’s procedure manual, to use in (including tortillas), and salmon and based on scientific nutrition rationale
assisting the participant to obtain the sardines as substitutions for tuna. and State established policies.
required medical documentation for IOM’s recommendations, as largely According to the IOM, the proposed
receiving Food Package III or the milk put forth in this proposed rule, include revised food packages have the potential
alternatives for children and women in those foods that State agencies and to address current nutrient inadequacies
jlentini on PROD1PC65 with PROPOSAL2
Food Packages IV–VII and for health participants have requested over the and excesses; discrepancies between
care professionals in local communities. years to accommodate cultural needs of dietary intake and dietary guidance; and
Such guidance should assist local participants. In addition, the IOM current and future health-related
agencies in identifying and recommendations reflect those put forth problems in WIC’s target population.
understanding: in NWA’s Position Paper—‘‘NWA WIC The IOM recommends that the revised
• Qualifying conditions; Culturally Sensitive Food Prescription food packages be provided to each
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44807
participant in full, except to the extent communal food service. This restriction subdivide breastfeeding women as
that the packages are tailored to the would not preclude the provision or use either fully breastfeeding or partially
needs of individual WIC participants. of supplemental foods for an individual breastfeeding. For fully and partially
Therefore, this proposed rule would participant in a: breastfeeding women, the most
prohibit categorical nutrition tailoring, • Non-residential setting (e.g., child substantial food package changes
but continue to allow individual care facility, family day care home, include the addition of the $8.00 cash
nutrition tailoring based on the school, or other educational program); value voucher for fresh fruits and
Competent Professional Authority’s • Homeless facility; or vegetables and whole wheat bread (or
assessment of a participant’s • At the State agency’s discretion, a other whole grain options). Also, fully
supplemental nutrition needs. residential institution (e.g., home for and partially breastfeeding women may
Provisions of less than the maximum pregnant teens, prison, or residential receive soy-based beverage or tofu in
monthly allowances of supplemental drug treatment center) that meets the addition to cheese as a substitute for
foods to an individual WIC participant requirements currently set forth in milk. Recognizing that the ‘‘fully
would be appropriate when: § 246.7(n)(1) and (n)(2). breastfeeding woman’’ is likely to be the
• Medically or nutritionally U. Implementation of Revised Food same individual who under the current
warranted (e.g., to eliminate a food due Packages food package system receives Food
to a food allergy); Package VII, the enhanced breastfeeding
• A participant refuses or cannot use The proposed revisions to the WIC
package, the Department believes that a
the supplemental foods; or food packages will result in substantial
one-year implementation timeframe for
• The quantities necessary to changes to all aspects of program
these changes is appropriate.
supplement another program’s operations including management
information systems, nutrition For partially breastfeeding women,
contribution to fill a medical
education and counseling, vendor the IOM recommends changes that
prescription would be less than the
authorization, training and strengthen and support breastfeeding as
maximum monthly allowances.
management, and, breastfeeding the optimal infant feeding choice and
Consistent with current FNS policy,
promotion and support. The Department that support WIC’s breastfeeding
reductions in amounts of supplemental
seeks comments from State agencies on promotion efforts. However, the IOM
foods could not be made for cost-
the type and scope of administrative was concerned about the impact of the
savings, administrative convenience,
burden that may be associated with food package changes that support and
caseload management, or to control
implementing the provisions in this promote breastfeeding on the mother/
vendor abuse. However, State agencies
proposed rule. infant dyad, particularly not allowing
could continue to make administrative
In its report, the IOM identified partially breastfeeding status during the
adjustments for economic purposes.
certain proposed changes that were so infant’s first month of life. While there
Acceptable administrative adjustments
significant that it recommended pilot is empirical evidence that shows early
decrease cost while maintaining the
testing or limited application of the supplementation with infant formula is
nutrition integrity of the food packages
changes before full-scale associated with shorter duration of
and include such decisions as
implementation by all State agencies. As breastfeeding, particularly exclusive
eliminating expensive brands,
such, the Department seeks comments breastfeeding, some mothers who might
packaging or physical forms of WIC
on the following proposed otherwise try breastfeeding may choose
supplemental foods.
implementation plan that is designed to formula feeding to be sure they can
3. Homeless Participants address the IOM recommendation for obtain formula from WIC if they run
This proposal clarifies that State testing of certain provisions while into breastfeeding difficulties.
agencies would continue to have the allowing State agencies sufficient time Recognizing the potential impacts
authority to make food package and broad flexibility to implement the associated with proposed changes to the
adjustments to better accommodate majority of the food packages. partially breastfeeding woman’s
homeless participants. 1. Pregnant Women—The most package, the Department is proposing to
significant changes to the food package analyze and assess the proposed
4. Individual Use by Participants for pregnant women include the changes before proceeding to full
The WIC food packages are individual addition of the $8.00 cash value voucher implementation. The Department
food prescriptions that, in order to have for fresh fruits and vegetables and whole believes that an experimental design
the full effect on improving a wheat bread (or other whole grain with random assignment of mother-
participant’s nutritional status, are options). Also, pregnant women may infant dyads is impractical. Therefore,
intended to be consumed only by the receive soy-based beverage or tofu in the Department proposes to limit to not
participant and not by other family addition to cheese as a substitute for more than 4 sites within up to eight
members. milk. The Department is proposing a State agencies (32 total local sites) the
one-year implementation timeframe for ability to implement the partially
5. Settings for Participant Use of breastfeeding food package changes.
these changes.
Supplemental Foods 2. Postpartum Women—The primary After the Department has had an
Under this proposal, State or local changes to the food package for opportunity to examine the effects of the
agencies would have to advise postpartum women include the addition revised changes on the initiation and
participants that the supplemental foods of the $8.00 cash value voucher for fresh duration of breastfeeding (based on a
issued are only for their personal use. fruits and vegetables and the option to comparison of the experiences in the
Supplemental foods would not be receive soy-based beverage or tofu in test sites to comparison sites in the
jlentini on PROD1PC65 with PROPOSAL2
authorized for participant use while addition to cheese as a substitute for selected State agencies), the Department
hospitalized on an in-patient basis. In milk. The Department is proposing a will determine when all State agencies
addition, consistent with one-year implementation timeframe for can implement the revised partially
§ 246.7(n)(1)(i)(B), supplemental foods these changes. breastfeeding women’s food package.
would not be authorized for use in the 3. Breastfeeding Women—The The State agencies will be selected
preparation of meals served in a proposed food package changes based on willingness and ability to
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44808 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
cooperate with evaluation data breastfed. The other changes include a include the addition of the $6.00 cash
collection and design protocols reduction of the amount of infant value voucher for fresh fruits and
(including identification of appropriate formula that can be received from WIC, vegetables and whole wheat bread (or
comparison sites for the 4 test sites elimination of juice and the addition of other whole grain options), and the
within the State), past breastfeeding infant food fruits and vegetables. As reductions in the amounts of milk and
rates in the State (the Department noted above, the IOM was concerned juice. Also, children 2 years of age and
proposes to seek a range of high, about the impact of the recommended older may no longer receive whole milk.
medium and low past breastfeeding food package changes on the Cheese remains a substitute for milk.
rates), adequacy of the infrastructure in breastfeeding mother/infant dyad. The Department is proposing a one-year
place to provide the necessary support Therefore, the Department proposes to implementation timeframe for these
to breastfeeding mothers (the limit the ability to implement the changes.
Department proposes to seek both ‘‘best partially breastfed infant food packages
case’’ and ‘‘average case’’ levels of 6. Participants with Qualifying
changes to not more than 32 sites within
infrastructure), ability of the Conditions—The most significant
up to eight State agencies selected to
management information system to implement the partially breastfeeding changes to the food package that address
provide requested data on the impact of woman’s food package. After the the dietary needs of participants’ with
the food package changes, and diversity Department has had an opportunity to certain qualifying conditions is the
of the population to receive the new examine the effects of the revised addition of other supplemental food(s),
food package. changes on the initiation and duration when not medically contraindicated,
4. Infants—The proposed food of breastfeeding (based on a comparison and serving all medically fragile
package changes subdivide infants as of the experiences in the test sites to participants under one food package
fully formula fed, fully breastfed or comparison sites in the eight State (Food Package III). Women, infants and
partially breastfed. In addition, the food agencies), the Department will children with qualifying conditions
packages for fully formula fed infants determine when all State agencies can would receive the same maximum
are designated as birth through 3 implement the revised partially monthly amounts of supplemental
months; 4 through 5 months; and 6 breastfed infant food package. The State foods, with medical documentation, as
through 11 months. The food packages agencies will be selected based on those same participant categories that
for partially breastfed infants are willingness and ability to cooperate do not have a qualifying condition. The
designated as 1 through 3 months, 4 with evaluation data collection and Department is proposing a one-year
through 5 months, and 6 through 11 design protocols (including implementation timeframe for these
months. The infant food packages for identification of appropriate comparison changes.
fully breastfed infants are designated as sites for the test sites), past The following chart summarizes the
birth through 5 months, and 6 through breastfeeding rates in the State (the proposed implementation timeframes
11 months. Department proposes to seek a range of
For the fully formula fed infant, the on which the Department is seeking
high, medium and low past comments. As noted, in most instances
amount of infant formula has been
breastfeeding rates), adequacy of the State agencies will have one year to
reduced for the 6 through 11 month old.
infrastructure in place to provide the implement the new food packages.
This reduction has been offset by the
necessary support to breastfeeding During the one-year phase-in period,
addition of infant food fruits and
mothers (the Department proposes to State agencies would be required to
vegetables. However, the amount of
seek both ‘‘best case’’ and ‘‘average issue food benefits based on either the
infant formula has been increased for
case’’ levels of infrastructure), ability of new food packages or current food
the 4 through 5 month old. Also, juice
has been eliminated. The Department the management information system to packages but could not combine the
proposes a six-month timeframe to provide requested data on the impact of two. For example, a State agency could
implement the elimination of juice and the food package changes, and diversity not add whole wheat bread and fresh
a one-year timeframe to implement the of the population to receive the new fruits and vegetables to the current
remaining changes in the fully formula food package. foods and quantities available under the
fed package. For the fully breastfed infant, the most children’s food package. The State
For the partially breastfed infant significant change is the addition of agency may, however, phase-in the new
category, the most significant change is infant fruits and vegetables, and infant food packages on a participant category
the inability to receive any WIC infant meats. The Department believes that a basis. To minimize participant and
formula during the first month one-year implementation timeframe for vendor confusion, the Department
following birth. In the first month after these changes is appropriate. proposes that once the State agency
birth there are only two feeding 5. Children—The most significant begins issuing the new food packages, it
options—fully formula fed or fully changes to the child’s food package 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 One Year from Publication of Interim Rule (The selected sites
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each of up to 8 State agencies) 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 One Year from Publication of Interim Rule (The selected sites
Breastfeeding Women’s Package will have authority to issue the revised packages for no more
than 3 years.)
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44809
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 All State Agencies .............................. Six months from Publication of Interim Rule.
Packages.
Children ................................................ All State Agencies .............................. One Year from Publication of Interim Rule.
Participants with Certain Medical Con- All State Agencies .............................. One Year from Publication of Interim Rule.
ditions (Women, Infants and Chil-
dren)
VI. Endnotes (12) U.S. Department of Health and Human Need to Know About Mercury in Fish and
Services/U.S. Department of Agriculture, Shellfish.’’ EPA and FDA Advice for: Women
(1) NAWD (National Association of WIC Dietary Guidelines for Americans, 2005. Who Might Become Pregnant, Women Who
Directors) 2000. ‘‘NAWD WIC Food Available at Internet site: http:// Are Pregnant, Nursing Mothers, and Young
Prescription Recommendations, 2000.’’ www.healthierus.gov/dietaryguidelines/. Children. 2004. Available at Internet site:
Copies may be purchased by telephoning the (13) Institute of Medicine, National http://www.cfsan.fda.gov/dms/
National WIC Association at (202) 232–5492. Academy of Sciences, 2001. ‘‘Dietary admehg3.html.
(2) NWA (National WIC Association). 2003. Reference Intakes for Vitamin A, Vitamin K,
‘‘NWA WIC Culturally Sensitive Food Arsenic, Boron, Chromium, Cooper, Iodine, VII. Procedural Matters
Prescription Recommendations.’’ Position Iron, Manganese, Molybdenum, Nickel,
Paper No. 03–001. Copies may be purchased Executive Order 12866
Silicon, Vanadium, and Zinc.’’ National
by telephoning the National WIC Association Academy Press. This proposed rule has been
at (202) 232–5492. (14) American Academy of Pediatrics, determined to be economically
(3) Institute of Medicine, National Committee on Nutrition. ‘‘The use and significant and was reviewed by the
Academy of Sciences. ‘‘WIC Food Packages: misuse of fruit juice in pediatrics.’’ Office Management and Budget in
Time for a Change,’’ 2005. Available at ‘‘Pediatrics’’ 107(5):1210–1213, May 2001.
Internet site: http://www.fns.usda.gov/oane/
conformance with Executive Order
Available at Internet site: http://
menu/Published/WIC/FILES/ www.aap.org/policy/re0047.html.
12866.
Time4AChange(mainrpt).pdf. (15) American Academy of Pediatrics, Regulatory Impact Analysis
(4) Institute of Medicine, National Committee on Nutrition, 2004. ‘‘Pediatric
Academy of Sciences, 1997. Dietary Nutrition Handbook.’’ 5th edition. As required for all rules that have
Reference Intakes for Calcium, Phosphorus (16) U. S. Department of Health and been designated as Significant by the
Magnesium, Vitamin D, and Fluoride. Human Services, ‘‘Healthy People 2010: Office of Management and Budget, a
Washington, DC: National Academy Press. Understanding and Improving Health, 2nd Regulatory Impact Analysis (RIA) was
(5) Institute of Medicine, National edition.’’ U.S. Government Printing Office. developed for this proposed rule. It
Academy of Sciences, 1998. Dietary Available at Internet site: http:// follows this regulation as an Appendix.
Reference Intakes for Thiamin, Riboflavin, www.healthypeople.gov/document. The conclusions of this analysis are
Niacin, Vitamin B6, Folate, Vitamin B12, (17) American Academy of Pediatrics,
Pantothenic acid, Biotin and Choline. Section on Breastfeeding, 2005.
summarized below.
Washington, DC: National Academy Press, ‘‘Breastfeeding and the use of human milk.’’ Need for Action. As the population
1998. ‘‘Pediatrics’’ 115(2):496–596. Available at served by WIC has grown and become
(6) Institute of Medicine, National Internet site: http:// more diverse over the last 20 years, the
Academy of Sciences, 2000. Dietary aappolicy.aappublications.org/cgi/content/ nutritional risks faced by participants
Reference Intakes for Vitamin C, Vitamin E, full/pediatrics;115/2/496. have changed, and though nutrition
Selenium, and Carotenoids. Washington, DC: (18) Herman, DR. ‘‘Are economic science has advanced, the WIC
National Academy Press. incentives useful for improving dietary supplemental food packages have
(7) Institute of Medicine, National quality among WIC participants and their remained largely unchanged. A rule is
Academy of Sciences, 2001. Dietary families’’ Presentation at the public forum on
Reference Intakes for Vitamin A, Vitamin K, Impact of Changes in the WIC Food packages.
needed to implement recommended
Arsenic, Boron, Chromium, Copper, Iodine, Committee to Review the WIC Food changes to the WIC food packages based
Iron, Manganese, Molybdenum, Nickel, Packages, Institute of Medicine,. Los Angeles, on the current nutritional needs of WIC
Silicon, Vanadium, and Zinc. Washington, CA , July 22, 2004. participants and advances in nutrition
DC: National Academy Press. (19) Runnings, S. ‘‘Mother Infant and Child science.
(8) Institute of Medicine, National Harvest (MICH): Fruit and Vegetable Pilot Benefits. Benefits of this rule include
Academy of Sciences, 2002a. Dietary Program.’’ Presentation at the workshop on bringing the WIC food packages in line
Reference Intakes for Energy, Carbohydrate, Impact of Changes in the WIC Food Packages. with the 2005 Dietary Guidelines for
Fiber, Fat, Fatty Acids, Cholesterol, Protein, Committee to Review the WIC Food Americans and current infant feeding
and Amino Acids. Washington, DC: National Packages, Institute of Medicine. Los Angeles, practice guidelines of the American
Academy Press. CA, July 22, 2004.
(9) Institute of Medicine, National (20) U.S. Department of Agriculture,
Academy of Pediatrics, better promoting
Academy of Sciences, 2004. Dietary Agricultural Research Service. USDA and supporting the establishment of
Reference Intakes for Water, Potassium, Nutrient Database for Standard Reference, successful long-term breastfeeding,
Sodium, Chloride, and Sulfate. Washington, Release 17, 2004. Nutrient Data Laboratory providing WIC participants with a wider
DC: National Academies Press. Home Page at http://www.nal.usda.gov/fnic/ variety of food, providing WIC State
(10) USDA/FNS. WIC Participant and foodcomp/. agencies with greater flexibility in
Program Characteristics, 2002. Executive (21) Oliveira, V., Chandran, R. ‘‘Children’s prescribing food packages to
Summary. Available at Internet site: http:// Consumption of WIC-Approved Foods.’’
jlentini on PROD1PC65 with PROPOSAL2
accommodate participants with cultural
www.fns.usda.gov/oane/MENU/Published/ Food Assistance and Nutrition Research
WIC/FILES/PC2002ExecSum.pdf. Report No. 44. Available at Internet site:
food preferences, and serving all
(11) Institute of Medicine, National http://www.ers.usda.gov/publications/ participants with certain medical
Academy of Sciences, 2000. ‘‘Dietary fanrr44/fanrr44.pdf. conditions under one food package to
Reference Intakes: Applications in Dietary (22) Environmental Protection Agency/ facilitate efficient management of
Assessment.’’ National Academy Press. Food and Drug Administration. ‘‘What You medically fragile participants.
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44810 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
Costs. FNS estimates that the accommodate participants with cultural impact on small business. These
provisions in this proposed rule will food preferences. considerations include (among others)
have minimal impact on total costs over the establishment of differing
Description and Estimate of Number of
5 years. compliance or reporting requirements or
Small Entities to Which the Proposed
Regulatory Flexibility Act Rule Would Apply timetables that take into account the
resources available to small entities; the
This proposed rule has been reviewed This proposed rule would have a
clarification, consolidation, or
with regard to the requirements of the direct application only to WIC State
simplification of compliance and
Regulatory Flexibility Act of 1980 (5 agencies with respect to their selection
of foods to be included on their food reporting requirements under the rule
U.S.C. 601–612). Pursuant to that for small entities; the use of
review, Eric M. Bost, Under Secretary, lists. As a result, vendors and the food
industry would realize increased sales performance, rather than design,
Food, Nutrition and Consumer Services, standards; and an exemption from
has determined that this rule will not of some foods and decreases in other
foods, with an overall neutral effect on coverage of the rule, or any part thereof,
have a significant economic impact on
sales nationally. The rule may have an for small entities.
a substantial number of small entities.
State and local agencies and WIC indirect economic affect on certain In general, the alternatives of
recipients will be most affected by the small businesses because they may have exempting small entities from the
rule and WIC authorized vendors and to carry a larger variety of certain foods requirements proposed in this rule or
the food industry may be indirectly to be eligible for authorization as a WIC altering the requirements for small
affected. The proposed rule would vendor. Currently, approximately entities were rejected. The WIC food
provide State and local agencies with 45,000 stores are authorized to accept packages provide supplemental foods
increased flexibility in meeting food WIC food instruments, some of which
designed to address the nutritional
package requirements for the Program. are small businesses. With the high
needs of low-income pregnant,
Vendors and the food industry would degree of State flexibility allowable
under this proposed rule, small vendors breastfeeding, non-breastfeeding
realize increased sales of some foods postpartum women, infants and
and decreases in other foods, with an will be impacted differently in each
State depending upon how that State children up to age five who are at
overall neutral effect on sales nationally. nutritional risk. Exempting small
chooses to meet the proposed
Although not required by the requirements. It is therefore not feasible entities from providing the specific
Regulatory Flexibility Act, FNS has to accurately estimate the rule’s impact foods intended to address the
prepared an Initial Regulatory on small vendors. Since neither FNS nor nutritional needs of participants or
Flexibility Analysis (IRFA) describing the State agencies regulate food altering the requirements for small
the impact of this proposed rule on producers under the WIC program, it is entities would undermine the purpose
small entities. Written public comments not known how many small entities of the WIC Program and endanger the
are requested on this IRFA. Comments within that industry may be indirectly health status of participants.
must be identified as responses to the affected by the proposed rule. However,
IRFA and must be filed by the deadline FNS has, however, modified the new
such entities are encouraged to food provision in an effort to mitigate
for comments as provided in the Dates comment on this IRFA and the proposed
section. Additional analysis of the the impact on small entities. Currently,
rule and their comments will be State agencies must establish minimum
regulatory flexibility considerations of considered in the development of the
this proposed rule may be found in the requirements for the variety and
final rule.
Regulatory Impact Analysis section of quantity of foods that a vendor must
this preamble and the cited RIA itself. Description of Projected Reporting, stock in order to receive WIC Program
Recordkeeping, and Other Compliance authorization. This proposal would add
Need for, and Objectives of, the Requirements new food items, such as fruits and
Proposed Rule
This proposed rule provides State vegetables and whole grain breads,
This proposed rule would revise agencies with greater flexibility in which may require some WIC vendors,
regulations governing the WIC food prescribing food packages to WIC particularly smaller stores, to expand
packages to change the maximum participants. The information collection the types and quantities of food items
monthly allowances and minimum burden estimated for this proposal is stocked in order to maintain their WIC
requirements for certain supplemental 14,598 hours. The burden reflects authorization. In addition, vendors
foods, and add new foods such as fruits, requirements associated with medical would also have to make available more
vegetables and whole grains. The documentation for the issuance of any than one food type from each WIC food
revisions largely reflect supplemental foods issued to category, except for the categories of
recommendations made by the Institute participants who receive Food Package peanut butter and eggs, which may be
of Medicine of the National Academies III; any authorized soy-based beverage a change for some vendors. To mitigate
in its Report ‘‘WIC Food Packages: Time or tofu issued to children who receive the impact of the fruit and vegetable
for a Change’’. These revisions would Food Package IV; and, any additional requirement, the proposal allows
bring the WIC food packages in line authorized tofu and cheese issued to canned, frozen and dried fruits and
with the 2005 Dietary Guidelines for women who receive Food Packages V
Americans and current infant feeding vegetables to be substituted for fresh
and VII that exceeds the maximum produce.
practice guidelines of the American substitution rate.
Academy of Pediatrics, better promote Federal Rules That May Duplicate,
Steps Taken to Minimize Significant
jlentini on PROD1PC65 with PROPOSAL2
and support the establishment of Overlap, or Conflict With the Proposed
successful long-term breastfeeding, Economic Impact on Small Entities, and
Rule
provide WIC participants with a wider Significant Alternatives Considered
variety of food, and provide WIC State FNS has considered significant There are no federal rules that may
agencies with greater flexibility in alternatives in developing this proposed duplicate, overlap, or conflict with the
prescribing food packages to rule including those that may reduce provisions of this proposed rule.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44811
Public Law 104–4, Unfunded Mandates come from formal and informal packages (1983-present). NWA is a non-
Reform Act of 1995 (UMRA) discussions and with State and local profit organization that was founded in
Title II of the UMRA establishes officials on an ongoing basis regarding 1983 by State and local agencies that
requirements for Federal agencies to program implementation and food administer the WIC Program. As of June
assess the effects of their regulatory package policy issues, and from written 1, 2005, its paid membership included
actions on State, local, and tribal proposals and comments submitted to 73 of the 89 WIC State agencies, 675
governments and the private sector. FNS by WIC State and local agencies to local agencies, 4 State WIC
Under Section 202 of the UMRA, the allow modifications and/or Associations, and 18 sustaining
Department generally must prepare a substitutions to the WIC food packages. members (i.e., for-profit and non-profit
written statement, including a cost/ Requests for revisions to the WIC food businesses or organizations).
benefit analysis, for proposed and final packages have also been received from Functioning as a coalition of WIC
rules with ‘‘Federal mandates’’ that may Congress, participants, and agencies, NWA is dedicated to
result in expenditures to State, local, or organizations with interests in the maximizing WIC resources through
tribal governments, in the aggregate, or welfare of WIC participants. effective management practices. NWA
to the private sector, of $100 million or Examples of the different forums and also serves in a leadership role for WIC
more in any one year. When such a methods FNS has used over the years to agencies by developing position papers
statement is needed for a rule, section solicit WIC State and local agency staff on issues of concern to the WIC
205 of the UMRA generally requires the input on the WIC food packages include community.
Department to identify and consider a the following.
• Publishing an advanced notice of Nature of Concerns and the Need To
reasonable number of regulatory Issue This Rule
public rulemaking (ANPRM) in 2003 to
alternatives and adopt the least costly,
solicit comments to determine if the • Congress has requested a WIC food
more cost-effective or least burdensome
WIC food packages should be revised to package rule that includes fruits and
alternative that achieves the objectives
better improve the nutritional intake, vegetables and allows for cultural food
of the rule.
This proposed rule contains no health and development of participants; accommodations. Starting in fiscal year
Federal mandates (under the regulatory and, if so, what specific changes should 2001, Congress has directed the
provisions of Title II of the UMRA) that be made to the food packages. In Department, in language accompanying
impose costs on State, local, or tribal response to the ANPRM, FNS received WIC appropriations bills, to move
governments or to the private sector of 195 total comments; expeditiously to publish a proposed
• Commissioning the National
$100 million or more in any one year. food package rule for public comment;
Academies’ Institute of Medicine (IOM)
This rule is, therefore, not subject to the
to independently review the WIC Food • The National Advisory Council on
requirements of sections 202 and 205 of Maternal, Infant, and Fetal Nutrition, in
Packages. IOM solicited public
the UMRA. its 1992, 1996 and 2002 Reports to
comment on revisions to the WIC food
Executive Order 12372 packages, via 3 public hearings, letters Congress, recommended better
and e-mail, throughout its 22-month accommodation of the nutritional and
The Special Supplemental Nutrition cultural needs of WIC participants
Program for Women, Infants and study period. IOM considered these
comments, as well as comments the through the WIC food packages; and
Children (WIC) is listed in the Catalog • In 1999, NWA (then the National
of Federal Domestic Assistance under Department received in response to the
ANPRM, in developing Association of WIC Directors (NAWD))
No. 10.557. For reasons set forth in the published a position paper entitled
final rule in 7 CFR part 3015, Subpart recommendations to revise the WIC
food packages. IOM published its ‘‘NAWD WIC Food Prescription
V and related Notice (48 FR 29114, June
reports of these recommendations on Recommendations’’ (1) and in 2003,
24, 1983), this Program is included in
April 27, 2005: ‘‘WIC Food Packages: NWA published a position paper
the scope of Executive Order 12372,
Time for a Change.’’ (3) This proposed entitled ‘‘NWA WIC Culturally Sensitive
which requires intergovernmental
rule incorporates IOM?s Food Prescription Recommendations.’’
consultation with State and local (2) NWA’s major recommendations in
officials. recommendations;
• Holding nine public outreach these two reports were to reframe the
Federalism Summary Impact Statement sessions across the nation as part of WIC food packages to be consistent with
Executive Order 13132 requires FNS’ development of its 2004 the Dietary Guidelines for Americans
Federal agencies to consider the impact reauthorization proposals. Interested and allow State agencies flexibility to
of their regulatory actions on State and parties, including WIC State and local accommodate cultural eating patterns.
local governments. Where such actions staff, offered oral testimony and written Based upon the need to address the
have federalism implications, agencies statements on the WIC food packages as nutritional needs of the WIC population
are directed to provide a statement for well as on a variety of other WIC issues; given current scientific information and
inclusion in the preamble to the • Hosting annual meetings (1977- consumption patterns as exemplified by
regulations describing the agency’s present) of the National Advisory the concerns and recommendations of
considerations in terms of the three Council on Maternal, Infant and Fetal NWA, and others, FNS was aware of the
categories called for under section Nutrition that includes WIC staff as need to revise the WIC food packages.
(6)(b)(2)(B) of Executive Order 13132. members of the Council; the Council Extent to Which We Meet Those
develops recommendations for FNS on Concerns
Prior Consultation With WIC State and how to improve operations of the WIC
Local Agency Officials and Commodity Supplemental Food FNS has considered the impact of the
jlentini on PROD1PC65 with PROPOSAL2
Over the years the Department has Programs, including aspects related to proposed rule on State and local
received numerous requests from WIC the authorized foods and food packages; agencies. FNS believes that the
State and local agencies to modify the and recommendations in the IOM Report,
current food packages to permit greater • Consulting and collaborating with which are largely laid out in this
substitution of foods or introduction of NWA on a wide variety of WIC issues, proposed rule, are responsive to the
additional foods. These requests have including those related to the WIC food expressed concerns and requests of
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44812 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
commenters representing State and local accommodate WIC’s highly diverse whether the information will have
concerns. population. This proposed rule provides practical utility; (b) the accuracy of the
WIC State agencies with greater Agency’s estimate of the proposed
Executive Order 12988
flexibility in prescribing food packages information collection burden,
This rule has been reviewed under to accommodate participants with including the validity of the
Executive Order 12988, Civil Justice cultural food preferences, including methodology and assumptions used; (c)
Reform. This rule is intended to have allowing participants a broad selection ways to enhance the quality, utility and
preemptive effect with respect to any of fruits and vegetables; tofu and soy- clarity of the information to be
State or local laws, regulations or based beverages as substitutes for milk; collected; and, (d) ways to minimize the
policies which conflict with its participant choice for whole grains burden of the collection of information
provisions or which would otherwise (including tortillas); and salmon and on those who are to respond, including
impede its full implementation. This sardines as substitutions for tuna. This use of appropriate automated,
rule is not intended to have retroactive proposed rule also makes provisions to electronic, mechanical, or other
effect unless so specified in the DATES better accommodate the special dietary technological collection techniques or
paragraph of the preamble of the interim needs of high-risk participants served in other forms of information technology.
rule. Prior to any judicial challenge to Food Package III, helping to protect the All responses to this request for
the provisions of this rule or the health and well-being of this comments will be summarized and
application of its provisions, all nutritionally vulnerable subset of WIC included in the request for OMB
applicable administrative procedures participants. approval. All comments will also
must be exhausted.
Paperwork Reduction Act (60-Day become a matter of public record.
Civil Rights Impact Analysis Notice) Title: WIC Food Packages.
FNS has reviewed this proposed rule The Paperwork Reduction Act of 1995 OMB Number: Not Assigned.
in accordance with the Department (44 U.S.C. Chap. 35; see 5 CFR part Expiration Date: Not Yet Determined.
Regulation 4300–4, ‘‘Civil Rights Impact 1320) requires that OMB approve all Type of Request: New.
Analysis,’’ to identify and address any collections of information by a Federal Abstract: This rule proposes revisions
major civil rights impacts the rule might agency from the public before they can to the food packages to bring them in
have on minorities, women, and persons be implemented. Respondents are not line with the 2005 Dietary Guidelines
with disabilities. After a careful review required to respond to any collection of for Americans and current infant
of the rule’s intent and provisions, and information unless it displays a current feeding practice guidelines of the
the characteristics of WIC Program valid OMB control number. This American Academy of Pediatrics. The
applicants and participants, FNS has proposed rule contains information revisions would also: better promote
determined that it does not have a collections that are subject to review and support the establishment of
deleterious effect on the participation of and approval by OMB; therefore, FNS successful long-term breastfeeding,
protected individuals in the WIC has submitted an information collection provide WIC participants with a wider
Program. All data available to FNS which contains the changes in burden variety of foods, provide WIC State
indicate that protected individuals have from adoption of the proposals in the agencies with greater flexibility in
the same opportunity to participate in rule, for OMB’s review and approval. prescribing food packages to
the WIC Program as non-protected Comments on the information accommodate participants with cultural
individuals. FNS specifically prohibits collection in this proposed rule must be preferences, and serve participants with
State and local agencies operating the received by October 6, 2006. certain qualifying conditions under one
WIC Program from discrimination based Send comments to the Office of food package to facilitate efficient
on race, color, national origin, sex, age, Information and Regulatory Affairs, management of medically fragile
or disability. Section 246.8(a) of WIC OMB, Attention: Desk Officer for FNS, participants.
regulations requires State agencies to Washington, DC, 20503. Please also The average burden per response and
ensure that no person will be excluded send a copy of your comments to the annual burden hours are explained
from participation based on race, color, Patricia N. Daniels, Director, below and summarized in the chart
national origin, age, sex or disability. Supplemental Food Programs Division, which follows.
Where State agencies have options, and Food and Nutrition Service, U.S.
Respondents for this Rule: Individuals
they choose to implement a certain Department of Agriculture, 3101 Park
or households and State, Local or Tribal
provision, they must implement it in Center Drive, Room 528, Alexandria,
Governments.
such a way that it complies with the Virginia 22302. For further information,
regulations at § 246.8. or for copies of the information Estimated Number of Respondents:
This rule merely addresses revisions collection requirements, please contact 152,783.
to the WIC food packages to bring them Debra Whitford at the address indicated Estimated Number of Responses per
into line with the DGA 2005 (12) and above. Respondent: 2.
current infant feeding recommendations Comments are invited on (a) whether Estimate Average Hours per
from the American Academy of the proposed collection of information Response: 0.05.
Pediatrics. Several provisions are is necessary for the proper performance Estimated Total Annual Burden on
specifically designed to better of the Agency’s functions, including Respondents: 14,598 Hours.
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
jlentini on PROD1PC65 with PROPOSAL2
Number
Annual number Average burden Annual burden
Section of regulations responses per
of respondents per response hours
respondent
Reporting Burden:
§ 246.10(d) ................................................................................ 142,783 2 0.05 14,728
Recordkeeping Burden:
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44813
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued
Number
Annual number Average burden Annual burden
Section of regulations responses per
of respondents per response hours
respondent
§ 246.10(d) ................................................................................ 10,000 2 0.016 320
Total Reporting and Recordkeeping Burden in the Pro-
posed Rule ..................................................................... 152,783 2 0.05 14,598
1. Reporting technologies to provide increased serve the purpose of a food, meal or diet
Sections 246.10(d) would require opportunities for citizen access to (may be nutritionally complete or
medical documentation for the issuance Government information and services, incomplete) and provide a source of
of any supplemental foods issued to and for other purposes. calories and one or more nutrients; be
participants who receive Food Package designed for enteral digestion via an
List of Subjects in 7 CFR Part 246
III; any authorized soy-based beverage oral or tube feeding; and may not be a
Administrative practice and conventional food, drug, flavoring, or
or tofu issued to children who receive procedure, Civil rights, Food assistance
Food Package IV; and, any additional enzyme.* * *
programs, Grant programs—health, 3. Revise § 246.10 to read as follows:
authorized tofu and cheese issued to Grant programs—social programs,
women who receive Food Packages V Indians, Infants and children, Maternal § 246.10 Supplemental foods.
and VII that exceeds the maximum and child health, Nutrition, Penalties, (a) General. This section prescribes
substitution rate. Reporting and recordkeeping the requirements for providing
In addition, the content of the medical requirements, Women. supplemental foods to participants. The
documentation would be expanded to State agency must ensure that local
For reasons set forth in the preamble,
include: (1) Contact information for the agencies comply with this section.
7 CFR part 246 is proposed to be
participant’s healthcare provider (b) State agency responsibilities. (1)
amended as follows:
making the medical determination; (2) State agencies may:
date of medical determination; (3) the PART 246—SPECIAL SUPPLEMENTAL (i) Establish criteria in addition to the
specific supplemental foods to be NUTRITION PROGRAM FOR WOMEN, minimum Federal requirements in Table
prescribed; (4) amount prescribed per INFANTS AND CHILDREN 4 of paragraph (e)(12) of this section for
day; (5) the medical determination of the supplemental foods in their States.
the qualifying conditions which 1. The authority citation for part 246 These State criteria could address, but
warrants the supplemental foods; and continues to read as follows: not be limited to, other nutritional
(6) the length of time the supplemental Authority: 42 U.S.C. 1786. standards, competitive cost, State-wide
foods is medically required. 2. In § 246.2: availability, and participant appeal; and
FNS estimates that approximately 1 a. Revise the definition of (ii) Make food package adjustments to
percent of participants (86,375) will be ‘‘Participation’’; and better accommodate participants who
issued supplemental foods under Food b. Amend the definition of ‘‘WIC- are homeless. At the State agency’s
Package III; 1 percent of children eligible medical foods’’ by removing the option, these adjustments would
(42,408) will be authorized soy-based words ‘‘for individuals with a diagnosed include, but not be limited to, issuing
beverage or tofu under Food Package IV; medical condition’’ and adding in their authorized supplemental foods in
and, 1 percent of women (14,000) will place the words ‘‘for women or children individual serving-size containers to
be authorized tofu and cheese in excess with a qualifying condition’’, and by accommodate lack of food storage or
of the maximum substitution rate under revising the second sentence. preparation facilities.
Food Packages V and VII. Further, FNS The revisions read as follows: (2) State agencies must:
estimates that it will take three minutes (i) Identify the brands of foods and
(0.05 person hours) for the § 246.2 Definitions. package sizes that are acceptable for use
documentation required to issue the * * * * * in the Program in their States in
authorized foods. Thus, the estimated Participation means the sum of: accordance with the requirements of
reporting burden is 14,278 (142,783 (1) The number of persons who this section. State agencies must also
total participants × 0.05 person hours × received supplemental foods or food provide to local agencies a list of
2 certification periods per year). instruments during the reporting period; acceptable foods and their maximum
(2) The number of infants who did not monthly allowances as specified in
2. Recordkeeping receive supplemental foods or food Tables 1 through 3 of paragraphs (e)(9)
FNS estimates that it will take one instruments but whose breastfeeding through (e)(11) of this section; and
minute (0.016 per record) for each clinic mother received supplemental foods or (ii) Ensure that local agencies:
(10,000 clinics) to file the required food instruments during the report (A) Make available to participants the
medical documentation provided by period; and maximum monthly allowances of
participants, for an estimated burden of (3) The number of breastfeeding authorized supplemental foods, except
320 hours (10,000 clinics × 0.016 hours women who did not receive as noted in paragraph (c) of this section,
per record × 2 times per year). supplemental foods or food instruments and abide by the authorized substitution
jlentini on PROD1PC65 with PROPOSAL2
but whose infant received supplemental rates for WIC food substitutions as
E-Government Act Compliance foods or food instruments during the specified in Tables 1 through 3 of
The Food and Nutrition Service is report period. paragraphs (e)(9) through (e)(11) of this
committed to complying with the * * * * * section;
E-Government Act to promote the use of WIC-eligible medical foods * * * (B) Make available to participants
the Internet and other information Such WIC-eligible medical foods must more than one food from each WIC food
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44814 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
category except for the categories of is required for the issuance of the (ii) Content. All medical
peanut butter and eggs, and at least two following supplemental foods: documentation must include the
fruits and two vegetables from the (i) Any non-contract brand infant following:
category of fruits and vegetables (fresh formula; (A) The name of the authorized WIC
or processed) in each authorized food (ii) Any infant formula prescribed to formula (infant formula, exempt infant
package as listed in paragraph (e) of this a child or adult who receives Food formula, WIC-eligible medical food)
section; Package III; prescribed, including amount needed
(C) Authorize only a competent (iii) Any exempt infant formula; per day;
professional authority to prescribe the (iv) Any WIC-eligible medical food; (B) The authorized supplemental
categories of authorized supplemental (v) Any authorized supplemental food food(s) appropriate for the qualifying
foods in quantities that do not exceed issued to participants who receive Food condition(s) and their prescribed
the regulatory maximum and are Package III; amounts;
appropriate for the participant, taking (vi) Any authorized soy-based (C) Length of time the prescribed WIC
into consideration the participant’s age formula and/or supplemental food is
beverage or tofu issued to children who
and nutritional needs; and required by the participant;
receive Food Package IV;
(D) Advise participants or their (D) The qualifying condition(s) for
(vii) Any additional authorized cheese issuance of the authorized supplemental
caretaker, when appropriate, that the issued to children who receive Food
supplemental foods issued are only for food(s) requiring medical
Package IV that exceeds the maximum documentation, as described in
their personal use. However, the substitution rate;
supplemental foods are not authorized paragraphs (e)(3) through (e)(7) of this
(viii) Any additional authorized tofu section; and
for participant use while hospitalized
and cheese issued to women who (E) Signature, date and contact
on an in-patient basis. In addition,
receive Food Packages V and VII that information (or name, date and contact
consistent with § 246.7(n)(1)(i)(B),
exceeds the maximum substitution rate; information), if the initial medical
supplemental foods are not authorized
and documentation was received by
for use in the preparation of meals
(ix) Any contract brand infant formula telephone and the signed document is
served in a communal food service. This
that does not meet the requirements in forthcoming, of the health care
restriction does not preclude the
Table 4 of paragraph (e)(12) of this professional licensed by the State to
provision or use of supplemental foods
section. write prescriptions in accordance with
for individual participants in a
(2) Supplemental foods not requiring State laws.
nonresidential setting (e.g., child care
medical documentation. (i) State (iii) Written confirmation—(A)
facility, family day care home, school,
agencies may authorize local agencies to General. Medical documentation must
or other educational program); a
issue a non-contract brand infant be written and may be provided as an
homeless facility that meets the
formula that meets the requirements in original written document, an electronic
requirements of § 246.7(n)(1); or, at the
Table 4 of paragraph (e)(12) of this document, by facsimile or by telephone
State agency’s discretion, a residential
section without medical documentation to a competent professional authority
institution (e.g., home for pregnant
in order to meet religious eating until written confirmation is received.
teens, prison, or residential drug
patterns; and (B) Medical documentation provided
treatment center) that meets the
requirements currently set forth in (ii) The State agency has the by telephone. Medical documentation
§ 246.7(n)(1) and (n)(2). discretion to require medical may be provided by telephone to a
(c) Nutrition tailoring. The full documentation for any contract brand competent professional authority who
maximum monthly allowances of all infant formula and may decide that must promptly document the
supplemental foods in all food packages some contract brand infant formula may information. The collection of the
must be made available to participants not be issued under any circumstances. required information by telephone for
if medically or nutritionally warranted. (3) Medical Determination. For medical documentation purposes may
Reductions in these amounts cannot be purposes of this program, medical only be used until written confirmation
made for cost-savings, administrative documentation means that a health care is received from a health care
convenience, caseload management, or professional licensed to write medical professional licensed to write medical
to control vendor abuse. Reductions in prescriptions under State law has: prescriptions and used only when
these amounts cannot be made for (i) Made a medical determination that absolutely necessary on an individual
categories, groups or subgroups of WIC the participant has a qualifying participant basis. The local clinic must
participants. The provision of less than condition as described in paragraphs obtain written confirmation of the
the maximum monthly allowances of (e)(3) through (e)(7) of this section that medical documentation within a
supplemental foods to an individual dictates the use of the supplemental reasonable amount of time (i.e., one or
WIC participant in all food packages is foods, as described in paragraph (d)(1) two week’s time) after accepting the
appropriate only when: of this section; and initial medical documentation by
(1) Medically or nutritionally (ii) Provided the written telephone.
warranted (e.g., to eliminate a food due documentation that meets the technical (5) Medical supervision requirements.
to a food allergy); requirements described in paragraphs Due to the nature of the health
(2) A participant refuses or cannot use (d)(4)(ii) and (d)(4)(iii) of this section. conditions of participants who are
the maximum monthly allowances; or (4) Technical Requirements—(i) issued supplemental foods that require
(3) The quantities necessary to Location. All medical documentation medical documentation, close medical
supplement another programs’ must be kept on file (electronic or hard supervision is essential for each
jlentini on PROD1PC65 with PROPOSAL2
contribution to fill a medical copy) at the local clinic. The medical participant’s dietary management. The
prescription would be less than the documentation kept on file must responsibility remains with the
maximum monthly allowances. include the initial telephone participant’s health care provider for
(d) Medical documentation—(1) documentation, when received as this medical oversight and instruction.
Supplemental foods requiring medical described in paragraph (d)(4)(iii)(B) of This responsibility cannot be assumed
documentation. Medical documentation this section. by personnel at the WIC State or local
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44815
agency. However, it would be the (A) The participant’s household has life threatening disorders, diseases and
responsibility of the WIC competent an unsanitary or restricted water supply medical conditions that impair
professional authority to ensure that or poor refrigeration; ingestion, digestion, absorption or the
only the amounts of supplemental foods (B) The person caring for the utilization of nutrients that could
prescribed by the participant’s health participant may have difficulty in adversely affect the participant’s
care provider are issued in the correctly diluting concentrated or nutrition status. This food package may
participant?s food package. powder forms; or not be issued solely for the purpose of
(e) Food packages. There are seven (C) The WIC infant formula is only enhancing nutrient intake or managing
food packages available under the available in ready-to-feed. body weight.
Program that may be provided to (v) Authorized category of (ii) Non-authorized issuance of Food
participants. The authorized supplemental foods. Infant formula is Package III. This food package is not
supplemental foods must be prescribed the only category of supplemental foods authorized for:
from food packages according to the authorized in this food package. Exempt (A) Infants whose only condition is:
category and nutritional needs of the infant formulas and WIC-eligible (1) A diagnosed formula intolerance
participant. The food packages are as medical foods are authorized only in or food allergy to lactose, sucrose, milk
follows: Food Package III. protein or soy protein that does not
(1) Food Package I—Infants birth (2) Food Package II—Infants 6 require the use of an exempt infant
through 5 months—(i) Participant through 11 months—(i) Participant formula ; or
category served. This food package is category served. This food package is (2) A non-specific formula or food
designed for issuance to infant designed for issuance to infant intolerance.
participants from birth through age 5 participants from 6 through 11 months (B) Women and children who have a
months who do not have a condition of age who do not have a condition food intolerance to lactose or milk
qualifying them to receive Food Package qualifying them to receive Food Package protein that can be successfully
III. III. managed with the use of one of the
(ii) Infant feeding categories—(A) (ii) Infant feeding options. Three other WIC food packages (i.e., Food
Birth through one month. Two infant infant feeding options are available— Packages IV–VII); or
feeding options are available during the fully breastfeeding, fully formula- (C) Any participant solely for the
first month after birth—fully feeding, or partially breastfeeding. purpose of enhancing nutrient intake or
breastfeeding, i.e., the infant receives no (iii) Infant formula requirements. The managing body weight without an
infant formula from the WIC Program, or requirements for issuance of infant underlying qualifying condition.
fully formula-feeding. Infant formula is formula in Food Package I, specified in (iii) Restrictions on the issuance of
not provided during the first month paragraphs (e)(1)(iii) and (e)(1)(iv) of WIC formulas in ready-to-feed (RTF)
after birth to fully breastfed infants to this section, also apply to the issuance forms. WIC State agencies must issue
support the successful establishment of of infant formula in Food Package II. WIC formulas (infant formula, exempt
breastfeeding. (iv) Authorized categories of infant formula and WIC-eligible medical
(B) Two through 5 months. Three supplemental foods. Infant formula, foods) in concentrated liquid or powder
infant feeding options are available from infant fruits and vegetables, infant meat, physical forms unless the requirements
2 months through 5 months—fully and infant cereal are the categories of for issuing RTF are met as described in
breastfeeding, fully formula-feeding, or supplemental foods authorized in this paragraph (e)(1)(iv) of this section. In
partially breastfeeding, i.e., the infant is food package. addition to those requirements, there are
breastfed but also receives infant (3) Food Package III—Participants two additional conditions which may be
formula from the WIC Program in an with qualifying conditions—(i) used to issue RTF in Food Package III:
amount not to exceed approximately Participant category served and (A) If a ready-to-feed form better
half the amount of infant formula qualifying conditions. This food package accommodates the participant’s
allowed for a fully formula fed infant. is reserved for issuance to women, condition; or
(iii) Infant formula requirements. This infants and child participants who have (B) If it improves the participant’s
food package provides iron-fortified a documented qualifying condition that compliance in consuming the
infant formula that is not an exempt requires the use of a WIC formula prescribed WIC formula.
infant formula. The issuance of any (infant formula, exempt infant formula (iv) Unauthorized WIC costs. All
contract brand or noncontract brand or WIC-eligible medical food) because apparatus or devices (e.g., enteral
infant formula that contains less than 10 the use of conventional foods is feeding tubes, bags and pumps)
milligrams of iron per liter at standard precluded, restricted, or inadequate to designed to administer WIC formulas
dilution (i.e., approximately 20 address their special nutritional needs. are not allowable WIC costs.
kilocalories per fluid ounce of prepared Medical documentation must meet the (v) Authorized categories of
formula) is prohibited. Except as requirements described in paragraph (d) supplemental foods. The supplemental
specified in paragraph (d) of this of this section. Participants who are foods authorized in this food package
section, local agencies must issue a eligible to receive this food package require medical documentation for
contract brand infant formula that meets must have one or more qualifying issuance and include infant formula (for
the requirements in Table 4 of conditions, as determined by a health children or women), exempt infant
paragraph (e)(12) of this section. care professional licensed to write formula, WIC-eligible medical foods (for
(iv) Physical forms. Local agencies medical prescriptions under State law. children and women), infant cereal,
must issue all WIC formulas (WIC The qualifying conditions include but infant food fruits and vegetables, milk
formulas mean all infant formula, are not limited to premature birth, low and milk alternatives, cheese, eggs,
jlentini on PROD1PC65 with PROPOSAL2
exempt infant formula and WIC-eligible birth weight, failure to thrive, inborn canned fish, fruits and vegetables,
medical foods) in concentrated liquid or errors of metabolism and metabolic breakfast cereal, whole wheat bread or
powder physical forms. Ready-to-feed disorders, gastrointestinal disorders, other whole grains, juice, legumes and/
WIC formulas may be authorized when malabsorption syndromes, immune or peanut butter.
the competent professional authority system disorders, severe food allergies (vi) Coordination with medical payors
determines and documents that: that require an elemental formula, and and other programs that provide or
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44816 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
reimburse for formulas. WIC State women participants with singleton exceeding the maximum substitution
agencies must coordinate with other pregnancies who do not have a allowances may be allowed with
Federal, State or local government condition qualifying them to receive medical documentation of the
agencies or with private agencies that Food Package III. This food package is qualifying condition, up to the
operate programs that also provide or also designed for issuance to maximum allowance for fluid milk. A
could reimburse for exempt infant breastfeeding women participants, up to health care professional licensed by the
formulas and WIC-eligible medical 1 year postpartum, who do not have a State to write prescriptions must make
foods benefits to mutual participants. At condition qualifying them to receive a medical determination and provide
a minimum, a WIC State agency must Food Package III and whose partially medical documentation that a woman
coordinate with the State Medicaid breastfed infants receive formula from cannot drink milk and requires
Program for the provision of exempt the WIC program in amounts that do not additional cheese or calcium-set tofu.
infant formulas and WIC-eligible exceed the maximum allowances Such determination can be made for
medical foods that are authorized or described in Table 1 of paragraph (e)(9) situations that include, but are not
could be authorized under the State of this section. Women participants limited to, milk allergy or severe lactose
Medicaid Program for reimbursement breastfeeding more than one infant, and maldigestion. Medical documentation
and that are prescribed for WIC women participants pregnant with more must meet the requirements described
participants who are also Medicaid than one fetus, are eligible to receive in paragraph (d) of this section.
recipients. The WIC State agency is Food Package VII as described in (7) Food Package VII—Fully
responsible for providing up to the paragraph (e)(7) of this section. breastfeeding (enhanced)—(i)
maximum amount of exempt infant (ii) Authorized categories of Participant category served. This food
formulas and WIC-eligible medical supplemental foods. Milk, breakfast package is designed for issuance to
foods under Food Package III in cereal, juice, fruits and vegetables, breastfeeding women up to 1 year
situations where reimbursement is not whole wheat bread or other whole postpartum whose infants do not
provided by another entity. grains, eggs, legumes and peanut butter receive infant formula from WIC (these
(4) Food Package IV—Children 1 are the categories of supplemental foods breastfeeding women are assumed to be
through 4 years—(i) Participant category authorized in this food package. Cheese fully breastfeeding their infants), and to
served. This food package is designed or calcium-set tofu may be substituted all breastfeeding women during the first
for issuance to participants 1 through 4 for milk in amounts described in Table month postpartum. This food package is
years of age who do not have a 2 of paragraph (e)(10) of this section. also designed for issuance to women
condition qualifying them to receive Amounts of cheese or calcium-set tofu participants pregnant with two or more
Food Package III. exceeding the maximum substitution fetuses, and women participants
(ii) Authorized categories of allowances may be allowed with partially breastfeeding multiple infants.
supplemental foods. Milk, breakfast medical documentation of the Women participants fully breastfeeding
cereal, juice, fruits and vegetables, qualifying condition, up to the multiple infants receive 1.5 times the
whole wheat bread or other whole maximum allowance for fluid milk. A supplemental foods provided in Food
grains, eggs, and legumes or peanut health care professional licensed by the Package VII.
butter are the categories of supplemental State to write prescriptions must make (ii) Authorized categories of
foods authorized in this food package. a medical determination and provide supplemental foods. Milk, cheese,
Cheese may be substituted for milk in medical documentation that a woman breakfast cereal, juice, fruits and
amounts described in Table 2 of cannot drink milk and requires vegetables, whole wheat bread or other
paragraph (e)(10) of this section. additional cheese or calcium-set tofu. whole grains, eggs, legumes, peanut
Substitutions exceeding the maximum Such determination can be made for butter, and canned fish are the
substitution allowance of cheese, up to situations that include, but are not categories of supplemental foods
the maximum allowance for fluid milk, limited to, milk allergy or severe lactose authorized in this food package. Cheese
may be allowed with medical maldigestion. Medical documentation or calcium-set tofu may be substituted
documentation of the qualifying must meet the requirements described for milk in amounts described in Table
condition. Soy-based beverages and tofu in paragraph (d) of this section. 2 of paragraph (e)(10) of this section.
can be substituted for milk only with (6) Food Package VI—Postpartum Amounts of cheese or calcium-set tofu
medical documentation in this food women—(i) Participant category served. exceeding the maximum substitution
package, in amounts described in Table This food package is designed for allowances may be allowed with
2 of paragraph (e)(10) of this section. A issuance to women up to 6 months medical documentation of the
health care professional licensed by the postpartum who are not breastfeeding qualifying condition, up to the
State to write prescriptions must make their infants, and to breastfeeding maximum allowance for fluid milk. A
a medical determination and provide women up to 6 months postpartum health care professional licensed by the
medical documentation that a child whose participating infant receives State to write prescriptions must make
cannot drink milk and requires soy- more than the maximum amount of a medical determination and provide
based beverage, tofu, or additional formula allowed for partially breastfed medical documentation that a woman
cheese as a substitute for milk. Such infants as described in Table 1 of cannot drink milk and requires
determination can be made for paragraph (e)(9) of this section. additional cheese or calcium-set tofu.
situations that include, but are not (ii) Authorized categories of Such determination can be made for
limited to, milk allergy, severe lactose supplemental foods. Milk, breakfast situations that include, but are not
maldigestion, and vegan diets. Medical cereal, juice, fruits and vegetables, eggs, limited to, milk allergy or severe lactose
documentation must meet the and legumes or peanut butter are the maldigestion. Medical documentation
jlentini on PROD1PC65 with PROPOSAL2
requirements described in paragraph (d) categories of supplemental foods must meet the requirements described
of this section. authorized in this food package. Cheese in paragraph (d) of this section.
(5) Food Package V—Pregnant and or calcium-set tofu may be substituted (8) Supplemental Foods—Maximum
partially breastfeeding women—(i) for milk in amounts described in Table monthly allowances, options and
Participant category served. This food 2 of paragraph (e)(10) of this section. substitution rates, and minimum
package is designed for issuance to Amounts of cheese or calcium-set tofu requirements. Tables 1 through 3 of
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44817
paragraphs (e)(9) through (e)(11) of this describes the minimum requirements and substitution rates of supplemental
section specify the maximum monthly and specifications of supplemental foods for infants in Food Packages I, II
allowances of foods in WIC food foods in the WIC food packages. and III are stated in Table 1 as follows:
packages and identify WIC food options (9) Maximum monthly allowances of
and substitution rates. Table 4 of supplemental foods for infants. The
paragraph (e)(12) of this section maximum monthly allowances, options
TABLE 1.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR INFANTS IN FOOD PACKAGES I, II AND III
Fully formula fed (FF) Partially breastfed Fully breastfed (BF)
(BF/FF)
Food packages I– Food packages I–
FF & III–FF Food packages II– Food packages II– Food package I– Food package
Foods 1 BF/FF & III BF/FF
A: 0 through 3 FF & III–FF BF/FF & III BF/FF BF II–BF & III BF
A: 1 through 3
months 6 through 11 6 through 11 0 through 5 6 through 11
months 2
B: 4 through 5 months B: 4 through 5 months months months
months months
Infant formula 3 4 5 6 A: 806 fl. oz. re- 624 fl. oz. reconsti- A: 364 fl. oz. re- 312 fl. oz. reconsti-
and Exempt In- constituted liquid tuted liquid con- constituted liquid tuted liquid con-
fant formula. concentrate or centrate or 640 concentrate or centrate or 320
800 fl. oz. RTF fl. oz. RTF or. 364 fl. oz. RTF fl. oz. RTF or.
or 870 fl. oz. re- or 435 fl. oz. re-
constituted pow- constituted pow-
der. der.
B: 884 fl. oz. re- 696 fl. oz. reconsti- B: 442 fl. oz. re- 384 fl. oz. reconsti-
constituted liquid tuted powder. constituted liquid tuted powder.
concentrate or concentrate or
896 fl. oz. RTF 448 fl. oz. RTF
or 960 fl. oz. re- or 522 fl. oz. re-
constituted pow- constituted pow-
der. der.
Infant cereal 7 ......... ............................... 24 oz ..................... ............................... 24 oz ..................... ........................... 24 oz.
Infant food 7 8 fruits ............................... 128 oz ................... ............................... 128 oz ................... ........................... 256 oz.
and vegetables 77.5 oz.
Infant food meat.
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).
1 Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods.
2 The powder form is the form recommended for partially breastfed infants, ages 1 through 3 months in Food Package I.
3 The 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.
4 Only infant formula may be issued for infants in Food Packages I and II. Exempt infant formula may only be issued for infants in Food Pack-
age III.
5 If powder infant formula is provided, State agencies must provide at least the number of reconstituted fluid ounces as the maximum allow-
ance 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.
6 State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to re-
ceive the full authorized nutritional benefit (FNB). State agencies must use the methodology described in accordance with paragraph (h)(1) of
this section.
7 State agencies may round up and disperse whole containers of infant foods (infant cereal, fruits and vegetables, and meat) over the Food
Package timeframe. .State agencies must use the methodology described in accordance with paragraph (h)(2) of this section.
8 Fresh 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 allowances, options and substitution and women in Food Package IV through
supplemental foods in Food Packages rates of supplemental foods for children VII are stated in Table 2 as follows:
IV through VII. The maximum monthly
TABLE 2.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGES
IV, V, VI AND VII
Children Women
Foods 1 Food package V: Pregnant Food package VI: Food package VII: Fully
Food package IV: 1 breastfeeding (enhanced),
and partially breastfeeding Postpartum (up to 6
through 4 years (up to 1 year post-
(up to 1 year postpartum) 2 months postpartum) 3
partum) 4 5
jlentini on PROD1PC65 with PROPOSAL2
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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44818 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 2.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGES
IV, V, VI AND VII—Continued
Children Women
Food package VII: Fully
Foods 1 Food package V: Pregnant Food package VI:
Food package IV: 1 breastfeeding (enhanced),
and partially breastfeeding Postpartum (up to 6
through 4 years (up to 1 year post-
(up to 1 year postpartum) 2 months postpartum) 3 partum) 4 5
Fruits and vegetables 13 14 $6.00 in cash value vouch- $8.00 in cash value vouch- $8.00 in cash value vouch- $8.00 in cash value vouch-
ers. ers. ers. ers.
Whole wheat bread or 2 lb .................................... 1 lb .................................... N/A .................................... 1 lb.
other whole grains 15.
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.
1 Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods.
2 Food 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.
3 Food 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.
4 Food 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 par-
tially breastfeeding multiple infants.
5 Women 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 month-
ly allowance for single-strength juice.
7 Whole 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.
8 Evaporated 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 sub-
stitution 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.
9 For 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 quali-
fying conditions, up to the maximum allowance for fluid milk.
10 For 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.
11 For 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 sub-
stituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other qualifying conditions.
12 For 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.
13 Processed (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.
14 The maximum value of the vouchers may be adjusted in whole dollar increments to reflect accrued annual, un-rounded inflationary in-
creases.
15 Brown 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 but-
ter); 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 Food Package III. The maximum for participants with qualifying
supplemental foods for children and monthly allowances, options and conditions in Food Package III are stated
women with qualifying conditions in substitution rates of supplemental foods in Table 3 as follows:
TABLE 3.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGE
III
Children Women
Foods 1 Pregnant and partially Fully breastfeeding (en-
Postpartum (up to 6
1 through 4 years breastfeeding (up to 1 year hanced), (up to 1 year
months postpartum) 3
postpartum) 2 post-partum) 4 5
jlentini on PROD1PC65 with PROPOSAL2
Juice, single strength 6 ...... 128 fl. oz ........................... 144 fl. oz ........................... 96 fl. oz ............................. 144 fl. oz.
WIC Formula 7 8 ................. 455 fl. oz. liquid con- 455 fl. oz. liquid con- 455 fl. oz. liquid con- 455 fl. oz. liquid con-
centrate. centrate. centrate. centrate.
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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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44819
TABLE 3.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGE
III—Continued
Children Women
Foods 1 Pregnant and partially Postpartum (up to 6 Fully breastfeeding (en-
1 through 4 years breastfeeding (up to 1 year months postpartum) 3 hanced), (up to 1 year
postpartum) 2 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 vouch- $8.00 in cash value vouch- $8.00 in cash value vouch- $8.00 in cash value vouch-
er. ers. ers. ers.
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
1 Table 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.
5 Women 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 month-
ly allowance for single-strength juice.
7 WIC formula means infant formula, exempt infant formula, or WIC-eligible medical food.
8 Powder and Ready-to-Feed may be substituted at rates that provide comparable nutritive value.
9 Whole 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.
10 Evaporated 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.
11 For 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 quali-
fying conditions, up to the maximum allowance for fluid milk.
12 For 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.
13 For 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 sub-
stituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other qualifying conditions.
14 For 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.
16 Processed (canned, frozen, dried) fruits and vegetables may be substituted for fresh fruits and vegetables. Dried fruit and dried vegetables
are not authorized for children.
17 The maximum value of the vouchers may be adjusted in whole dollar increments to reflect accrued annual, un-rounded inflationary in-
creases.
18 Brown 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 Table 4 describes the minimum supplemental foods in all food
specifications for supplemental foods. requirements and specifications for 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
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201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and meet the re-
quirements 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 dilu-
tion;
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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 ex-
empt 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 pre-
cluded, restricted or inadequate;
(2) must serve the purpose of a food, meal or diet (may be nutritionally complete or incom-
plete) 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, evapo-
rated (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 cho-
lesterol 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 vi-
tamin 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-ap-
proved juices. Juices that are fortified with other nutrients may be allowed at the State agen-
cy’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.
jlentini on PROD1PC65 with PROPOSAL2
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); includ-
ing applesauce; juice pack or water pack without added sugars, fats, oils, or salt (i.e., so-
dium). Any variety of frozen fruits without added sugars.7
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44821
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); with-
out 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., so-
dium).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 agen-
cy’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 so-
dium 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 len-
tils. All categories exclude soups. May not contain added sugars, fats, oils or meat as pur-
chased. 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 al-
lowed.
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 in-
gredient. 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.
1 The 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 rehydra-
tion fluids or electrolyte solutions; flavoring or thickening agents; and feeding utensils or devices (e.g., feeding tubes, bags, pumps) designed to
administer a WIC-eligible formula.
2 All authorized milks must 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 lactose-
free, 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.
3 Any 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 so-
dium 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.
4 Food 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.
7 Excludes white potatoes; catsup or other condiments; pickled vegetables, olives; soups; juices; and fruit leathers and fruit roll-ups.
jlentini on PROD1PC65 with PROPOSAL2
8 The 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 (C) Disperse the number of whole containers to be issued during the
foods. (1) At the request of a State containers as evenly as possible over the timeframe that the food package is
agency, the Department may purchase timeframe (the number of months the prescribed.
commodity foods for the State agency participant will receive the food (C) If the number of containers to be
using funds allocated to the State package). issued does not result in a whole
agency. The commodity foods (ii) The methodology to calculate number of containers, the State agency
purchased and made available to the rounding up and dispersing infant must round up to the next whole
State agency must be equivalent to the formula to the next whole container container in order to issue whole
foods specified in Table 4 of paragraph over the food package timeframe is as containers.
(e)(12) of this section. follows: In § 246.12, paragraph (g)(3)(i) is
(2) The State agency must: (A) Multiply the FNB amount for the revised to read as follows:
(i) Distribute the commodity foods to appropriate food package and feeding
§ 246.12 Food delivery systems.
its local agencies or participants; and option (e.g. Food Package I A fully
(ii) Ensure satisfactory storage formula fed, IA–FF) by the timeframe * * * * *
facilities and conditions for the the participant will receive the food (g) * * *
commodity foods, including (3) * * *
package to determine the total amount
(i) Minimum variety and quantity of
documentation of proper insurance. of infant formula to be provided. The
(g) Infant formula manufacturer supplemental foods. The State agency
timeframe will vary depending on the
registration. Infant formula must establish minimum requirements
food package category and infant
manufacturers supplying formula to the for the variety and quantity of
feeding option.
WIC Program must be registered with supplemental foods that a vendor
(B) Divide the total amount of infant
the Secretary of Health and Human applicant must stock to be authorized.
formula provided by the yield of the
Services under the Federal Food, Drug, These requirements must include that
container (in reconstituted fluid ounces)
and Cosmetic Act (21 U.S.C. 301 et the vendor stock at least two varieties of
issued by the State agency to determine
seq.). Such manufacturers wishing to fruits and vegetables authorized by the
the total number of containers to be
bid for a State contract to supply infant State agency. The State agency may not
issued during the timeframe that the
formula to the program must certify authorize a vendor applicant unless it
food package is prescribed.
with the State health department that determines that the vendor applicant
(C) If the number of containers to be
their formulas comply with the Federal meets these minimums. The State
issued does not result in a whole
Food, Drug, and Cosmetic Act and agency may establish different
number of containers, the State agency
regulations issued pursuant to the Act. minimums for different vendor peer
must round up to the next whole
(h) Rounding up. State agencies may groups.
container in order to issue whole
round up to the next whole container containers. * * * * *
for either infant formula or infant foods (2) Infant foods. (i) State agencies may Dated: July 20, 2006.
(infant cereal, fruits, vegetables and use the rounding up option to the next Eric M. Bost,
meat). State agencies that use the whole container of infant food (infant Under Secretary for Food, Nutrition and
rounding up option must calculate the cereal, fruits, vegetables and meats) Consumer Services.
amount of infant formula or infant foods when the maximum monthly allowance
provided according to the requirements cannot be issued due to varying Appendix
and methodology as described in this container sizes of authorized infant Note: This appendix will not be published
section. foods. in the Code of Federal Regulations.
(1) Infant Formula. State agencies (ii) State agencies that use the
must use the maximum monthly rounding up option for infant foods Regulatory Impact Analysis
allowance of reconstituted fluid ounces must: 7 CFR 246: Special Supplemental Nutrition
of liquid concentrate infant formula as (A) Use the methodology described in Program for Women, Infants, and Children
specified in Table 1 of paragraph (e)(9) paragraph (h)(2)(iii) of this section for (WIC): Revisions in the WIC Food Packages
of this section as the full nutritional calculating and dispersing the rounding Proposed Rule
benefit (FNB) provided by infant up option;
Executive Summary
formula for each food package category (B) Issue infant foods in whole
and infant feeding option (e.g., Food containers; and The WIC program addresses the
Package I A fully formula fed, IA–FF). (C) Disperse the number of whole supplemental nutritional needs of at-risk
groups through the distribution of
When using the rounding up option for containers as evenly as possible over the supplemental food packages, and a program
infant formula, State agencies must timeframe (the number of months the of nutrition education that includes
issue whole containers that provide at participant will receive the food counseling, health and social service
least the FNB but not more than the package). referrals, and breastfeeding promotion and
maximum monthly allowances as (iii) The methodology to round up support. WIC nutrition education provisions
specified in Table 1 of paragraph (e)(9) and disperse infant food is as follows: are governed by broad regulatory language
of this section. (A) Multiply the maximum monthly that allows nutrition education provided to
(i) State agencies that use rounding up allowance for the infant food by the participants to respond to the supplemental
of infant formula must: timeframe the participant will receive nutrition needs of participants in light of
changes in dietary and health research. In
jlentini on PROD1PC65 with PROPOSAL2
(A) Use the methodology described in the food package to determine the total
contrast, WIC supplemental food packages
paragraph (h)(1)(iii) of this section for amount of food to be provided. are defined very specifically in the regulatory
calculating and dispersing the rounding (B) Divide the total amount of food language. Consequently, as the population
up option; provided by the container size issued by served by WIC has grown and become more
(B) Issue infant formula in whole the State agency (e.g., ounces) to diverse over the last 20 years and as food
containers that are all the same size; and determine the total number of food consumption habits have changed, the
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44823
nutritional risks faced by participants have Summary of Rule and Benefits WIC supplemental food packages have
changed. Also, though nutrition science has Food Package I remained largely unchanged. This rule is
advanced, the WIC supplemental food Package II needed to implement recommended changes
packages have remained largely unchanged. Food Package III to the WIC food packages based on the
A rule is needed to implement recommended Food Package IV current supplemental nutritional needs of
changes to the WIC food packages based on Food Package V WIC participants and advances in nutrition
the current supplemental nutritional needs of Food Package VI science.
WIC participants and advances in nutrition Food Package VII
science. Other Provisions C. Affected Parties
The proposed rule would revise Summary of Key Provisions The program affected by this rule is the
regulations governing the WIC food packages Costs Special Supplemental Nutrition Program for
to revise the maximum monthly allowances Proposed Rule Women, Infants, and Children (WIC). The
and minimum requirements for certain Major Cost Drivers parties affected by this regulation are the
supplemental foods; revise the substitution Fruit and Vegetables Option USDA’s Food and Nutrition Service (FNS),
rates for certain supplemental foods and Cost Estimate Methodology State and local agencies that administer the
allow additional foods as alternatives; revise Food Costs WIC Program, retail vendors, and WIC
age specifications for assignment to infant Prescriptions participants.
food packages; add foods to children and Infant Formula and Rounding
Redemption Rates Effects
women food packages; and address general
provisions that apply to all food packages. Food Prices The following analysis describes the
The revisions reflect recommendations made Participant Projections potential economic impact of this proposed
by the Institute of Medicine of the National Phased Implementation rule. This rule is needed due to changes in
Academies in its Report ‘‘WIC Food State Cost Variation the population served by WIC, and advances
Packages: Time for a Change,’’ and certain Administrative Costs in nutrition and knowledge about the
administrative revisions found necessary by Uncertainties supplemental nutritional needs of those
the Department. Price Volatility in the Dairy Market served by WIC. The changes in this rule are
The revisions would also bring the WIC Reduce Assumed Preference for Soy significant to the costs or overall operations
food packages in line with the 2005 Dietary Beverage to the program. The potential effects of these
Guidelines for Americans and current infant Alternatives changes are highlighted below.
feeding practice guidelines of the American Include Yogurt as a Milk Substitute for
Food Packages IV–VII A. Background
Academy of Pediatrics: better promote and
support the establishment of successful long- More Restrictive Dark Green and Orange The WIC program was established in the
term breastfeeding; provide WIC participants Vegetable Rule 1970s to address the special supplemental
with a wider variety of food; provide WIC No Infant food Fruits, Vegetables or Meats nutritional needs of low-income pregnant
State agencies with greater flexibility in for Infants 6 Mos and Older and postpartum women, infants, and
prescribing food packages to accommodate Drop the Whole Grain Requirement for children up to age five who are determined
participants with cultural food preferences; Both Bread and Cereal to be at nutritional risk. Regulations
and, serve all participants with certain Market Share Analysis governing the WIC program recognize a broad
medical provisions under one food package Appendix: Additional Cost Estimate range of nutritionally related medical
to facilitate efficient management of Assumptions conditions for purposes of establishing
participants with special dietary needs. Date: July 17, 2006. program eligibility. These include anemia,
Significant changes in the food packages Agency: USDA, Food and Nutrition low birth weight, chronic infections,
include: the classification of infants in Food Service. overweight, underweight, and similar
Packages I and II and mothers in Food Contact: Cindy Long. manifestations of poor nutrition suitable for
Packages V, VI, and VII according to Phone: (703) 305–2340. direct measurement or diagnosis.1 WIC
breastfeeding practice; eliminating juice from Fax: (703) 305–2576. regulations also recognize that personal
Food Packages I and II; adding infant foods E-mail: cindy.long@fns.usda.gov. medical histories, dietary patterns, and
and meat for fully breastfed infants in Food Title: 7 CFR 246: Special Supplemental economic circumstances may put otherwise
Package II; adding whole grains, and fruits Nutrition Program for Women, Infants, and healthy women or children at nutritional
and vegetables to food packages for children Children (WIC): Revisions in the WIC Food risk. Certification may therefore be extended
(IV) and women (V and VII only); and, Packages. to women facing high-risk pregnancies,
revising the purpose, content and pregnant women or mothers who abuse
Action
requirements for Food Package III, currently alcohol or drugs, homeless women and
for children and women with special dietary A. Nature children, and infants and children with
needs. Proposed Rule. congenital malformations that may interfere
Under the proposed rule, revisions to the with adequate nutrient intake or absorption.2
WIC food packages are cost-neutral to the B. Need WIC addresses the supplemental nutritional
Federal Government. Specifically, FNS The WIC program addresses the needs of at-risk groups through the
estimates that the changes will result in a supplemental nutritional needs of at-risk distribution of age and condition-specific
cost savings of $34 million dollars over five groups through the distribution of age and food packages, and a program of nutrition
years, a negligible amount relative to the condition specific food packages, and a education that includes counseling, social
program’s annual cost of more than $5 program of nutrition education that includes service referrals, and breastfeeding
billion. counseling, health and social service promotion and support.
referrals, and breastfeeding promotion and WIC’s nutrition education provisions are
Table of Contents support. WIC nutrition education provisions governed by broad regulatory language that
Action are governed by broad regulatory language seeks to promote ‘‘proper nutrition,’’
Nature that allows nutrition education provided to ‘‘optimal use’’ of WIC’s supplemental foods,
Need participants to respond to changes in dietary and appropriate advice concerning non-WIC
Affected Parties and health research. In contrast, WIC foods.3 Compliance with this regulatory
Effects supplemental food packages are defined very mandate presumes that nutrition education
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Background specifically in the regulatory language. will respond to the supplemental nutrition
Current WIC Food Packages and Changing Consequently, as the population served by needs of participants based on advances in
Nutritional Priorities WIC has grown and become more diverse
Changing Demographics of the WIC over the last 20 years, the nutritional risks 17 CFR 246.7(e).
Population faced by participants have changed, and 2 Id.
Institute of Medicine’s Recommendations though nutrition science has advanced, the 37 CFR 246.11.
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44824 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
dietary and health research. The U.S. availability, and broad acceptance by the low calcium intake by pregnant and
Department of Agriculture’s (USDA) Food WIC-eligible population. breastfeeding women, birth defects caused by
and Nutrition Service (FNS) provides The nutritional risks faced by the low- inadequate folate consumption during
provision of nutrition education to WIC income population of the 1970s have pregnancy, iron-deficiency anemia, and heart
participants that is consistent with the 2005 changed. Although inadequate intake of some disease, diabetes, stroke, and cancer, all
Dietary Guidelines for Americans. nutrients remains a concern,5 improved diets linked to obesity and excessive intake of
WIC’s supplemental food packages, by have reduced the prevalence of once saturated fat.9 Adjustments to the WIC food
contrast, are defined by regulation with relatively common deficiency diseases and
specificity. The regulatory flexibility that packages that move the levels of these
underweight in at-risk groups. A WIC
characterizes WIC nutrition education does priority nutrients closer to Recommended
program that now assists nearly eight million
not extend to the prescription of individual individuals monthly, including about half of Dietary Allowances (RDAs) and Adequate
food packages. The list of WIC-approved the nation’s infants,6 supplements the diets Intake (AIs) levels of the Institute of
foods focused to provide select nutrient-rich of an at-risk population with the very types Medicine’s Dietary Reference Intakes may
foods; allowed substitutions provide only of iron-fortified, nutrient-dense foods reduce the nutrition-related medical health
limited room for participant-specific food associated with this changed health picture. risks of WIC participants.
package tailoring. WIC’s current food packages, little modified 2. Changing Demographics of the WIC
The population served by the WIC program since the 1970s, were appropriately designed Population
has grown in size and diversity over time and to address the recognized nutritional
the frequency of nutritional risks faced by priorities of that time. But today’s WIC The population served by WIC has grown
WIC participants have changed. Most population, like the U.S. population as a more diverse over time. (See Figure 1.) White
important, the content of existing WIC food whole, faces a reordered set of priorities. and Black participants represented 72% of
packages no longer reflects the leading views Excessive intakes of some nutrients, the WIC population in 1992; by 2004, just
of current nutrition science. including saturated fat, and of food energy 56% of WIC participants fell into one of
1. Current WIC Food Packages and Changing have taken a place among the nation’s top those two racial/ethnic groups.10 WIC’s
Nutritional Priorities public health concerns.7 Other nutrients, Hispanic population, itself a diverse group,
Supplemental foods are offered to WIC including folate, vitamin E, and fiber, have has grown from the third largest to the largest
participants in one of seven packages since been identified as lacking in the diets over the same period. Greater ethnic diversity
designed for the special supplemental of WIC-eligible sub-populations.8 While increases the demand for additional food
nutritional needs of the following sub- current WIC food packages continue to options consistent with cultural preferences.
populations: address important health risks of The introduction of new foods and
undernutrition, they do not target all
I. Infants under four months old substitution options should broaden the
identified inadequacies, and they may
II. Infants from four to twelve months old contribute to the risks associated with appeal of WIC food packages and increase the
III. Children and women with special dietary excessive intake of some nutrients. effectiveness of WIC’s educational message.
needs Medical consequences of improper diets Ultimately, wider acceptance of WIC-
IV. Children from one to five years old include fetal or infant lead toxicity tied to approved diets should improve the nutrition
V. Pregnant and breastfeeding women of underserved at-risk groups.
VI. Non-breastfeeding postpartum women 5 National Academies, Institute of Medicine
VII. Exclusively breastfeeding women (IOM). WIC Food Packages: Time for a Change,
9 See IOM, p. 63; see also ‘‘High Costs of Poor
Washington, D.C.: The National Academies Press, ˜
Eating Patterns in the States,’’ Elizabeth Frazao, in
Inadequate nutrition was the prime America’s Eating Habits: Changes and
motivating factor behind enactment of the 2005. pp. 31, 64.
6 U.S. department of Agriculture, Food and ˜
Consequences, Elizabeth Frazao, ed., Economic
WIC program.4 Nutrition research in the Research Service, U.S. Department of Agriculture,
Nutrition Web site, July 2005. www.fns.usda.gov/
1970’s pointed to calcium, iron, high quality Washington, D.C., 1999.
wic/FAQs/FAQ.HTM.
protein, and vitamins A and C as nutrients 7 See U.S. Department of Health and Human
10 U.S. Department of Agriculture, Food and
most likely to be lacking in the diets of low- Services and U.S. Department of Agriculture, Nutrition Service, Office of Analysis, Nutrition and
income women, infants, and children. Dietary Guidelines for Americans, 2005, 6th edition, Evaluation, WIC Participant and Program
Current WIC food packages reflect that early Washington D.C.: U.S. Government Printing Office, Characteristics 1992, Abt. Associates. Alexandria,
research. Today’s packages include some January 2005. (USDHHS/USDA, 2005). VA: 1994.
combination of: Iron-fortified infant 8 IOM, p.59. Note, however, that these U.S. Department of Agriculture, Food and
formulas, iron-fortified cereals, vitamin C conclusions are based on self-reported food Nutrition Service, Office of Analysis, Nutrition and
rich juice, vitamin A and D fortified milk, consumption data from the Continuing Survey of Evaluation, WIC Participant and Program
eggs, cheese, dried beans or peas, peanut Food Intakes by Individuals (1994–1996 and 1998.) Characteristics 2004, Abt. Associates. Alexandria,
Underreporting of food intakes is suspected by VA: 2005. The program characteristics studies
butter, tuna, and carrots. Other factors that
women involved in the survey. And, the data do not performed prior to 1992 did not include participant
contributed to the selection of these foods are data from Alaska, Hawaii, Puerto Rico, or U.S.
include nutrients consumed in the form of dietary
their nutrient density, modest cost, wide supplements. These factors may overstate the territories. The racial/ethnic breakdowns from those
problem of nutrient inadequacies, and may earlier reports should not be directly compared to
4 See 42 USC 1786(a). understate the problem of excessive intakes. the ones contained in reports from 1992 forward.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44825
3. Institute of Medicine’s Recommendations recommend changes in the content of the eligible and potentially WIC-eligible
FNS contracted with the National program’s food packages. IOM examined the populations.11 IOM identified and prioritized
Continuing Survey of Food Intakes of a list of micro- and macro-nutrients 12 whose
Academies’ Institute of Medicine (IOM) in
Individuals (CSFII) food consumption survey consumption by the targeted populations fell
2003 to assess the nutritional health profile data (see footnote 9) to evaluate the
of the current WIC population, and to outside of acceptable ranges.13 (See Table 1.)
nutritional content of the diets of WIC-
TABLE 1.—PRIORITY NUTRIENTS IDENTIFIED BY THE INSTITUTE OF MEDICINE (IOM) AS POSSIBLY INADEQUATE OR
EXCESSIVE IN THE DIETS OF WIC SUB-POPULATIONS
Inadequate (grouped by relative levels of inadequacy)
WIC subpopulation Excessive
Highest High Moderate
WIC infants:
Non-breastfed under age one ................. .................................... .................................... .................................... Zinc, preformed vita-
min A, food energy.
Breastfed, 6 to 11 months ...................... Iron, zinc.
WIC children:
Ages 1 to 4 ............................................. Vitamin E, fiber, po- .................................... .................................... Zinc, preformed vita-
tassium. min A, food energy,
saturated fat.
Women:
Pregnant, breastfeeding, non- Calcium, magnesium, Vitamins A, C, B6, and Iron, zinc, thiamin, Sodium and saturated
breastfeeding postpartum. vitamin E, potas- folate. niacin, protein. fat (as a percent of
sium, fiber. food energy).
IOM then recommended specific changes conformity with accepted recommendations; B. Summary of Rule and Benefits
to the current WIC food packages to improve encouraging and supporting breastfeeding, With few changes, the recommendations of
the nutritional balance of the diets of the WIC 4. Including foods in the WIC packages that the IOM have been adopted as this proposed
population. IOMs recommendations were are available in forms suitable for individuals rule. The provisions of the rule and the
guided by the following criteria: 14 with limited means of transportation, storage, potential benefits of these changes are
1. Reducing the prevalence of inadequate or cooking, summarized below.
or excessive nutrient intake by WIC 5. Including foods in the WIC packages that 1. Food Package I—Infants Under Six Months
participants, are commonly consumed and widely
Proposed rule: Tie maximum infant
2. Helping WIC participants achieve available, accommodate cultural preferences, formula prescriptions to breastfeeding
dietary patterns consistent with the 2005 and encourage WIC participation, and practice.
Dietary Guidelines for Americans for 6. Giving consideration to the impact that • Establish fully breastfed, partially
individuals two years of age and older,15 the proposed changes will have on vendors, breastfed, and fully formula-fed categories,
3. Bringing the diets of infants and and on state and local WIC agencies. and set maximum formula allowances for
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children under age two into closer each. Food Package I currently specifies a
11 See IOM, p. 46. IOM used CSFII data for infants 12 Micro-nutrients are nutrients the body requires 13 SeeIOM, pp. 46 through 60.
and children enrolled WIC. To maintain a sufficient in small amounts, e.g. vitamins and minerals. 14 IOM, p. 37.
sample size, IOM used CSFII results for all Macro-nutrients are nutrients that constitute the 15 IOM, p. 153–154, 156–157.
pregnant, breastfeeding, and non-breastfeeding majority of an individual’s diet, e.g. carbohydrates,
EP07AU06.000</GPH>
postpartum women. proteins, and fats.
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44826 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
single maximum formula amount for all be recognized as either fully breastfed or infants breastfeeding status on the mothers
Package I recipients; local WIC staff may fully formula-fed. No infant will be food package eligibility are greater. Mothers
tailor the amount of formula to reflect with prescribed formula in the amount specified whose infants are prescribed no more
individual participant needs, based on by Food Package I for partially breastfed formula than the maximum allowed for a
frequency of breastfeeding. The new rule sets infants until he or she reaches one month. partially breastfed infant will remain eligible
a maximum formula amount for partially Rationale and Benefits: By not offering a for Food Package V. Mothers who accept
breastfed infants that is roughly half the partially breastfed option for infants under more formula will be considered non-
maximum provided to fully formula fed one month old, the proposed rule intends to breastfeeding, and will be eligible for no food
infants. encourage mothers to continue a practice of package at all. The proposed rule encourages
• Powder formula alone is recommended breastfeeding that may have begun at the mothers to continue breastfeeding beyond six
for partially breastfed infants. Powder and hospital. Additionally, the amount of milk a months postpartum. Increasing the rate and
non-powder options remain available for breastfeeding woman produces depends duration of breastfeeding is a
fully formula fed infants. directly on how often and how long she recommendation of the AAP.17
Rationale and Benefits: nurses. Providing supplemental formula to a Proposed rule: Reduce maximum formula
• The infant breastfeeding categories are new mother may interfere with her milk prescription amounts. Reduce the amount of
intended to promote breastfeeding. production and success at continued formula, relative to current rules, for partially
Breastfeeding provides important nutritional breastfeeding. breastfed and fully formula-fed infants.
and health benefits beyond that provided by Proposed rule: No low iron formula. Rationale and Benefits: With the addition
formula feeding; it is the AAPs recommended Discontinue the prescription of low iron
of infant foods (see below), the revised
method of infant feeding.16 It is also infant formula for infants of all ages.
Package II provides close to the
proposed that the infants breastfeeding status Rationale and Benefits: Iron fortified
recommended levels of priority nutrients
be used to assign mothers to their own food formulas continue to play an important role
without excess food energy. Reducing
packages. Mothers of fully formula fed in preventing iron deficiency in infants. The
AAP recognizes no medical condition that formula prescriptions should encourage
infants under six months of age are assigned
would justify the feeding of low iron formula parents to introduce complementary foods to
to Food Package VI; partially breastfeeding
to infants. their infants beginning at six months of age.18
mothers of infants under six months are
assigned to Package V which is relatively Proposed rule: Reclassify prescriptions of Proposed rule: Replace juice with fruits
more attractive than Package VI for exempt infant formula under Package III. and vegetables.
postpartum women due to the inclusion of Administer exempt formulas, other than • Eliminate juice from Food Package II.
additional foods and higher maximum those prescribed for common food allergies, Add infant food fruits and vegetables to the
allowances for the same foods that are under Food Package III. Currently, all infants package. Allow fresh bananas as a substitute
provided in Package V. are classified as recipients of Food Packages for a portion of the infant food fruits and
• Classification of infants by breastfeeding I or II. This proposal would simply reclassify vegetables.
status makes it easier to ensure that partially certain Package I (and II) recipients as • Provide more infant food fruits and
breastfed infants are prescribed only powder Package III recipients; it is not intended to vegetables to fully breastfed infants than to
formula, the option recommended by IOM to alter the types of foods prescribed to infants partially breastfed or fully formula-fed
give parents greater control over the amount with qualifying conditions. infants.
of formula prepared. This should reduce Rationale and Benefits: Currently, only Rationale and Benefits:
waste and contribute to safer formula use. children and adults prescribed special • Increased fruit and vegetable
Proposed rule: Delay introduction of medical foods are classified as Package III consumption is among the major
complementary foods. Extend the age range recipients. Grouping together all recipients of recommendations of the 2005 Dietary
of infants covered by Food Package I by two medical foods and exempt formulas is meant Guidelines for Americans; commonly
months. Currently, Food Package I to increase management efficiency, and consumed fruits and vegetables provide
supplements the diets of infants from birth facilitate the tracking of the costs and several of the priority nutrients identified by
through three months. Under the proposed benefits of medical and exempt food the IOM.19 The introduction of fruits and
rule, Food Package I would be provided to prescriptions. vegetables at an early age may promote
infants through five months of age. Under 2. Food Package II—Infants 6 Through 11 acceptance and increased consumption.20
both the current and proposed rules, Food Months • Juice does not provide nutritional benefit
Package I contains no complementary foods. beyond that available from whole fruits and
Proposed rule: Delay introduction of vegetables.21
Extending the age range of infants served by
complementary foods. Delay the age at which • Eliminating juice offsets the cost of
Food Package I removes complementary
infants become eligible for Food Package II. providing infant food fruits and vegetables.
foods (juice and infant cereal) from the food Infants are currently made eligible for Food
packages for four and five month old infants. • Providing more infant food fruits and
Package II and its complementary foods at vegetables to fully breastfed infants
Rationale and Benefits: Delaying the four months of age. The proposed rule would
introduction of complementary foods until encourages the continuation of breastfeeding
make infants eligible for Package II foods at by increasing the value of the fully breastfed
the infant reaches six months is consistent six months of age.
with the current recommendations of the package.22 It also seeks to provide an amount
Rationale and Benefits: Delaying the
American Academy of Pediatrics (AAP). sufficient to mix with infant food meat to
introduction of complementary foods until
Proposed rule: Increase maximum formula improve palatability and acceptance of that
the infant reaches six months is consistent
prescription at four months. Increase the food. (See below.)
with the current recommendations of the
maximum amount of formula allowed for Proposed rule: Provide infant food meat to
AAP.
four and five-month-old infants (relative to fully breastfed infants. Add infant food meat
Proposed rule: Tie maximum formula
the amount allowed under current rules.) to Package II for fully breastfed infants.
prescription to breastfeeding practice.
Rationale and Benefits: Calories lost Rationale and Benefits: Infant food meat
Establish fully breastfed, partially breastfed,
through elimination of juice and infant cereal supplies iron and zinc for infants age six
and fully formula-fed categories, and set
from Food Package I are replaced, in part, months and older, that breast milk alone does
maximum formula allowances for each. The
with increased formula prescription new rule sets a maximum formula amount for not supply. Increasing the value of the fully
amounts. The package better meets the partially breastfed infants that is roughly half breastfed package is also intended to
nutritional needs of the infant through to the maximum provided to fully formula-fed encourage continued breastfeeding.
month 6. infants.
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Proposed rule: No partially breastfed Rationale and Benefits: Like the 17 IOM, p. 69.
category for infants under one month. Do not corresponding proposal under Food Package 18 IOM, pp. 94, 113.
provide formula to breastfed infants under I, Package II breastfeeding categories will be 19 IOM, p. 100.
one month old. Infants under one month will used to assign mothers to their own food 20 Id.
packages. However, once an infant reaches 21 IOM, p. 103.
16 IOM, pp. 5, 6, 69. six months of age, the consequences of the 22 IOM, p. 94.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44827
Proposed rule: No low iron formula. medical conditions that qualify a WIC the 2005 Dietary Guidelines for Americans or
Discontinue the prescription of low iron participant for Package III medical foods. other dietary guidance.25
infant formula. • Prescription of a medical food would • Reducing the amount of cheese that may
Rationale and Benefits: Iron fortified also require additional justification and be substituted for milk will reduce saturated
formulas continue to play an important role instructions by a licensed health care fat and total fat intake by children age two
in preventing iron deficiency in infants. The professional. and older. (See next proposal on fat reduced
AAP recognizes no medical condition that • The proposal would also clarify the milk.) This proposal will also offset costs,
would justify the feeding of low iron formula definition of WIC-eligible medical foods. allowing for the addition of other foods.
to infants. Rationale and Benefits: The threshold of • The 2005 Dietary Guidelines for
Proposed rule: Reclassify prescriptions of eligibility for Package III medical foods is Americans stresses the importance of milk
exempt infant formula under Package III. currently unclear. The distinction between consumption in the development of bone
Administer exempt formulas to infants under conventional foods marketed to the mass in children.26 While soy products may
Food Package III. medically needy and WIC authorized be an appropriate choice for children who
Rationale and Benefits: Grouping together medical foods can also be difficult to make. cannot consume milk, the IOM does not
all recipients of medical foods and exempt
The proposed rule will provide guidance to believe that soy should be made available to
formulas is meant to increase management
state agencies that should promote efficiency satisfy participant preference in the absence
efficiency, and facilitate the tracking of the
and reduce the costs of restricting Package III of medical need.
costs and benefits of medical and exempt
food prescriptions. to participants with qualifying medical • IOM recommended yogurt as an
Proposed rule: Disallow prescription of conditions. alternative to fluid milk. To ensure cost
infant cereal with added ingredients. Infant Proposed rule: Make non-Package III foods neutrality yogurt was omitted as a fluid milk
cereal with added fruit, milk, formula, or available to Package III recipients. In substitution. (See discussion of yogurt as a
other non-grain foods may not be prescribed addition to the medical foods and exempt milk substitute on page 51.)
under Food Package II. formulas currently prescribed to Package III Proposed rule: Provide only fat-reduced
Rationale and Benefits: As recommended recipients, the proposed rule would offer milk to older children. Prescribe only fat-
by IOM, the proposed rule formalizes federal these individuals all of the foods in the reduced milk to children age two and above.
policy 23 which states that cereal packages to which they would have been Prescribe only whole milk to children under
combinations are not allowed. The eligible in the absence of their special age two.
Department’s policy is based on medical needs. Rationale and Benefits: Increases the
recommendations of the American Academy Rationale and Benefits: Provides Package likelihood that the amount of total fat and
of Pediatrics and costs concerns. The III recipients access to the same set of saturated fat in the diets of children age two
American Academy of Pediatrics nutrients as other WIC recipients at the same and over will be consistent with the 2005
recommends that single ingredient foods be life stage. An individual’s health constraints, Dietary Guidelines for Americans. This is
introduced one at a time in an effort to isolate not his or her administrative status as a also consistent with the recommendations of
food sensitivities and possibly avert the Package III recipient, are all that should limit the American Academy of Pediatrics.
development of food intolerances. Although the prescription of foods from a standard Proposed rule: Modify/clarify
cereal/fruit combinations may be appropriate WIC package. reconstitution rates for dry and evaporated
once the risk of sensitivity has diminished, 4. Food Package IV—Children From Age One milk. The reconstitution rate for evaporated
these combination foods are more expensive Up to Age Five milk is changed from 13 to 16 ounces of
than regular infant cereal. Therefore, in an evaporated milk per reconstituted quart. The
effort to contain the cost of the food Proposed rule: Reduce the prescribed reconstitution rate for powdered milk is
packages, the Department has not authorized amount of milk; modify substitution options. restated in terms of fluid ounces rather than
them. In reference to cereal/formula quarts; this change does not alter the
combinations, since infant formula is already • The amount of milk that may be reconstitution rate itself.
provided in the food packages, the prescribed to children would be reduced Rationale and Benefits: The proposed
Department does not believe it is necessary from 24 quarts to 16 quarts per month. reconstitution rate for evaporated milk
to provide additional infant formula in • Under current rules, cheese may be reflects its degree of concentration.
combination with infant cereal. prescribed as a substitute for up to 12 quarts Restatement of the reconstitution rate of
3. Food Package III—Medically Fragile of milk. The proposed rule would allow powdered milk is intended to assist state
Participants cheese to replace up to three quarts of milk. agencies in making reconstitution
The substitution rate of one pound of cheese calculations for a growing range of powdered
Proposed rule: Administer exempt for three quarts of milk would remain
formulas to infants with qualifying milk container sizes.
unchanged. Proposed rule: Reduce juice prescriptions;
conditions under Package III. • Soy products will be allowed as a milk
Infants with a qualifying condition (see add fruits and vegetables.
substitute on a restricted basis; soy may only • Reduce monthly maximum juice
below) who currently receive exempt infant be prescribed to children with a documented
formulas would be moved from Package I or prescription from 288 fluid ounces to 128.
medical need. Clarify that juice must be 100% unsweetened
Package II to Package III.
Rationale and Benefits: fruit or vegetable juice, that it contain a
Rationale and Benefits: The current
• Reducing the amount of milk provided to minimum of 30 milligrams of vitamin C per
system, which assigns infants with special
children brings the prescribed amounts into 100 milliliters, and that it be pasteurized.
dietary needs to either Packages I or II, while
women and children with special dietary
conformance with recommended limits on • Add a $6 monthly voucher to the
needs are placed in Package III, makes it saturated fat and total fat consumption by package for the purchase of any combination
difficult to track participation and costs children as a percent of food energy and with of fresh or processed fruits and vegetables.
associated with providing medical foods. the 2005 Dietary Guidelines for Americans, Rationale and Benefits:
Grouping infants with qualifying conditions and reduces the prevalence of inadequate • Increased fruit and vegetable
with the category of women and children and excessive nutrient intakes. Reduced consumption is among the major
receiving medical foods is expected to intake of saturated fat is associated with recommendations of the 2005 Dietary
increase management efficiency and facilitate decreased risk of coronary heart disease; total Guidelines for Americans; commonly
the tracking of the costs and benefits of fat intake in excess of 35% of food energy consumed fruits and vegetables provide
serving this segment of the WIC population. makes it difficult to limit total calories to several of the priority nutrients identified by
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Proposal: Clarify language governing recommended levels.24 As noted by IOM, the the IOM. Evidence also suggests that fruit
Package III’s purpose and scope. revised amount of fat-reduced milk and milk and vegetable consumption is associated
• The proposed rule would provide products in Food Package IV are with reduced incidence of some chronic
additional guidance to states on the nature of approximately the amount recommended in
25 IOM, p. 153.
23 November 12, 1980 final rule. 24 USDHHS/USDA, 2005, p. 29. 26 USDHHS/USDA, 2005, p. 24.
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44828 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
diseases.27 And the introduction of fruits and can reduce the risk of chronic disease, and pound of tofu would replace one quart of
vegetables at an early age may promote may help individuals control their weight.32 milk. For most women, cheese and tofu,
acceptance and increased consumption. • Allowing a variety of substitutes for combined, could replace no more than four
• Juice does not provide nutritional benefit whole grain bread increases the likelihood of quarts of milk; women with documented
beyond that available from whole fruits and participant acceptance by accommodating medical needs may be prescribed these
vegetables. individual taste and cultural preference. substitutes in amounts that exceed the four
• A voucher, rather than a more narrowly Proposed rule: Reduce maximum egg quart maximum. No more than one pound of
defined fruit and vegetable option, offers prescription. Reduce the maximum egg cheese may be substituted for milk.
flexibility, ensures participant access, and prescription from two and one-half dozen per • Soy beverage would be allowed as a
minimizes costs of compliance by month 33 to one dozen. substitute for Package V’s entire milk
administrative agencies and WIC-approved Rationale and Benefits: This reduction is allowance.
vendors. Allowing participants to choose any consistent with the 2005 Dietary Guidelines • IOM recommended yogurt as an
variety of fruits or vegetables 28 is intended for Americans and with IOM’s alternative to fluid milk. To ensure cost
to increase consumption by accommodating recommendation that dietary levels of neutrality yogurt was omitted as a fluid milk
cholesterol be reduced, where possible, substitution. (See discussion of yogurt as a
individual and culturally based preferences.
consistent with an adequate diet. Protein is milk substitute on page 51.)
The voucher form also ensures that some
variety of fresh or processed fruits and
no longer a priority nutrient for • States may limit allowable milk
supplementation.34 substitutes to soy beverage if needed to
vegetables will be available, year-round, at Proposed rule: Allow canned beans as a
most food stores. And state and local WIC control food costs.
substitute for dry beans. Allow canned beans Rationale and Benefits:
agencies need not tailor specific fruit and as a substitute for dry at the rate of sixty-four
vegetable prescriptions to participants, nor • Reducing the amount of milk provided
ounces per pound. through WIC is consistent with
will they be burdened with additional rules Rationale and Benefits: Accommodates recommended limits on saturated fat, total
governing substitution between fresh and participant preference and may encourage fat, and cholesterol consumption by
processed forms. consumption because canned beans can be American adults put forth in the 2005 Dietary
• Reducing juice partially offsets the cost prepared more quickly than dried beans. Guidelines for Americans. Reduced intake of
of providing fruit and vegetable vouchers. saturated fat is associated with decreased risk
5. Food Package V—Pregnant and Partially
• IOM recommended cash-value food of coronary heart disease; and total fat intake
Breastfeeding Women Up to One Year
instruments for fruits and vegetables at the in excess of 35% of food energy makes it
Postpartum
level of $8 per month for children. To ensure difficult to limit total calories to
cost neutrality, cash-value food instruments Proposed rule: Condition eligibility for
recommended levels.36 As noted by IOM, the
for fruits and vegetables was decreased to $6 Package V on breastfeeding practice. Mothers
revised amount of fat-reduced milk and milk
per month. (See discussion of fruit and who request, and are prescribed, more than
products in Food Package V are
vegetable option on page 36.) the maximum amount of formula allowed for
approximately the amount recommended in
Proposed rule: Add whole grain breads; partially breastfed infants will no longer be
the 2005 Dietary Guidelines for Americans.37
add whole grain requirement to cereal. eligible for Food Package V. Currently,
• Reducing the amount of cheese that may
• Add two pounds of whole grain bread to women who breastfeed at least once per day
be substituted for milk may reduce saturated
the food package. Only bread meeting U.S. are eligible for this package. Reclassified as
fat and total fat intake by participants.
Food and Drug Administration (FDA) non-breastfeeding for purposes of WIC
Limiting substitutions of cheese and tofu to
standards for whole grain labeling would be eligibility, these women will be assigned
four quarts of milk will reduce costs. This
allowed.29 Food Package VI up to six months
postpartum; they will receive no food permits the addition of other food and
• Several whole grain products would be substitution options to the package.
package after six months.
allowed as substitutions for bread. These
Rationale and Benefits: This is consistent • Allowing tofu and soy beverage as
include brown rice, bulgur, and whole grain substitutes for milk may help ensure
barley without added sugar, fat, oil, or with the proposed rule governing the
breastfeeding status of infants (see adequate calcium intake by individuals who
sodium. Soft corn or whole wheat tortillas do not or cannot consume milk. These
explanation under sections 1 and 2). The rule
would be allowed as an additional substitute products are culturally preferable to milk
provides an incentive for mothers to
at the option of state agencies. States may within some groups, and may be consumed
breastfeed their infants. This provision is
limit or completely eliminate substitutes if by individuals with lactose maldigestion.
designed to better promote and support the
needed to control food costs. Proposed rule: Reduce maximum juice
establishment of successful long-term
• Require that WIC authorized breakfast prescription; add fruits and vegetables.
breastfeeding among women and encourages
cereals 30 meet the same whole grain
a greater contribution of breast milk to the • Reduce monthly maximum juice
requirements as bread. prescription from 288 fluid ounces to 144.
infant’s diet.
Rationale and Benefits: Clarify that juice must be 100% unsweetened
Proposed rule: Reduce the prescribed
• This proposal is consistent with current fruit or vegetable juice, that it contain a
amount of milk; introduce new substitution
recommendations that Americans consume at options. minimum of 30 milligrams of vitamin C per
least three ounce equivalents of whole grain • The maximum amount of milk that may 100 milliliters, and that it be pasteurized.
foods daily as stated in the 2005 Dietary be prescribed to Package V recipients would • Add an $8 monthly voucher to the
Guidelines for Americans.31 Whole grains be reduced from 28 quarts to 22 quarts per package for the purchase of any combination
provide dietary fiber, a priority nutrient month. of fresh or processed fruits and vegetables.
identified by the IOM. Consumption of • Under current rules, cheese may be Rationale and Benefits:
recommended amounts of whole grain foods prescribed as a substitute for up to 12 quarts • (The rationales and benefits for this
of milk. The proposed rule would allow proposal are the same as those for the
27 IOM, p. 100. cheese to replace just three quarts of milk. introduction of fruits and vegetables to Food
28 Limited exceptions to individual choice The substitution rate of one pound of cheese Package IV. See explanation under section 4.)
include white potatoes, herbs, breaded vegetables, for three quarts of milk would remain • IOM recommended cash-value food
soups, salad bar items, pickles, juice, edible unchanged. instruments for fruits and vegetables at the
blossoms, decorative gourds and painted pumpkins. • Calcium-set tofu 35, and calcium and level of $10 per month for women. To ensure
29 See 21 CFR Part 136, Section 136.180, and
vitamin D fortified soy beverage would be cost neutrality, cash-value food instruments
FDA’s Health Claim Notification for Whole Grain for fruits and vegetable was decreased to $8
introduced as new milk substitutes. Each
jlentini on PROD1PC65 with PROPOSAL2
Foods with Moderate Fat Content at
per month. (See discussion of fruit and
www.cfsan.fda.gov/∼dms/flgrain2.html.
30 The proposed rule would also replace the 32 Id. vegetable option on page 36.)
existing terms ‘‘cereal (hot or cold)’’ and ‘‘adult 33 Some states currently allow just two dozen as Proposed rule: Add whole grain breads.
cereal (hot or cold)’’ with ‘‘breakfast cereal’’ in 7 the monthly maximum.
CFR 246.10(c). 34 IOM, pp. 82, 108. 36 USDHHS/USDA, 2005, p. 29.
31 USDHHS/USDA, 2005, p. 25. 35 Tofu prepared with only calcium salts. 37 IOM, p. 153.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44829
• Add one pound of whole grain bread to • Soy beverage would be allowed as a cheese to replace just six quarts of milk. The
the food package. Only bread meeting FDA substitute for Package VI’s entire milk substitution rate of one pound of cheese for
standards for whole grain labeling would be allowance. three quarts of milk would remain
allowed. • IOM recommended yogurt as an unchanged.
• Several whole grain products would be alternative to fluid milk. To ensure cost • Calcium-set tofu, and calcium and
allowed as substitutions for bread. These neutrality yogurt was omitted as a fluid milk vitamin D fortified soy beverage would be
include brown rice, bulgur, and whole grain substitution. (See discussion of yogurt as a introduced as new milk substitutes. Each
barley without added sugar, fat, oil, or milk substitute on page 51.) pound of tofu would replace one quart of
sodium. Soft corn or whole wheat tortillas • States may limit allowable milk milk. For most women, cheese and tofu,
would be allowed as an additional substitute substitutes to soy beverage if needed to combined, could replace no more than six
at the option of state agencies. States may control food costs. quarts of milk; women with documented
limit or completely eliminate substitutes if Rationale and Benefits: medical needs may be prescribed these
needed to control food costs. • As noted by IOM, the revised amount of substitutes in amounts that exceed the six
Rationale and Benefits: (See discussion for fat-reduced milk and milk products in Food quart maximum. No more than two pounds
Package VI includes more than two thirds of of cheese may be substituted for milk.
comparable proposal under section 4.)
the 2005 Dietary Guidelines for Americans • Soy beverage would be allowed as a
Proposed rule: Reduce maximum egg
recommended amounts.38 substitute for Package VII’s entire milk
prescription. Reduce the maximum egg
• (See the discussion for the comparable allowance.
prescription from two and one-half dozen per • IOM recommended yogurt as an
month to one dozen. proposal under section 5.)
Proposed rule: Reduce maximum juice alternative to fluid milk. To ensure cost
Rationale and Benefits: This reduction is neutrality yogurt was omitted as a fluid milk
prescription; add fruits and vegetables.
consistent with the 2005 Dietary Guidelines substitution. (See discussion of yogurt as a
• Reduce monthly maximum juice
for Americans and with IOM’s milk substitute on page 51.)
prescription from 192 fluid ounces to 96.
recommendation that dietary levels of • States may limit allowable milk
Clarify that juice must be 100% unsweetened
cholesterol be reduced, where possible, substitutes to soy beverage if needed to
fruit or vegetable juice, that it contain a
consistent with an adequate diet. In addition, control food costs.
minimum of 30 milligrams of vitamin C per
the IOM determined that protein is no longer 100 milliliters, and that it be pasteurized. Rationale and Benefits:
a priority nutrient for the WIC population. • Add an $8 monthly voucher to the • As noted by IOM, the revised amount of
Proposed rule: Allow canned beans as a package for the purchase of any combination fat-reduced milk and milk products in Food
substitute for dry beans. Allow canned beans of fresh or processed fruits and vegetables. Package VII approximately meets the 2005
as a substitute for dry at the rate of sixty-four Rationale and Benefits: Dietary Guidelines for Americans
ounces per pound. • (See the discussion for the comparable recommended amount.39 The maximum milk
Rationale and Benefits: Accommodates proposal under section 4.) prescription under Package VII is reduced by
participant preference and may encourage • IOM recommended cash-value food just 14%; the comparable reductions under
consumption because canned beans can be instruments for fruits and vegetables at the Packages V and VI are 21% and 33%,
prepared more quickly than dried beans. level of $10 per month for women. To ensure respectively. In addition, Package VII
Proposed rule: Increase total amount of cost neutrality, cash-value food instruments recipients are permitted to substitute up to
peanut butter and beans Peanut butter is for fruits and vegetable was decreased to $8 six quarts of milk with tofu and cheese; the
currently offered as a substitute for dry per month. (See discussion of fruit and other women’s packages limit milk
beans. The proposal would provide both one vegetable option on page 36.) substitutes to four quarts. Package VII, which
pound of dry beans and 18 ounces of peanut Proposed rule: Reduce maximum egg currently provides more food energy and
butter to Package V recipients. The rule also prescription. Reduce the maximum egg nutrients than do Packages V and VI, is made
clarifies that Package V recipients may prescription from two and one-half dozen per more attractive relative to these other
replace both dry beans and peanut butter month to one dozen. packages as a result of this proposal. This is
with canned beans. Rationale and Benefits: This reduction is consistent with the general aim of the rule to
Rationale and Benefits: This adds food consistent with the 2005 Dietary Guidelines encourage the incidence and duration of
energy and priority nutrients to the diets of for Americans and with IOM’s breastfeeding in the WIC population and to
breastfeeding women, including iron, folate, recommendation that dietary levels of meet the supplemental nutritional needs of
Vitamin E, and fiber. cholesterol be reduced, where possible, breastfeeding women.
consistent with an adequate diet. • (See the discussion for the comparable
6. Food Package VI—Postpartum Women (Up proposal under section 5.)
to Six Months Postpartum) Proposed rule: Add beans and peanut
butter to the food package. One pound of dry Proposed rule: Reduce maximum juice
Proposed rule: Reduce the prescribed prescription; add fruits and vegetables.
beans or 18 ounces of peanut butter would
amount of milk; introduce new substitution
be added to Package VI. The same canned • Reduce monthly maximum juice
options. prescription from 336 fluid ounces to 144.
bean substitution option added to Packages
• The maximum amount of milk that may IV, V, and VII would be extended to Package Clarify that juice must be 100% unsweetened
be prescribed to Package VI recipients would VI recipients as well. fruit or vegetable juice, that it contain a
be reduced from 24 quarts to 16 quarts per Rationale and Benefits: The proposal minimum of 30 milligrams of vitamin C per
month. would supplement the diets of postpartum 100 milliliters, and that it be pasteurized.
• Under current rules, cheese may be women with several priority nutrients, • Add an $8 monthly voucher to the
prescribed as a substitute for up to 12 quarts including iron, folate, Vitamin E, and fiber. package for the purchase of any combination
of milk. The proposed rule would allow of fresh or processed fruits and vegetables.
cheese to replace just three quarts of milk. 7. Food Package VII—Exclusively • Eliminate the separate prescription of
The substitution rate of one pound of cheese Breastfeeding Women carrots.
for three quarts of milk would remain Proposed rule: Reduce the prescribed Rationale and Benefits:
unchanged. Calcium-set tofu, and calcium amount of milk; introduce new substitution • (See the discussion for the comparable
and vitamin D fortified soy beverage would options. proposal under section 4.)
be introduced as new milk substitutes. Each • The maximum amount of milk that may • IOM recommended cash-value food
pound of tofu would replace one quart of be prescribed to Package VII recipients would instruments for fruits and vegetables at the
milk. For most women, cheese and tofu, be reduced from 28 quarts to 24 quarts per level of $10 per month for women. To ensure
jlentini on PROD1PC65 with PROPOSAL2
combined, could replace no more than four month. cost neutrality, cash-value food instruments
quarts of milk; women with documented • Under current rules, cheese may be for fruits and vegetable was decreased to $8
medical needs may be prescribed these prescribed as a substitute for up to 12 quarts per month. (See discussion of fruit and
substitutes in amounts that exceed the four of milk. The proposed rule would allow vegetable option on page 36.)
quart maximum. No more than one pound of
cheese may be substituted for milk. 38 IOM, p. 153. 39 IOM, p. 153.
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44830 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
Proposed rule: Add whole grain breads. products, by brand or variety, from the food adjustments for economic and administrative
• Add one pound of whole grain bread to packages distributed to their residents. States convenience, i.e., requiring least expensive
the food package. Only bread meeting FDA are authorized to set standards for WIC brands, packaging or physical forms of WIC
standards for whole grain labeling would be approval that are more restrictive than those supplemental foods.
allowed. set by the federal government; they may not Proposed rule: Prohibit states from
• Several whole grain products would be authorize the prescription of foods that do petitioning the USDA for new food package
allowed as substitutions for bread. These not meet minimum WIC-eligibility substitutions. A process is currently in place
include brown rice, bulgur, and whole grain requirements set forth in regulations. The to accept and evaluate requests by state WIC
barley without added sugar, fat, oil, or states may take into account issues of cost, agencies to add new foods to the program’s
sodium. Soft corn or whole wheat tortillas nutrition, statewide availability, and list of allowed substitutes. This process is
would be allowed as an additional substitute participant appeal in setting these designed to permit appropriate consideration
at the option of state agencies. States may restrictions. of the cultural norms and preferences of the
limit substitutes if needed to control food Rationale and Benefits: Federal diverse client populations of the different
costs. specifications for WIC-approved foods are state WIC agencies.
Rationale and Benefits: (See discussion for designed to ensure minimum standards of Rationale and Benefits: Since 1980, the
comparable proposal under section 4.) nutrition in food packages that appeal Department has only received 10 food
Proposed rule: Reduce maximum egg broadly to American consumers and can be package petitions. Developing, reviewing,
prescription. Reduce the maximum egg provided at a reasonable cost. Permitting the and analyzing cultural food package
prescription from two and one-half dozen per states to set additional criteria consistent proposals is a time consuming process for
month to one dozen. with their own market and population WIC State agencies and the Department. The
Rationale and Benefits: This reduction is profiles encourages the development of state-
increased variety and choice in the
consistent with the 2005 Dietary Guidelines approved food lists that meet or exceed
supplemental foods proposed in the rule will
for Americans and with IOM’s nutritional standards, maintain participant
provide state agencies increased flexibility in
recommendation that dietary levels of acceptance, and control costs.
prescribing culturally appropriate packages
cholesterol be reduced, where possible, Proposed rule: Ends the state practice of
for diverse groups without the need to
consistent with an adequate diet. categorical nutritional tailoring. States will
no longer be permitted to construct their own petition the Department for such changes.
Proposed rule: Allow canned beans as a
standardized set of food packages for WIC The IOM was charged with considering the
substitute for dry. Allow canned beans as a
subpopulations with common supplemental cultural needs of WIC participants and its
substitute for dry at the rate of sixty-four
nutritional needs. The full maximum recommendations for revisions to the WIC
ounces per pound. Also clarifies that Package
monthly allowances of all foods in all food packages reflect those considerations.
VII recipients may replace both dry beans
packages must be made available to Proposed rule: Rounding up for infant food
and peanut butter with canned beans.
participants if medically or nutritionally and infant cereal. A state agency would be
Rationale and Benefits: Accommodates
warranted. allowed to round up to the next whole
participant preference and may encourage
Rationale and Benefits: The IOM identified container of infant foods (i.e., infant cereal,
consumption.
several nutrients, including saturated fat, and fruits, vegetables and meats) if needed to
Proposed rule: Modify Package VII’s
identified food energy, that are provide at least the maximum authorized
canned fish provision.
• Increase the maximum canned fish overconsumed by some WIC-eligible amount of these foods. The proposal requires
prescription to 30 ounces. Clarify that fish subpopulations. Long before the IOM report, calculating and dispersing the infant formula
packaged in foil pouches meets WIC however, overweight and obesity in the U.S. over the timeframe of the food package
requirements. were recognized as public health issues. category and infant feeding option.
• Allow three varieties of canned fish that Categorical nutritional tailoring is the state Rationale and Benefits: This is consistent
do not pose a mercury hazard as identified practice of formalizing these modifications with the provision in Pub. L. 108–265 that
by federal advisories of the Food and Drug into a standard set of food packages that are allows states to round up to the next whole
Administration and the U.S. Environmental prescribed in place of the USDA-designed can of infant formula so that participants may
Protection Agency for breastfeeding women. packages. The revisions to the WIC packages receive the full authorized nutritional
Rationale and Benefits: proposed by this rule make categorical benefit. This proposal would require state
• For ease of administration by State tailoring unnecessary and inappropriate. The agencies to issue at least the full nutritional
agencies, to accommodate participant revised packages are designed to deliver an benefit but not more than the maximum
preferences, and to minimize intake of appropriate set of nutrients when foods are monthly allowance for the food package
mercury, the proposed rule would allow only prescribed at the specified maximums. category and infant feeding option.
canned light tuna, salmon and sardines. Participants may still refuse amounts of or
entire foods, and foods that pose a risk to the C. Summary of Key Provisions
• Increasing quantity provides
breastfeeding women with more protein and participant’s health (e.g., a food that causes The expected impact of the proposed rules
omega-3 fatty acids. an allergic reaction) should not be on the Federal Government, state and local
prescribed. Additionally, individual WIC agencies, vendors, manufacturers, and
8. Other Provisions (Non Food-Package nutritional tailoring, based on the Competent program participants is summarized in Table
Specific) Professional Authority’s assessment of a 2. Overall economic effects are noted with a
Proposed rule: Clarifies the right of states participant’s nutrition needs, is still allowed. ‘‘+$’’ for cost increases, and a ‘‘¥$’’ for cost
to impose restrictions on WIC foods. States This provision would not preclude state savings. A more detailed examination of
retain the right to exclude particular agencies from making administrative strictly economic effects follows Table 2.
TABLE 2.—SUMMARY OF KEY PROVISIONS
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
Current rule:
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44831
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
1. Food Package I serves infants from Reduces cost of infant Changes to current May increase the sale Provides a food pack-
birth through three months. Formula is food packages. Pro- rules will require the of infant formula at age that conforms
the only food prescribed under Pack- posed packages for implementation of the expense of juice more closely to the
age I. four and five month new state and local and infant cereal. diet recommended
old infants (which administrative pro- by health profes-
reduce calories cedures. sionals for four and
slightly) are less ex- five month old in-
pensive than current fants.
Food Package II.
2. Infants from four through eleven
months are eligible for juice and infant
cereal, in addition to formula, under
Package II. The maximum formula
prescription in packages I and II are
the same.
Proposed rule:
1. Expand Food Package I to serve in-
fants up to six months. Delay the in-
troduction of complementary foods by
two months.
2. Increase formula prescriptions at four
months to offset lost food energy.
¥$
Current rule:
Under Food Package I, an infant can re- May slightly reduce State and local agen- Negligible effect on Encourages
ceive up to the maximum for the the costs of pro- cies must develop the sale of infant breastfeeding. Addi-
package. Since the rule does not sep- viding infant formula new guidelines to formula for newborn tional support pro-
arate partially and fully formula fed in- to mothers during implement and com- infants. But, the rule vided to new moth-
fants, a single package maximum ap- their infants’ first municate this policy. provides an incen- ers by WIC staff
plies to all partially and fully formula- month. However, a tive to breastfeed, may successfully in-
fed infants from birth through three sustained increase which may ulti- crease
months. in breastfeeding mately reduce for- breastfeeding rates.
during an infant’s mula sales beyond This is consistent
first year will affect the infants’ first with the rec-
the food package month. But, the rule ommendations of
eligibility of both the may slightly in- nutrition experts.
mother and the in- crease infant food However, it is un-
fant. Although the sales to fully certain whether this
economic effect of breastfed WIC in- will have a signifi-
such a sustained in- fants 6 months of cant impact on the
crease is dependent age and older, and number of WIC
on both may increase the women who
breastfeeding dura- sale of other WIC breastfeed.
tion and on the rel- foods to
ative rates of partial breastfeeding moth-
and exclusive ers.
breastfeeding, the
net economic effect
is likely to be a re-
duction in cost.
Proposed rule:
Provide no infant formula to mothers
who breastfeed during the infant’s first
month.
¥$
Current rule:
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44832 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
The current infant food packages do not If the proposed rule State and local agen- Negligible effect in the Encourages
distinguish between fully and partially has no effect on the cies must conform absence of changes breastfeeding con-
formula-fed infants. Infants receive in- initiation and dura- to a new definition in breastfeeding be- sistent with the best
fant formula based on an assessment tion of of breastfeeding for havior. Increased advice of nutrition
of their supplemental nutritional breastfeeding, the WIC food package breastfeeding would science. Will reduce
needs, subject to a single package cost of providing purposes. Will also reduce formula the WIC benefit re-
maximum.Food Package V is pro- food packages to encourage changes sales but might ceived by women
vided to pregnant women and to all women will drop; in the approach to modestly increase who do not fully
new mothers, up to one year the cost of providing nutrition education; the sale of infant breastfeed.
postpartum, if they breastfeed at least infant formula will places greater em- food fruits, vegeta-
once per day. remain unchanged. phasis on bles and meat to
If breastfeeding in- breastfeeding pro- WIC’s fully
creases enough to motion. Imple- breastfed popu-
keep an infant clas- menting new proce- lation.
sified as partially dures will initially in-
breastfed who crease administra-
would have been tive burden.
classified as fully
formula fed other-
wise, then formula
costs are reduced
and there is no
change in the moth-
er’s status. Both re-
sult in cost reduc-
tions.
Proposed rule:
Infants and mothers will be assigned
food packages based on the mother’s
reported breastfeeding practice. The
corresponding amount of formula pre-
scribed will distinguish infants be-
tween partially breastfed and fully for-
mula-fed. The rule would provide a full
formula-feeding package to some in-
fants currently considered partially
breastfed; it would move some moth-
ers 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 The net effect of this State agencies will be Negligible effect be- Encourages more in-
in WIC regulations allows women who change is minimal. provided NSA funds cause the few tensive
breastfeed once a day to be eligible These women will for a very small women who once breastfeeding for
for the WIC program and receive sup- be included in par- number of women received supple- WIC women.
plemental foods. ticipation numbers who are receiving mental foods will no
and State agencies WIC benefits (nutri- longer be eligible for
will be provided tion education/ these foods.
NSA funds, but breastfeeding sup-
there are very few port and referrals to
of them and they health and social
will not be receiving services), but not
food. receiving supple-
mental foods.
Proposed rule:
Revise the definition for WIC participa-
tion to include the number of
breastfeeding women who receive no
supplemental foods or food instru-
ments but whose breastfed infant(s)
receives supplemental foods or food
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instruments.
¥$
Current rule:
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44833
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
Infants from 4–11 months are eligible for The net effect of these Implementing new May increase sales of Restructures the infant
Food Package II. That food package changes increases procedures, such as infant food and de- package according
includes juice and infant cereal, as the cost of Food setting state policy crease sales of to the recommenda-
well as formula. Package II. on allowed varieties juice and formula if tions of current nu-
of infant food, will participants were trition science. En-
increase short-term not already using courages good in-
administrative bur- the quantities pro- fant feeding prac-
den. posed in the rule. tices. Encourages
Some vendors may consumption of
need to stock addi- fruits and vegeta-
tional infant food va- bles.
rieties that meet the
specific specifica-
tions set by the
states. Vendors will
need to train per-
sonnel to identify
the newly WIC-eligi-
ble infant foods.
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 vegeta-
bles.
4. Reduce maximum formula
amount.
+$
Current rule:
All infants are eligible for the same The cost of the fully Implementing new Increase in sales of Provides added iron
amounts of formula, juice, and infant breastfed package procedures, such as infant food meat is and zinc to the diet
cereal under Food Package II. for infants age six setting state rules likely to be neg- of fully breastfed in-
months and older is on permissible vari- ligible. The number fants age six
increased signifi- eties of infant food of fully breastfed months and older.
cantly. meat, will increase WIC infants age six Also encourages
short-term adminis- months and over is breastfeeding. Both
trative burden. small. Vendors will are consistent with
need to train per- the recommenda-
sonnel to identify tions of current nu-
the newly WIC-eligi- trition science.
ble infant foods.
Proposed rule:
Provide relatively more infant food fruit
and vegetables to fully breastfed in-
fants 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 pre- These changes are The states will incur Sales of low iron for- Disallowing the pre-
scribed with medical documentation. expected to have lit- minimal short-term mula and certain in- scription of low iron
tle effect on the administrative bur- fant cereal varieties formula is supported
foods actually pre- den as they imple- will be reduced by medical re-
scribed to WIC in- ment these minor slightly, if at all, by search. Disallowing
fants. The infant ce- rule changes. these rules. infant cereal with
real rule simply for- added ingredients is
malizes what has consistent with cur-
been federal policy rent, though not for-
since 1980. malized, federal pol-
icy. There should be
jlentini on PROD1PC65 with PROPOSAL2
little if any change
in what participants
can purchase.
2. Infant cereal must be iron-fortified;
WIC regulations contain no other
specifications.
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44834 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
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 ce-
real with added ingredients.
(minimal economic effect)
Current rule:
Children and women with special dietary The rule is intended to The rule is intended to No impact. No direct impact. Im-
needs are prescribed WIC-eligible reduce administra- facilitate program proved service at
medical foods under Food Package tive costs and facili- management. It the state and local
III. Infants with special dietary needs tate program man- may also allow im- level may result, to
are provided exempt infant formula agement. proved service to the benefit of WIC
under Food Packages I or II. WIC beneficiaries. 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 Clarifies who is eligi- The rule may reduce Possible minimal re- Some current partici-
and children with certain dietary re- ble for Food Pack- administrative bur- duction in the sale pants receiving
strictions, but without serious medical age III and what den by eliminating of medical foods Package III may be
conditions, to be prescribed medical foods may be dis- Package III eligibility due to eligibility re- served under food
foods under Food Package III. tributed as part of issues. But, it may quirements. packages more ap-
that package. These require state efforts propriate to their
clarifications are to develop edu- needs.
generally aimed at cational materials
tightening these cri- for local WIC offi-
teria. Will, if any- cials, WIC partici-
thing, reduce Pack- pants, and health
age III costs by care professionals
moving some par- on the eligibility cri-
ticipants to food teria. Will require
packages more ap- local agencies to
propriate for their assist WIC-eligible
needs. But, given individuals in obtain-
the size of the cur- ing the necessary
rent Package III medical documenta-
population (roughly tion for Package III.
1% of all WIC par-
ticipants) these sav-
ings will be small.
Proposed rule:
Clarify language governing the purpose
and scope of Package III eligibility.
¥$
Current rule:
Package III recipients are prescribed This rule will increase Administrative burden May have a small For those Package III
medical foods only; they do not re- costs in those cases of implementing the positive effect on recipients able to
ceive any of the standard food pack- where Food Pack- new rule will be in- the sale of some consume at least
age foods. age III recipients curred in the short secondary WIC some non-Package
are able to con- run. foods. Will not affect III WIC foods, this
sume the foods sales of infant for- rule will provide
contained in the mula. them with additional
regular WIC food food.
packages to which
they would other-
wise be eligible.
But, the Package III
population is small.
The costs will be
jlentini on PROD1PC65 with PROPOSAL2
modest.
Proposed rule:
Make other WIC foods available to
Package III recipients.
+$
Current rule:
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44835
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
Food Packages IV through VII provide The net effect of this The states will need to The rule may result in WIC participants with
WIC beneficiaries with 24 to 28 quarts provision will be a establish new speci- reduced milk and lactose maldigestion
of milk per month. Cheese may be reduction in overall fications and restric- cheese sales to may benefit most by
substituted for milk at a rate of one cost, due to the re- tions for the new WIC participants. It the addition of these
pound per three quarts; cheese may duction in quantities milk substitutes. may lead to in- new substitutes.
replace a total of 12 quarts of milk. allowed and re- They will also incur creased sales of Others with indi-
duced substitution administrative bur- tofu and soy bev- vidual or cultural
amounts. den in implementing erage. Vendors may preferences will also
changes to reflect need to stock new benefit by the
reduced milk pre- items that match the added choices. All
scription maximums specific product re- WIC participants will
and substitution lim- quirements set by benefit from a pack-
its. the states. Rule pro- age lower in satu-
poses nutritional rated and total fat,
standards for soy consistent with the
milk that are cur- recommendations of
rently not met by current nutrition
many products on science.
the market. Be-
cause these stand-
ards will also apply
to the school meals
programs, vendors
are likely to change
fortification so that
the variety of avail-
able soy beverages
that can be author-
ized improves over
time.
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 The fixed dollar values States will need to au- Juice sales to WIC The addition of fruits
Packages IV through VII at maximum of the proposed fruit thorize and develop participants may de- and vegetables to
levels that range from 192 to 336 fl. and vegetable a structure to dis- cline. Sales of fruits the WIC food pack-
oz. per month. vouchers are great- tribute and redeem and vegetables may ages responds to
er than the offset- for fruit and vege- increase. Costs will the recommenda-
ting savings that will table vouchers, be incurred by ven- tions of nutrition
be realized through which will be a new dors as they learn science. And the
reduced juice component of the to accommodate the flexibility of a vouch-
amounts. programs. This ad- new WIC vouchers. er will provide ac-
ministrative burden Some WIC author- cess to a variety of
will be on-going but ized vendors may fruits and vegeta-
part of the current need to add fruits bles, in some form,
banking and MIS and vegetables to year round, in all
systems. State and their stocks in fresh, markets.
local agencies will frozen, or canned
incur administrative form. Emphasis on
burden in devel- fresh fruits and
oping educational vegetables may en-
messages for WIC courage states to
participants con- authorize and par-
cerning the selec- ticipants to shop at
tion of nutritious farmers markets
fruits and vegeta- more often. (See
jlentini on PROD1PC65 with PROPOSAL2
bles. Market Analysis dis-
cussion on page
57).
Proposed rule:
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44836 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
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 Pack- Reducing the max- State and local admin- Market effects will be This proposal reduces
ages IV through VII. States may set imum egg prescrip- istrative burden will minimal. both the food en-
their monthly maximums at either 2 or tion will produce a be incurred in the ergy and fat content
21⁄2 dozen per month. modest reduction in short term as new of the WIC food
food package costs. procedures are put packages. The
That reduction is in place. changes are con-
used to help offset sistent with the ad-
costs of new foods vice of current nutri-
and substitution op- tion science. The
tions. reduction in food
energy also makes
room for the intro-
duction of new
foods that address
priority nutrient
needs.
Proposed rule:
1. Reduce maximum egg prescription in
all food packages for women and chil-
dren.
¥$
Current rule:
There are no restrictions on the fat con- Prescribing only fat re- State and local admin- Market effects will be This proposal reduces
tent allowed in milk. duced milk to istrative burden will minimal. Vendors fat content of the
women and children be incurred in the will need to train WIC food packages.
age two and older short term as new personnel to identify The change is con-
will have a neg- procedures are put the newly WIC-eligi- sistent with the ad-
ligible effect on in place. ble foods. vice of current nutri-
cost. tion 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 The addition of whole State and local agen- Manufacturers may re- The addition of whole
packages for women and children in grain bread to Pack- cies will incur ad- spond by reformu- grains to the WIC
the form of breakfast cereal. Current ages IV, V, and VII ministrative burden lating popular WIC- packages is con-
regulations do not specify a minimum increases the cost to implement the approved cereals in sistent with 2005 Di-
whole grain content for that product. of those packages. new rules. States whole grain form etary Guidelines for
The whole grain re- will incur administra- rather than forfeiting Americans that en-
quirement for the tive burden in es- the WIC market. courage increased
existing cereal com- tablishing specifica- Smaller vendors consumption of
ponent of all food tions and restric- may need to modify these foods.
packages for chil- tions for the new stocks to include
dren and women foods and substi- whole grain bread
will have, at most, a tution options and and cereal varieties.
minor effect on cost. local clinics will All vendors will
incur additional ad- need to train per-
ministrative burden sonnel to readily
to explain food op- identify WIC-eligible
tions to participants. breads and grains.
Proposed rule:
1. Add whole grain bread to Food Pack-
jlentini on PROD1PC65 with PROPOSAL2
ages IV, V, and VII. Allow substi-
tutions of other whole grain foods for
bread.
2. Require that breakfast cereal for chil-
dren and women meet FDA standards
for classification as whole grain food.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44837
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
+$
Current rule:
Dry beans are included in Food Pack- At the proposed rate The proposed option Market effects will be By adding variety and
ages IV, V, and VII. Canned beans of substitution be- will prompt states to minimal. But, as convenience, the
may be prescribed, instead of dry, to tween canned and set specifications with the addition of canned bean option
WIC participants who lack cooking fa- dry beans, the new and restrictions. any WIC substi- should increase the
cilities. option will increase Other short-term ad- tution option, small appeal of that food.
costs. However, the ministrative burden vendors may need It may also encour-
cost of beans in the will be incurred as to add new items to age greater con-
food packages is the new rule is put their stocks, and all sumption, replacing
relatively small and in place. vendors will need to less healthy foods
this change will train personnel to in the diets of WIC
have a relatively identify the newly- participants.
modest effect on eligible WIC foods.
overall program
cost.
Proposed rule:
1. Allow canned beans as a substitute
for dry in all food packages for chil-
dren 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 in- The costs of food Neither of these Minimal market im- These changes sup-
cluded in Food Package VI. Package packages V and VI changes introduce pact. plement the diets of
V currently provides a pound of dry are increased. foods not already breastfeeding and
beans; those can be replaced with 18 included in other postpartum women
oz of peanut butter. WIC packages. The with several of the
administrative bur- priority nutrients
den should be mini- identified by the
mal. 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 exclu- Costs will increase States and local agen- Minimal market im- These changes add
sively breastfeeding women in Food slightly. While the cies will incur ad- pact. But, may force new choices that
Package VII. White, light, or dark new substitution op- ministrative burden small vendors to may encourage
tuna, packed in water or oil, is al- tion may increase in implementation. stock additional consumption. The
lowed. the cost of indi- State agencies will types of canned fish rule also responds
vidual prescriptions, adopt specifications and will require all to medical advice
the number of WIC and restrictions for vendors to train per- that breastfeeding
participants eligible the new substitution sonnel to identify women avoid fish
for Food Package option. newly-eligible WIC species that are
VII is very small. foods. high in mercury.
Proposed rule:
Authorize a variety of canned fish that
do not pose a mercury hazard to fully
breastfeeding women. Slightly in-
crease the maximum amount allowed
to 30 ounces.
jlentini on PROD1PC65 with PROPOSAL2
+$
Current rule:
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44838 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
State WIC agencies impose restrictions This simply clarifies The states are given If states adopt restric- WIC participants may
on some foods by brand or variety in what is already ac- formal approval for tions on the brands need to switch
order to limit cost or ensure statewide cepted policy. The current practice. or varieties of foods brands or varieties
product availability. The practice is ac- policy is an effective The states should newly added to the of foods that they
cepted but not formally authorized by way to control incur little or no ad- WIC food packages, currently consume
regulation. costs. Since the rule ministrative burden then participants to brands and vari-
represents no in implementation. who already pur- eties consistent with
change from current chase those foods those added to the
practice, it results in may switch their se- WIC packages.
no economic im- lection of brands or
pact. varieties to the
WIC-approved
choices. A measur-
able shift in con-
sumption by brand
or variety may re-
sult.
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 Assures more con- The rule reduces the Minimal effect on ven- Assures more con-
to WIC participants in quantities that sistent WIC benefits level of work cur- dors and producers. sistent WIC benefits
are less than the package maximums are delivered across rently undertaken by are delivered across
when nutritionally warranted. The states. state officials. Ad- states. IOM has
states may also standardize these re- ministrative burden based food pre-
ductions and apply the reduced will decrease to the scription quantities
amounts consistently to like groups of extent that states on current nutri-
WIC participants. Such categorical will not undertake tional science ren-
food package tailoring may be done their own review of dering food package
for nutritional reasons, but not to WIC prescription tailoring unneces-
achieve cost reductions. maximums in re- sary.
sponse to the fed-
eral revisions to the
WIC food packages.
In the absence of
this rule, the states
may have incurred
administrative bur-
den.
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 Minimal cost given the States may incur Unless manufacturers Will ensure WIC par-
next whole container of infant foods if small container some administrative change container ticipants get the full
needed to provide the maximum au- sizes involved. burden to imple- sizes to achieve nutritional benefit
thorized amount of these foods. Rounding up is like- ment, particularly if greater product authorized.
ly to require the ad- manufacturers sales, no impact is
dition of little jarred change container expected.
infant food to the sizes in response to
food packages; con- this rule.
tainers are typically
just 4 oz. The cur-
rent infant cereal
maximum of 24 oz
is a multiple of a
commonly pre-
scribed package
size; 8 oz boxes are
among the standard
jlentini on PROD1PC65 with PROPOSAL2
package sizes.
Proposed rule:
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44839
TABLE 2.—SUMMARY OF KEY PROVISIONS—Continued
Effect of proposed rule on
Current and proposed rules
USDA/federal gov’t State/local agencies Vendors/industry WIC participants
End state practice of requesting addi- Will reduce adminis- Because of the pro- Minimal since very Minimal since very
tional package substitutions. A proc- trative costs of con- posed rule’s flexi- few food package few food package
ess is currently in place to accept and sidering proposals bility in food offer- substitutions have substitutions have
evaluate requests by state WIC agen- but little affect on ings, states will no ever been per- ever been per-
cies to add new foods to the pro- program costs since longer have as mitted. mitted.
gram’s list of allowed substitutes. very few package much, if any, need
substitutions have to request substi-
ever been ap- tutions to meet cul-
proved. tural preferences.
Administrative sav-
ings will accrue for
those states that
would have pursued
substitutions in the
absence of this rule.
D. Costs cost savings of $34 million dollars over five food costs; no additional funds will be
1. Proposed Rule years. provided to states or local clinics to
The economic effects of the proposed rule implement this rule. The costs have been
Under the proposed rule, FNS estimates on the federal government over a five-year adjusted for the rule’s phased-
that the revisions to the WIC food packages period are summarized in Table 3, which implementation schedule. Current and
will be cost-neutral. Specifically, FNS presents the impacts of the revisions by food proposed food package costs are provided in
estimates that the changes will result in a package type. These figures are limited to Tables A1–A3 in the appendix.
TABLE 3.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS
[In millions]
FY 2007–
Food package FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 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 reflect total food costs and savings. Total adjusted for the rule’s phased
each food package; provisions listed do not costs are for FY07–FY11 and have not been 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 in-
fants (¥$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).
jlentini on PROD1PC65 with PROPOSAL2
• Cheese is reduced (¥$638 million).
• Eggs are reduced (¥$290 million).
• Beans added (+ $130 million).
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44840 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
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 under the revised food package rules. FNS Participants prescribed one of the new
Due to the seasonal fluctuation in price will use later year data to project cost substitutes will be provided with the
and availability of fresh fruits and vegetables, changes if it becomes available before the maximum allowed under the proposed rule
and the inability to purchase them in final rule. FNS developed a micro-simulation given any other substitutions allowed.
uniform weight units, it is difficult to set program to model participant-specific • Fruit and vegetable vouchers are
quantity terms for fruits and vegetables and prescription amounts for each of the foods in assumed to be prescribed to all participants
still estimate the cost of the WIC food the proposed packages other than infant at the full amount.
packages. In order to accurately capture the formula. The following assumptions guided This methodology tends to produce
cost of providing fresh fruits and vegetables this analysis :42 prescription estimates that are at or near the
in WIC Food Packages III–VII, the proposed • For foods that are part of both the current maximum quantities allowed under the
rule includes fruit and vegetable vouchers. WIC packages and the revised packages: revised packages. (See Table 5.) That
Due to the administrative ease of • WIC participants currently prescribed outcome is consistent with the proposed
implementation, the IOM recommended none of that food will continue to be rule?s recommendation that participants be
cash-value instruments be issued.40 The IOM prescribed none. issued prescriptions at the package
also recommended that states provide fruit • If the participant’s current prescription maximums. It is also consistent with the rule
and vegetable vouchers at the level of $10 per exceeds the proposed maximum for the item, that would end categorical tailoring.
month for women and $8 per month for then the participant will be prescribed the ii. Infant Formula and Rounding. In this
children. However, to achieve cost neutrality new maximum amount. analysis, infant formula and infant foods
with the proposed changes, FNS set the • If the participant’s current prescription is were treated slightly differently than the
vouchers at the level of $8 per month for less than the proposed maximum, then the other foods. Using a micro-simulation
women and $6 per month for children in the participant’s prescription will remain program with PC2002 data to model
year in which the proposed food package unchanged. prescription amounts for infant formula and
revisions take effect. The maximum amount • For foods newly added to the WIC foods would not account for ‘‘rounding up’’.
of the vouchers would be adjusted to reflect packages by the proposed rule: Rounding up refers to the ability of state
inflation in whole dollar increments. agencies to round up to the next whole
• Generally, prescription rates are set to
3. Cost Estimate Methodology observed rates for comparable foods already container to provide the maximum infant
contained in the WIC packages.43 formula allowance. This option is only
a. Food costs. i. Prescriptions. The states
• Foods newly added to the WIC packages available for state agencies which renew its
report participant-level food prescription
as substitutes for standard WIC foods were infant formula contract on or after October 1,
data to FNS on a biennial basis. A statistical
prescribed to a subset of the WIC population 2004. The proposed rule extends this
sample drawn from those state records was
used in preparing this cost estimate. At the equal to the percent of all low income U.S. rounding option to infant foods (cereal, fruit
time of this analysis, the 2002 prescription and vegetables, and meat).
households that currently purchase those
dataset was the most current available. The Since the PC2002 data do not reflect the
items.44 For example, market consumption
dataset records the April, 2002 prescription costs of states rounding up, the cost estimates
data indicates that about 3% of U.S.
of WIC foods to each participant who of the current and proposed packages use a
households with WIC-eligible incomes
received a package that month.41 FNS used different approach to factor in the cost of
purchased tofu, so 3% of WIC participants
the 2002 prescription data to establish a states rounding up. Given current container
are assumed to be prescribed tofu.45
baseline food cost and to estimate the costs sizes, rounding up is only required when
of the proposed package revisions. Actual 42 The description that follows is a simplification
issuing powder infant formula and infant
participant-level prescriptions provide a fruit and vegetables. The maximum
of the process used to develop the estimated
useful starting point for this analysis. Data at prescriptions. allowances for liquid concentrate infant
the participant level captures the preferences 43 Prescription rates for whole grain bread and formula, ready-to-feed infant formula, infant
and dietary restrictions of the current WIC bread substitutes are set to the observed cereal and infant meat are evenly divisible by
population. Assuming little change in the prescription rates for cereal; the April 2002 Food whole containers. To capture the effect of
distribution of the WIC population by life Package IV cereal prescription rate was applied to rounding, the following assumptions have
stage, food preference, or supplemental Package IV bread prescriptions, the Package V been made:
dietary need over the short term, the 2002 cereal prescription rate was applied to Package V • Current Food Packages I and II
bread prescriptions, etc. • Estimated prescription infant formula
prescription data offers the best opportunity 44 Market consumption data is based on 2003 AC
amounts for Packages I and II BF/FF
jlentini on PROD1PC65 with PROPOSAL2
for estimating likely prescription amounts Nielsen Homescan survey data.
45 This method of identifying general consumer
(partially breastfed) and I and II BF
40 40 IOM, p. 172. (breastfed) do not incorporate rounding as
preferences for particular items cannot be used to
41 The Participant Characteristics, ‘‘PC2002’’, estimate the share of the infant population that the estimated amounts fall below the
dataset contains prescription data from 49 states, consumes fresh bananas. It is assumed, then, that
PR, D.C., several U.S. territories, and separately infants will be prescribed bananas as a substitute average prescription rate for all foods across all food
administered Native American WIC agencies. for jarred infant food fruits and vegetables at the packages.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44841
maximum amounts. Estimated prescription • Total infant formula allowance for each estimated average prescribed amounts used
amounts for Packages I and II FF (fully package is weighted by the percentage of to calculate costs for the food packages under
formula-fed) are set at the maximum amounts infants receiving each of the three forms the proposed rule and under the current rule,
of 806 reconstituted liquid ounces for liquid (liquid concentrate, ready to feed, and respectively. Each table includes the
concentrate and ready to feed infant powder) as distributed in the PC 2002 data. individual food package component and its
formulas; for powder infant formula the • Infant Foods:
current 8 pound limit is used. • Only Package II has infant foods. corresponding unit of measurement.
• The reconstituted fluid ounces from Container sizes are based on IOM WIC foods are provided by quantity, except
powder infant formula is a weighted average assumptions: infant fruits and vegetables for the fruit and vegetable voucher. As stated
of the powder container yield for the three amounts are determined using Gerber in the proposed rule, participants will be
infant formula brands with which state container sizes weighted over the 6 month given a fruit and vegetable voucher with a
agencies have rebate contracts: Mead package period; current infant cereal fixed dollar value which can be used to
Johnson, Ross and Nestle (as determined by containers (8 oz) and infant meat containers purchase fruit and vegetables. Because the
state agency contracts as of January 2006). (2.5 oz) meet maximum monthly allowance proposed fruit and vegetable voucher
• Total infant formula allowance for each without the need to round up.46
provides WIC benefits in a different form
package is weighted by the percentage of • Bananas are allowed to be substituted for
infants receiving each of the three forms infant fruit at the rate of 2 pounds per 16 than is currently used, different redemption
(liquid concentrate, ready to feed, and ounces of fruit. The proposed packages cost behavior is to be expected. Therefore, in
powder) as distributed in the PC2002 data. estimate assumes 1.8 pounds of bananas as developing a cost estimate for the rule, it is
• Proposed Food Packages I and II substitution. assumed that these vouchers will be
• Infant Formula: The proposed rule requires state agencies redeemed at a rate of 87.5 percent, which is
• All packages are set at the maximum to issue at least the full nutritional benefit of consistent with an evaluation of a WIC fruit
monthly allowance for liquid concentrate, infant formula but not more than the and vegetable intervention in Los Angeles in
ready to feed and powder infant formulas as maximum monthly allowance for the food 2004.47 Per participant, a redemption value
detailed in the proposed rule. package category and infant feeding option.
of $5.25 for children and $7.00 for women
• Powder infant formula is rounded to However, rounding up to the whole container
meet the maximum monthly reconstituted to meet the maximum monthly allowance was included in the cost of the respective
liquid concentrate allowance, but to not provides more containers per month, which food package.
exceed the maximum monthly powder infant in turn results in higher costs. In addition, All other WIC foods are assumed to be
formula limit. under both the current and proposed redeemed at a 100% rate. The assumption of
• The reconstituted fluid ounces from packages, the roundup provision is assumed 100% redemption rates for other WIC foods
powder infant formula is a weighted average to apply in all states at full implementation reflects research findings which indicate that
of the powder container yield for the three beginning in FY07. Therefore, this analysis redemption rates for current WIC foods are
formula brands with which state agencies provides the most conservative estimate of high and vary little by food item (ranging
have rebate contracts: Mead Johnson, Ross the additional cost due to rounding, as there
from 94–99 percent).48 Variation in the
and Nestle (as determined by state agency is no way to accurately determine which
contracts as of January 2006). states will elect to include a roundup quantity of foods purchased by participants
• Proposed Food Package I BF/FF–A provision in their infant formula rebate is reflected in the prescription rates. Thus a
assumes 100 percent powder infant formula. contract. simplifying assumption of 100 percent
This is consistent with IOM iii. Redemption rates. Tables 5 and 6 show redemption rates was used for WIC food
recommendations. the maximum amount per food category and prescribed by quantity.
TABLE 5.—PRESCRIPTION ESTIMATES UNDER PROPOSED RULE 49
Estimated
Maximum average
Food package Units 50 amount per prescribed
food category 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
jlentini on PROD1PC65 with PROPOSAL2
Cereal .................................................................... oz ................................................................................ 24 20.10
46 The prescription rates for infant cereal, fruit container sizes; that factor is reflected in the Quality among WIC participants and their
and vegetables, and meat are set to the average estimated prescribed amount. Families?’’ ERS, USDA, 2004. DRAFT.
prescription rate of juice across all of the women’s 47 Herman, Dena and Harrison, Gail, ‘‘Are 48 Food and Nutrition Service, U.S. Department of
food packages. Only infant fruit and vegetables Economic Incentives Useful for Improving Dietary Agriculture, ‘‘National Survey of WIC Participants’’,
were subject to rounding up due to the current October 2001.
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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
Estimated
Maximum average
Food package Units 50 amount per prescribed
food category 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
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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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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44843
TABLE 5.—PRESCRIPTION ESTIMATES UNDER PROPOSED RULE 49—Continued
Estimated
Maximum average
Food package Units 50 amount per prescribed
food category 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
Estimated
Maximum average
Food package Units 52 amount per prescribed
food category 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
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Juice ...................................................................... oz ................................................................................ 96 76.42
Cereal .................................................................... oz ................................................................................ 24 20.27
Children: Food Package IV
IV:
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44844 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 6.—PRESCRIPTION ESTIMATES FOR CURRENT FOOD PACKAGES—Continued
Estimated
Maximum average
Food package Units 52 amount per prescribed
food category 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 averages weighted by the relative purchase available. For years after FY 2004, food costs
in the current or proposed packages, FNS volumes of the selected product varieties. are inflated by the Office of Management and
estimated the average price paid by Product descriptions captured by Nielsen Budget’s June, 2005 Thrifty Food Plan (TFP)
households with WIC-eligible incomes. sometimes lack the detail necessary to index except for the fruit and vegetable
These prices are based on 2003 retail sales separate WIC-eligible items from non-eligible vouchers which are inflated by the USDA’s
data collected by AC Nielsen.53 All prices are items. For this reason, the selection of agricultural baseline projections for retail
products from the Nielsen datasets
fruit and vegetable prices. (See Tables B and
necessitates some compromise. The average
49 The only significant change to Food Package III C in the Appendix for more detail.)
prices computed by FNS and a brief
in the proposed rule is the proposed addition of
description of FNS’ product selection criteria In each case, prices are computed only for
foods to these recipients’ packages when their products in container sizes consistent with
medical circumstances allow it. The PC2002 data
are shown in Table 7.
Food prices obtained from AC Nielsen current WIC regulations, typical state agency
set indicates that about 1 percent of WIC
participants receive Food Package III. FNS assumes Homescan data are inflated to FY 2004 levels requirements, or the proposed rule. Products
that half of them will be able to and will choose with CPI estimates published by Bureau of identified as organic were excluded; states
to receive all of the other foods available to them Labor statistics.54 Food item or category typically disallow organic varieties for cost
under the proposed rule. Therefore, we do not specific inflation estimates were used, when reasons. FNS also adjusted the WIC food
calculate prescription rates for Food Package III. prices for fiscal years 2005 and 2006 to
50 Units are expressed in: Fluid ounces (fluid oz);
53 FNS computed average prices for all food items account for changes in the infant formula
ounces (oz); pounds (lb); quarts (qt); and, dozens other than infant formula from calendar year 2003 market (e.g., many State agencies are now
jlentini on PROD1PC65 with PROPOSAL2
(doz). AC Nielsen Homescan data. A price for infant
51 Prescribed amount for fruit and vegetable prescribing infant formulas enhanced with
formula was estimated from FY 2004 Nielsen
vouchers is the redemption rate as discussed in supermarket scanner data. Prices displayed below DHA/ARA, which have tended to cost WIC
4a(iii) within this section. are inflated to FY 2004 levels using Bureau of Labor more than non-enhanced infant formulas).
52 Units are expressed in fluid ounces (fluid oz), statistics CPI estimates.
ounces (oz), pounds (lb), quarts (qt), and dozens 54 2004 price data became available in 2006 after
(doz). this analysis was completed.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44845
TABLE 7.—WIC FOODS: FOOD ITEM, SELECTION CRITERIA, UNITS, AND PRICES PER UNIT
Price per unit
Food item Retail sales database selection criteria Units (inflated to FY
04)
Infant formula (post rebate):
Powdered ............................................................... Standard and enhanced formula 55 in powdered, liq- oz .................... $0.026
uid concentrate, and ready-to-feed forms.
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. qt ..................... 0.746
Reduced fat includes skim milk and milk identified
as 2% or lower milkfat.
Reduced fat ........................................................... ..................................................................................... qt ..................... 0.675
Cheese .......................................................................... Processed American and domestic natural cheddar, lb ..................... 3.557
colby, mozzarella, brick, Monterey jack. Sliced or
unsliced varieties.
Tofu ............................................................................... Plain varieties ............................................................. lb ..................... 1.689
Soy beverage ................................................................ Quart or larger sizes. Plain varieties .......................... qt ..................... 1.940
Juice .............................................................................. Apple, grape, orange, grapefruit, tomato. Unsweet- oz .................... 0.031
ened 100% juice.
Adult cereal:
Whole grain ........................................................... Name brands (and their generic versions) commonly oz .................... 0.151
prescribed by state WIC agencies.
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 lb ..................... 0.728
peas. Not mixed with other foods.
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 feeding practices change. This is consistent As shown in Table F in the Appendix,
level of WIC participation through FY 2011 with the analysis provided by IOM. most of the rule’s provisions are phased-in
are those used in developing WIC program The assumption of no change in over the course of a year. The elimination of
costs for the President’s FY06 Midsession breastfeeding patterns yield the most juice from the infant food packages, however,
Budget. Those projections assume continued conservative cost estimate, as the net impact is phased-in six months from publication of
participant growth at the average rate of increases in breastfed infants and the rule.
observed over the past four years. Consistent breastfeeding women participants reduces The IOM recommended pilot testing or
with the IOM assumptions, we do not assume the costs of this proposal. IOM conducted a limited application of certain changes before
any changes in participation under the sensitivity analysis by simulating possible full scale implementation. The limited
proposed rule due to potential participants shifts in participation rates. Shifting infant/ application option was chosen because FNS
finding the revised package more or less mother pairs from the fully formula-fed does not have the authority to conduct pilots
attractive. (For more detail on participation package to the breastfeeding packages has the that waive current regulations. The rule’s
levels by food package see Tables D and E in effect of moving infant/mother pairs from the implementation plan addresses the IOM
the Appendix.) most expensive set of packages to less recommendation for testing of certain
Many of the proposed package changes expensive ones. A constant shift of 30 provisions while allowing State agencies
were intended to encourage breastfeeding. percent for one to 11 months of age from sufficient time and broad flexibility to
However, it is important to note that this partial to full breastfeeding and a smaller implement the majority of the food packages.
analysis does not provide an estimate of the range of shifts from full formula feeding to Key provisions of the rule intended to
increase in the number infants or the full breastfeeding (with an appropriate shift promote breastfeeding will be implemented
additional length of time that infants will be in the mother’s classification) decreased the initially in no more than 32 local test sites
breastfed. Due to the complex set of factors in up to eight states. Those provisions will
average package cost by nearly two percent.56
(demographic, clinical, etc.) that influence not be implemented nationwide until FNS
vi. Phased implementation. The analysis
breastfeeding duration, we are unable to has evaluated their effectiveness at the test
assumes the rule takes effect on November,
estimate the number of infants/mother pairs sites. One such provision is that breastfed
2006. State agencies would be required to infants under one month old do not receive
that will switch food packages as their issue food benefits based on either the new formula from the WIC Program. Another is
jlentini on PROD1PC65 with PROPOSAL2
food packages or current food packages but the provision that conditions eligibility for
55 The term ‘‘standard infant formula’’ refers to
could not combine the two. State agencies Food Packages V and VI on the level of infant
both milk-based and soy-based infant formulas, may also phase-in new food packages on a
excluding specialized infant formula (i.e. formula formula prescribed to the mother. However
participant category basis. as noted, the breastfeeding promotion
for infants or children with special dietary needs).
‘‘Enhanced formula’’ are formulas that have been provisions of the rule cannot be estimated
enhanced with two fatty acids, DHA and ARA. 56 See IOM, p. 140. with confidence. Due to the indefinite
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44846 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
timeline for full implementation for the test implement this rule without receiving NSA rule, there may be some ongoing
sites ensure that the near term cost of the funds beyond what they would have received administrative requirements to ensure that
breastfeeding promotion provisions will be in the absence of this rule. However, we WIC staff, vendors and participants
minimal, the key provisions in the rule believe that the administrative burden understand and properly implement the
intended to promote breastfeeding have been associated with implementing this rule can changes. States will need to continuously
factored into this rule with the same phase- be absorbed within current funding review all of the food package changes and
in schedule as the other provisions. constraints. consider a broader range of issues in
All phase-in effects are reflected in the cost As part of its analysis, IOM held open
determining their strategies for containing
estimates contained in Table 3. Juice sessions to solicit State and local agencies,
practitioners and experts for comment on the costs. The increase in the number of food
prescriptions under the revised infant food
current and proposed packages. Participants items and flexibility afforded to participants
packages will be reduced linearly from
current levels to zero in the six months supported the changes in the food packages, will impact time spent on providing
following the rule’s effective date. but also acknowledged the administrative education and support materials on food
Nationwide, the juice prescription over that burden that may arise. Specific selection, storage and preparation. Many of
six month period will average half the level administrative burden for each proposed the changes in this rule are designed to
that would have been forecast under existing revision is identified in the Summary of Key support breastfeeding and local clinics may
WIC rules. Elimination of juice from the Provisions on page 23 of this analysis. make ongoing changes in staffing and
infant food packages would reduce program FNS does not have data on the current materials to reinforce the changes in the food
costs by $30.1 million in FY 2007 if the administrative costs incurred by state and packages with breastfeeding counseling and
provision were made fully effective upon local agencies. Therefore, we are unable to support. In addition, time will be spent
implementation of the rule. The six month quantify the potential increases in communicating with and monitoring vendors
phased elimination of juice will reduce those administrative burden due to the proposed to ensure compliance may increase.
FY 2007 savings by an estimated $8.3 revisions. The proposed rule asks for WIC vendors will also be affected. Vendors
million. comments from State and local agencies on will need to train their personnel to
This analysis assumes that the remaining the scale of the administrative burden
recognize the newly WIC-eligible foods and
provisions of the rule will be phased-in over associated with implementation of the
to handle the new fruit and vegetable
the course of the year that begins November, revisions.
Generally, states and local clinics may vouchers. Training time may increase due to
2006. It is assumed, as above, that states will the expanded lists of foods, and management
implement the provisions of the rule need to reprioritize or postpone some
initiatives to undertake some of the start-up information system changes may be
throughout the phase-in period; the effective necessary. Vendors may also need to revise
rate of implementation is assumed to average activities associated with this rule, as well as
adapt to certain ongoing administrative their practices to meet the stocking
50% over the year. 57 The rule’s phase-in
requirements resulting from the rule. requirements dictated by the new food
schedule reduces these costs by half in FY
2007 to $21.1 million. FY 2008 costs are Initially, State and local agencies will need packages. Most large vendors already carry
reduced by an estimated $0.3 million. to revise state lists of authorized foods and all of the newly-eligible foods; however,
vii. State cost variation. This analysis is prescribed amounts, develop food package some smaller vendors may decide that it is
based on national average prescription and combinations, and create a fruit and not worth participation in WIC to stock the
price data, which indicates that program- vegetable cash-value voucher to accompany newer foods. We do not believe that these
the standard WIC instruments. State agencies expenditures will be significant enough to
wide, the proposed changes are cost neutral.
will need to review and update all of their cause many current vendors to discontinue
States may vary somewhat in their
guidance materials regarding authorized their voluntary participation in the WIC
implementation experiences, depending on
supplemental foods. Significant time during program.
how closely their prescription practices and
implementation will be required in order to
prices correspond to the national averages. train staff on the changes in the WIC food E. Uncertainties
WIC funding rules help address these packages. Staff will need to work with
implementation issues. The food funding The estimate developed above is sensitive
manufacturers and vendors to evaluate
formula provides mechanisms for to changes in several key assumptions. A few
newly-eligible foods for nutrient content,
transferring funds from states which are not of the most significant are discussed here.
determine minimum stock requirements,
fully utilizing their grants to those with need identify any special needs for carrying foods, 1. Price Volatility in the Dairy Market
for additional funding, and these such as increased shelf space or refrigerator
mechanisms have been successfully used in Instability in dairy prices over the last
space, and ensure systems are in place to several years presents a major element of
the past to address variations in states’ accept the fruit and vegetable vouchers. State
funding needs. uncertainty in the cost estimate. However,
and local agencies will need to modify their
b. Administrative costs. WIC state agencies the maximum amount of milk available in
existing WIC food management information
receive an annual nutrition services and systems to allow the new foods to be each of the food packages is reduced. The
administration (NSA) grant to help pay the prescribed and to process the fruit and total amount of milk that can be replaced
administrative costs of operating the WIC vegetable vouchers. Expenditures related to with more expensive substitutes has been
program. Each state agency’s NSA grant is management information systems, and the reduced as well. These factors make the
determined by a statutorily-defined formula degree to which any this impact is one-time revised food packages less sensitive to dairy
that is adjusted annually for inflation and or ongoing, will vary based on the State and price fluctuations than the current WIC
other factors. This rule does not propose any local agency’s current database structure. packages. A 10% increase in the price of milk
change to the NSA funding formula. FNS In addition to the administrative efforts and cheese would alter the cost of the revised
expects State and local agencies to associated with initial implementation of the 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
jlentini on PROD1PC65 with PROPOSAL2
Total Cost of Proposed Rule ................................................................... ¥0.8 2.7 ¥7.9 ¥19.5 ¥8.7 ¥34.2
57 If the phase-in rate increases linearly over the approximation, it is assumed that the effective rate in the first month of FY 2008 (the last month of the
first year, the rule would not be fully effective until of implementation throughout FY 2007 averages phase-in period) is 11/12.
the second month of FY 2008. As a rough 50%, and that the effective rate of implementation
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44847
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 substitute, without regard to cost, a natural analysis, 8.7% of all milk and milk
Beverage response is consumption at a rate above the substitutes prescribed to women is in the
FNS anticipates that 10% of women will rate of those whose choice between the two form of soy beverage. FNS’ methodology,
products does not have personal cost impact. which incorporates the more detailed data
request soy beverage in place of liquid milk,
FNS identified each of the women on its available from PC2002, results in a somewhat
if provided the choice. AC Nielsen Homescan
2002 WIC prescription dataset who were lower 7.8% substitution rate for soy beverage.
data indicate that approximately 10% of
provided neither milk nor cheese. Those Adequate data on which to base a soy
households with WIC-eligible incomes individuals, as a group, are assumed to be the
purchased some soy beverage during FY beverage consumption rate for adult women
WIC participants most inclined to request a
2003. The IOM cites high rates of lactose is not available; it is not known whether
prescription of soy beverage in place of milk.
maldigestion and low rates of cultural consumption is appreciably higher or lower
FNS’ simulation model prescribes an amount
acceptability of milk among African of soy beverage to those individuals equal to among women than among the population
American and Asian women as important the maximum allowed under their respective generally. For these reasons, the cost of the
factors in its decision to introduce substitutes food packages. The program then substitutes proposed rule has been re-estimated using
for milk.58 African American women are soy beverage for the existing milk two alternate assumptions. If soy beverage is
represented in the WIC population at a level prescriptions of other WIC participants to the prescribed to only 5% of women, the average
disproportionate to their share of the general extent necessary to reach the 10% participant package V, VI, and VII soy beverage
population. In part for that reason, it is target. The program prescribes cheese and substitution rate is 3.9%. Conversely if soy
appropriate to assume a WIC participant tofu before soy beverage; it does not replace beverage is prescribed to 15% of women, the
preference for soy beverage is at or near the the prescription of those milk substitutes average package V, VI, and VII soy beverage
upper range of estimates of soy beverage with soy beverage. IOM took a similar substitution rate is 11.5%. Given the high
consumption in the U.S. as a whole. And approach in developing its cost estimate; it cost of soy beverage relative to milk, these
because WIC participants may choose freely assumed that soy beverage would replace alternate scenarios would have has cost
between milk and the more expensive soy 10% of liquid milk prescriptions. In IOM’s 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 new milk substitutes to help ensure adequate cheese and soy beverages up to the IOM
FNS considered several alternatives to the calcium intake by those who cannot consume maximum substitution level. As shown in
proposed rule. These alternatives are milk and to accommodate cultural Table 10, the price of yogurt, $2.62 per quart,
discussed below. Each of these alternatives preferences. Under the current rule cheese is as compared to $.68 per quart for milk,
was ultimately rejected because FNS believes also available as a milk substitute for up to considerably increases the monthly cost of
that a food package which reflects the IOM three quarts of milk. IOM’s recommendation
specifically called for limiting substitutions Food Packages IV–VII. Soy beverage and tofu
recommendations as closely as possible also have higher per unit costs than milk;
within the constraint of cost neutrality best of cheese, yogurt, and tofu to four quarts of
milk for Food Packages IV, V and VI, and six however, the estimated amount of tofu
reflects current scientific consensus on how
to best meet the dietary needs of WIC quarts of milk for Food Package VII. Soy purchased by WIC participants is
participants. beverage would be allowed for the entire substantially lower than that of yogurt, and
milk allowance for Food Packages V, VI, and soy beverage can serve as an alternative for
1. Include Yogurt as a Milk Substitute for VII.
Food Packages IV–VII all or part of the fluid milk for adult women
In order to maintain cost-neutrality, the making it a more cost-efficient substitute.
For Food Packages IV–VII, the IOM proposed rule eliminates yogurt as a milk
identified yogurt, tofu, and soy beverage as substitute, but allows the substitution of tofu,
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58 IOM, p. 119.
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44848 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 10.—PROJECTED COST OF YOGURT AS A MILK SUBSTITUTE
Estimated
average Price per unit Cost per food
Food package prescribed (inflated to package
amount FY04)
(qt.)
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 The five year cost of the rule, as modified by the proposed rule without yogurt is $¥34.2
as a milk substitute is shown in Table 11. this alternative, is $605.7 million. The cost of 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 A and C as priority nutrients lacking in the dark orange vegetables replace the current
Vegetable Provision With a More Restrictive diets of some WIC subpopulations, the IOM allowance of 2 pounds of carrots in Food
Dark Green and Orange Vegetable Rule chose not to emphasize the dark green and Package VII. Allowable forms include fresh,
The 2005 Dietary Guidelines for Americans orange vegetable groups that tend to offer the canned, and frozen vegetables. This
stresses the importance of consuming highest concentrations of those nutrients.61 alternative allows substitution at a one-to-one
vegetables from each of five identified Instead, the IOM recommended a fruit and rate, for example, one 16 ounce can per 1
subgroups (dark green, orange, starchy, vegetable option with few restrictions. Under pound of fresh vegetables and 1 pound frozen
legumes, and ‘‘all other.’’) Overall the proposed rule, nutrition education
for 1 pound fresh. In order to contain costs
consumption of vegetables by American offered by local WIC agencies will remain the
and administrative burden, as well as to
adults tends to fall short of the levels primary method of encouraging participants
to the most nutritious fruit and vegetable maintain the nutrient density of the food
recommended by the 2005 Dietary packages, the following are disallowed:
Guidelines for Americans.59 But inadequate varieties; participants remain largely free to
choose the fruits and vegetables that they creamed or sauced vegetables; vegetable-
consumption varies by vegetable subgroup. grain (e.g. pasta/rice) mixtures; mixed
Consumption of vegetables from the dark find most appealing.
An alternative rule that excluded fruit from vegetables that include non-authorized
green, orange, and legume groups fall farthest
from recommended levels.60 the WIC packages and limited vegetable vegetables; breaded vegetables; fresh
The current WIC food packages address choices to nutrient-dense dark green and vegetables prepared for immediate
inadequate consumption of legumes through orange varieties would increase the level of consumption such as those cleaned and
the prescription of dried beans and peanut priority nutrients offered by the revised food chopped on salad bars; baby vegetables; and,
butter and the proposed rule would increase packages. A restrictive vegetable rule might those packaged in individual servings except
the quantity of those items in two of the food also reduce the inefficiency costs incurred by for homeless participants. These fruits and
packages. The rule also attempts to increase retailers as WIC participants mistakenly bring vegetables would only be prescribed to those
the appeal of the legume subgroup by non-WIC items to the checkout counter. A Food Package III participants who do not
providing a canned option in packages IV small and definite list of WIC approved have a medical condition that would
through VII. vegetables would allow retailers to affix preclude consumption of leafy green or dark
By contrast, the current WIC packages and labels to store shelves pointing WIC orange vegetables.
the proposed revisions might appear to give participants to each of their options. The Cost is not an impediment to a limited,
too little attention to the lack of dark green same cannot be done as readily if the IOM nutrient-dense vegetable option. Broccoli,
and orange vegetables in the typical recommended and USDA proposed approach
carrots, mustard greens, kale, sweet potatoes,
American diet. The current WIC food is adopted. Although the rule offers
and spinach are among the least expensive
packages offer no vegetables from the dark substantial consumer choice, it also comes
fresh vegetables on a per serving basis, and
green subgroup to any participant; carrots with significant restrictions on product form,
especially for processed fruits and vegetables. are prime candidates for inclusion in any list
provided to breastfeeding women are the
only vegetables from the orange subgroup Specifically, this alternative would of nutrient-dense, dark green and orange
currently offered through WIC. Development provide, in Food Packages III–VII, 3.75 vegetables.62 Collard and turnip greens are
of the proposed rule presented the IOM and pounds or 60 ounces of the following leafy among the least expensive vegetables
the USDA with an opportunity to add green or dark orange vegetables: broccoli; available in frozen form.63
vegetables from these subgroups to the WIC carrots; leafy greens (kale, mustard, collard, Table 12 summarizes price per serving, and
packages. Perhaps surprisingly, the rule does turnip, spinach); sweet potatoes; and winter the total number of servings purchased, for
not prescribe a specific quantity of vegetables squash (i.e. Hubbard, acorn or butternut) in several common vegetables.64 Dark green
from either of these subgroups. Despite lieu of the fruit and vegetable voucher. Three leafy vegetables and deep orange vegetables
jlentini on PROD1PC65 with PROPOSAL2
recognizing potassium, folate, and vitamins and three quarters pounds of leafy greens or are highlighted.
59 USDHHS/USDA, p. 4. Vegetables?, Economic Research Service, U.S. all of the dark green and orange vegetables are
60 Id. Department of Agriculture, July 2004, p. 33. displayed. Prices are averages over all forms (fresh,
61 USDHHS/USDA, p. 26. 63 Id. frozen, canned, etc.) weighted by the number of
62 Jane ˜
Reed, Elizabeth Frazao, Rachel Itskowitz, 64 ERS examined thirty common vegetables. The servings purchased by form.
How Much Do Americans Pay for Fruits and top ten by each measure (price and quantity), plus
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44849
TABLE 12.—COMMONLY CONSUMED VEGETABLES, 1999: PRICE PER SERVING AND SERVINGS PURCHASED
Price per serving Servings purchased
Rank Rank
Vegetable Dollars Vegetable Billions
(lowest = 1) (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, The overall cost of the proposed rule The cost of the proposed rule, without
and canned) five of the nine dark green and would be significantly reduced if modified to modification or additional cost containment
orange vegetables are available at prices restrict consumption of vegetables to dark discussed above, is $¥34.2 million (see
below the 30 vegetable average. But just two green and orange vegetables with a 3.75 Table 3.)
of them are purchased at above average rates; pound maximum quantity. The five year cost
the rest are purchased at rates well below of the rule, as modified by this alternative,
average. is $¥702.4 million as shown in Table 13.
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 participants to increase their intake of those reduce the excess intake of food energy and
vegetables raises two concerns. The first is nutrients. IOM concluded that participant saturated fat. IOM and USDA propose a
whether vendors will be willing to stock choice is among the keys to increased minimally restrictive fruit and vegetable
vegetables with such limited appeal. consumption of priority foods and option with the expectation that it will
Historically, WIC has included only nutrients.65 Concluding that food package increase consumption of targeted nutrients,
commonly consumed and widely available options with limited choice fail to provide and improve the diets of WIC participants,
items in its food packages. These ‘‘incentives for participation,’’ IOM suggests more effectively than a limited vegetable
considerations serve, in part, to limit the that poorly designed food packages may option with less participant appeal.
costs incurred by WIC-approved vendors. prevent WIC from reaching some at-risk 3. Do Not Offer Infant Food Fruits,
Requiring vendors to maintain fixed supplies populations at all.66 Vegetables, or Meat to Infants Age Six
of little-consumed foods may prove too A rule that allows wide choice among Months and Older
expensive, especially for the smaller vegetable varieties cannot guarantee delivery
The proposed rule adds infant food fruits
proprietors common in neighborhoods with of priority nutrients at recommended levels.
and vegetables to revised Package II in part
significant WIC-eligible populations. Of But, supported by local agency nutrition as a preferred replacement for fruit juice.
course, high concentrations of WIC-eligible education, the proposed rule is expected to This alternative questions whether the fruit
shoppers might allow smaller vendors to increase the intake of those nutrients. And to juice eliminated from the infant food
stock these foods profitably, however, that the extent that WIC participants, like packages needs to be replaced at all.
raises the second concern about whether Americans generally, consume too little from With the exception of low iron and zinc
jlentini on PROD1PC65 with PROPOSAL2
such a narrow vegetable option will increase the fruit and vegetable groups overall, WIC- intakes by the relatively small population of
consumption. provided fruits and vegetables may displace fully breastfed infants age six months and
IOM and the USDA recognize the less healthy foods from the diet, and help older, IOM identified no nutrient
difference between a food package that inadequacies among WIC infants. IOM
simply offers needed nutrients to WIC 65 IOM, p. 118. understands that WIC foods are offered to
participants, and one that encourages 66 Id. supplement the diets of program
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44850 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
beneficiaries. ‘‘Thus, food groups and offering jarred infant foods as a replacement. The overall cost of the proposed rule
nutrients that are lacking in the diet are to If this assumption about parents’ behavior would be significantly reduced if modified to
be emphasized, rather than staple foods that could be substantiated, then elimination of eliminate both juice and infant foods from
are already adequate in the diet.’’ 67 jarred infant food from the proposed rule the infant food packages. The five year cost
Accepting, for argument’s sake, that parents would reduce costs without placing infants at of the rule, as modified by this alternative,
are likely to introduce complementary foods
to their infants at six months of age, nutritional risk. Those savings could be used is $¥983.6 million. The cost of the proposed
regardless of the content of the WIC food to allow for the full IOM-recommended level rule, without modification, is $¥34.2 million
packages, it may make sense to eliminate of fruits and vegetables or the savings could (see Table 3.)
juice from the infant food packages without be redirected to other government priorities.
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 assistance to parents, and helps ensure the meet, with a restrictive whole grain bread
two of the broader goals of the WIC food health of their infants with foods that deliver and cereal requirement.
package redesign effort. The first seeks to the only two priority nutrients found lacking However, refined grains are not lacking in
encourage WIC participants to increase their in WIC’s infant population. Because this the American diet. The proposed rule’s fruit
intake of fruits and vegetables. This effort, alternative would undermine two the key and vegetable provision encourages the
backed by the recommendations of current goals of the WIC food package redesign effort, consumption of foods that are
nutrition science, and reflected in the 2005 it was rejected. underconsumed as a group. By contrast, the
Dietary Guidelines for Americans, is 4. Drop the Whole Grain Requirement for 2005 Dietary Guidelines for Americans
weakened by this alternative food package Both Bread and Cereal recommend that refined grains be replaced
proposal. The proposed rule, unlike this (not supplemented) with whole grains.70
alternative, sends a clear message that a The proposed rule requires that bread and
the bread substitutes added to the children Other arguments that might be raised
variety of semi-solid fruits and vegetables is
and women food packages meet FDA label against the whole grain requirement are
preferred to fruit juice as an early
standards for the health claim for whole grain possible limited availability of whole grain
complementary food as baby food fruits and
foods with moderate fat content. In addition, products at some WIC vendor sites, and
vegetables serve to introduce older infants to
new flavors and textures.68 the rule requires that cereal in all but the higher food package costs. Although the need
A second goal of food package redesign infant food packages meet the same whole to stock additional whole grain items will be
effort that is not met through this alternative grain standard. Relaxing the whole grain an economic burden to some WIC vendors,
proposal is the promotion of breastfeeding. requirement is an alternative that may be increased sales to WIC participants may
The proposed rule offers twice the amount of supported with arguments similar to those justify the added vendor expense.
infant food fruits and vegetables to fully behind the rule’s broad fruit and vegetable Food package costs under the proposed
breastfed infants that it offers to partially or provision. IOM’s whole grain rule will likely exceed the cost of otherwise
fully formula-fed infants. IOM and the USDA recommendation is motivated by nutrition equivalent packages that lack the whole grain
are optimistic that increasing the value of the research that recognizes low fiber intake as requirement.71 The overall cost of the
food package offered to fully breastfed infants a health risk factor.69 Nevertheless, low fiber proposed rule would be significantly reduced
will provide the type of economic support intake is a consequence of consumer choice. if modified to eliminate the whole grain
that will encourage mothers to continue Simply mandating that WIC grain products requirement. Because this alternative
breastfeeding beyond six months. The meet the FDA’s whole grain standard may provides less nutritional benefit relative to
introduction of infant food meat to the fully not increase whole grain consumption or the 2005 Dietary Guidelines for Americans
breastfed package is intended to provide the fiber intake. Product variety is more limited, recommendations and saves very little, it was
same incentive; it extends economic and cultural preferences may be difficult to 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
67 IOM, p. 81. wheat and multi-grain bread averaged $1.25 per lb price per ounce of $0.155; restricting those brands
jlentini on PROD1PC65 with PROPOSAL2
68 IOM, p. 103. in CY 2003. The comparable price for bread to ones identified by FNS as whole grain produced
69 USDHHS/USDA, 2005, p. 5. specified without the whole grain restriction was an average price of $0.152. (Given the uncertainty
70 Id., p. 25.
just $0.98. CY 2003 Homescan data suggest that low of a price difference between whole grain WIC
income households paid $1.17 per pound for brown cereals and all WIC cereals, the whole grain price,
71 To estimate the cost of the alternative, AC
rice, and just $1.05 for all varieties of rice. Selecting adjusted for inflation, was used in both the current
Nielsen Homescan data were used. Prices paid by cereal brands representative of those allowed under program cost estimate and the cost of the proposed
households with WIC-eligible incomes for whole current WIC rules produced an average CY 2003 rule.)
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44851
G. Market Analysis the foods purchased with WIC vouchers calendar year (CY) 2004 participation, cost
The proposed changes in the quantities would otherwise be purchased with the and sales estimates for our market share
and types of foods provided by the WIC participants’ own funds. In both scenarios, analysis. Although the rule does not take
the potential impact of the proposed rule on effect until FY2007, we cannot reliably make
program should result in changes in the
the total market size for most foods is projections about the overall sales of WIC
quantities and types of foods that WIC
relatively modest, as is the impact on WIC’s food items for the next three years; we
participants buy with their WIC vouchers. share of the total market.
The complete market impact of this rule is believe the CY2004 data provides a good
We estimated the total value of WIC indication of the relative impact of the rule’s
difficult to accurately quantify, because we sales 73 for each food item and the total
do not know the extent to which WIC foods changes on each food item.
annual U.S. retail sales for each WIC food
substitute for purchases WIC participants It is important to note that this approach
item. To estimate WIC sales, we multiplied
would have otherwise made with their own the average unit price per food item by an understates the size of the total markets for
funds. Empirical research on this issue is estimate of the quantity of food purchased by WIC food items (and thus overstates both
inconclusive.72 Because of this uncertainty, WIC participants (the average estimated WIC’s market share and the potential impact
we present two scenarios. In the first (Table participation multiplied by the amount of of the proposed change on WIC food
16), we assume full substitution—that is, all food prescribed to a participant throughout markets), because the data used to estimate
foods purchased with WIC vouchers under the course of a year).74 To estimate total total market size is limited to grocery store
the current packages would otherwise be annual sales, 2004 AC Nielsen Productscan sales. Data on sales through other outlets was
purchased with the participants’ own funds data was used to calculate total volume and not available, but would likely significantly
under the proposed rule. In the second (Table annual grocery store sales of the different increase the estimated size of the total market
17), we assume the alternate—that none of categories of food products.75 We used for WIC foods.
TABLE 16.—ESTIMATED TOTAL ANNUAL SALES, WIC SALES, AND WIC PERCENT OF MARKET FOR CURRENT FOOD PACK-
AGE AND PROPOSED FOOD PACKAGE, ASSUMING FULL SUBSTITUTION OF WIC FOODS IN TOTAL ANNUAL SALES,
CY2004
Current food package Proposed food package
WIC food item Estimated total Estimated total WIC WIC % of Estimated total Estimated total WIC WIC % of
annual sales sales market 77 annual sales sales market 77
($) ($) 76 ($) ($)
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
72 Mary Kay Fox, William Hamilton, Biing-Hwan cereals of any sugar content and cereals without WIC vendors such as small, non-chair, convenience
Lin, Effects of Food Assistance and Nutrition whole grains). This was done to accurately portray and ‘‘WIC-Only’’ stores.
Programs on Nutrition and Health, Volume 3, the impact of the proposed food package on the 77 ‘‘WIC % of Market’’ estimates are calculated
Literature Review, Economic Research Service, U.S. whole market and not just the narrow sub-market only for items for which we have both a numerator
Department of Agriculture, Food Assistance and of ‘‘WIC eligible’’ food. Because AC Nielsen and denominator.
Nutrition Research Report Number 19–3. October Productscan data covers approximately 70% of the 78 We were unable to assess the market impact of
2004. total grocery market, total annual sales were
73 WIC sales refer only to sales produced by the adjusted by dividing by 70%. four items in the WIC food package; tofu, soy
use of WIC vouchers, not the total sales from all 76 Total WIC sales reported here are less than the beverage, baby food, and infant cereal. These items
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purchases made by WIC participants. $5.2 billion dollars (pre-rebate) reported in WIC are not included in the Productscan data; however,
74 Prescription amounts used in this market share 2004 food costs. The estimates of total WIC food we are able to estimate WIC sales because these
analysis are the same as those used in the cost sales for the current and proposed packages are items are part of the Homescan data, which is our
analysis. likely to be lower than actual WIC food source for item price data.
79 Total ‘‘WIC % of Market’’ estimates are
75 Total annual sales include foods that fit in the expenditures because the AC Nielsen Productscan
category of food product, but may not be WIC and Homescan data used to estimate food prices calculated only for items for which we have both
eligible (i.e., within cereal, total sales include may not fully capture the higher prices charged by a numerator and denominator.
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44852 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE 17.—ESTIMATED TOTAL ANNUAL SALES, WIC SALES, AND WIC PERCENT OF MARKET FOR CURRENT FOOD PACK-
AGE AND PROPOSED FOOD PACKAGE, ASSUMING NO SUBSTITUTION OF WIC FOODS IN TOTAL ANNUAL SALES,
CY2004
Current food package Proposed food package
WIC food item Estimated pro- Estimated total WIC % of Estimated total Estimated total WIC % of
posed total annual WIC sales market 81 WIC sales WIC sales market 81
sales ($) 80 ($) ($)
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 is mostly due to a reduction in the maximum women and children participants with much
proposed estimated WIC sales differ from the allowance of infant formula for partially greater access to these foods.
costs reported in Table 3 mainly because the breastfed and fully formula-fed infants 6 For the foods being added to the WIC food
market analysis uses pre-rebate formula costs through 11 months of age (Food Package II package, the WIC market share percentages
as compared to the cost estimate which FF). are, for the most part, small, 0.9% and 3.0%–
factors in the post-rebate savings. In addition, The other markets that will be impacted 3.1%, for bread and rice, respectively. We
the data in the market impact analysis is and are currently part of the food package are were unable to assess the market impact of
based on CY2004 participation whereas the the milk, juice, eggs, bean, cheese, peanut four items in the food package: tofu, soy
cost estimate uses the projected participation butter, and fruit and vegetable markets. The beverage, baby food, and infant cereal. These
estimates for 2007 and beyond. Finally, the market share of these items will change items are not included in the Productscan
market analysis does not take into account slightly. The items that will have decreases data; however we are able to estimate WIC
any phase-in period. are milk, juice, eggs, and cheese, while the sales because these items are part of the
Overall, the changes in the WIC food items that will have increases are beans, Homescan data, which is our source for item
package will have a modest impact on WIC peanut butter, and fruits and vegetables. The price data.
sales as a percentage of total annual sales of WIC market share of milk will change from Given the changes in market share and
these food item categories. Market shares are 6% to 4.5%–4.6% due to lower prescription potential changes in total market demand,
slightly higher under the no substitution amounts and the ability of participants to changes in the purchases of WIC-provided
scenario. (See Table 17). For the foods that substitute tofu, and soy beverage for fluid foods could theoretically have an impact on
are currently part of the food package, the prices for WIC foods. However, because the
milk. The decline in cheese is also due to
proposed food package has the largest dollar demand impacts for most foods are small and
these reasons. The share of the juice market
impact on the infant formula market. Under impossible to estimate precisely, we are
shifts from 6.1% to 3.1%–3.2%, while the
the proposed food package, the market share unable to determine the potential price
share of the egg market shifts from 3.5% to
of WIC sales for infant formula is less than effects.
1.9%. Both of these declines stem from
with the current food package. The decline WIC purchases of infant formula represent
changes in the package that are designed to a larger share of the total market of WIC-
80 Total WIC sales reported here are less than the
improve the overall nutritional benefit of the provided foods than do WIC purchases of the
package. Participants will be receiving less other WIC foods. The Economic Research
$5.2 billion dollars (pre-rebate) reported in WIC
2004 food costs. The estimate of total WIC food juice, but more fruits and vegetables. The Service (ERS) recently studied the
sales for the current and proposed packages are amount of eggs will be lowered consistent relationship between retail prices of infant
likely to be lower than actual WIC food with recommendations of the IOM on formula and demand for WIC-provided
expenditures because the AC Nielsen Productscan cholesterol intake and to permit a wider formula. ERS findings suggest that the
and Homescan data used to estimate food prices variety of foods to be included in the WIC
may not fully capture the higher prices charged by
amount of WIC-provided formula purchased
food packages. The market share of beans has an effect on retail prices; specifically,
WIC vendors such as small, non-chain, convenience
and ‘‘WIC-Only’’ stores.
will increase from 1.8% to 4.5%–4.6%. The larger WIC demand leads to higher retail
81 ‘‘WIC % of Market’’ estimates are calculated majority of this impact stems from the fact prices for non-WIC consumers who purchase
only for items for which we have both a numerator that participants can now substitute canned the state’s contract brand of formula.84 ERS
and denominator. beans, which are more expensive, for dried found that the larger the relative size of the
82 We were unable to assess the market impact of beans. The market share of peanut butter will WIC program, the greater the retail price of
four items in the WIC food package: tofu, soy increase from 3.3% to 4.5%. Lastly, the WIC the contract brand of infant formula, ranging
beverage, baby food, and infant cereal. These items percent of the fruit and vegetable market will
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from 8 to 14 cents across brands of milk-
are not included in the Productscan data; however, increase from 0% to 2.0%–3.1%. This is due
we are able to estimate WIC sales because these based powder infant formula and from 3 to
items are part of the Homescan data, which is our
to the fact that the only fruit or vegetable that
source for item price data. WIC participants currently receive are carrots 84 Victor Olivera, Mark Prell, David Smallwood,
83 Total ‘‘WIC % of Market’’ estimates are and only exclusively breastfeeding mothers ˜
Elizabeth Frazao, WIC and the Retail Price of Infant
calculated only for items for which we have both receive them. Under the new rule, the fruit Formula, Economic Research Service, U.S.
a numerator and denominator. and vegetable vouchers will provide WIC’s Department of Agriculture, May 2004, p. 60.
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Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules 44853
11 cents across brands of non-contract projecting the impact of the rule on overall 49%–54%) is smaller than the changes in
powder infant formula for a one-unit change demand would require an analysis of the WIC sales examined in the ERS report (from
in relative size of WIC (e.g., WIC’s share of behavior of non-WIC consumers, which have 50% to 66%). We invite comment on the
all formula-fed infants increase from one-half more diverse purchasing habits. For instance, impact of the proposed revisions to the WIC
to two-thirds of all formula-fed infants). many non-WIC formula purchases are at packages on food prices.
However, it is difficult to project the exact prices below that of supermarkets from mass
impact of the reduction in WIC demand for merchandisers that do not participate in the Appendix: Additional Cost Estimate
infant formula under the proposed rule based WIC Program. In addition, the change in WIC Assumptions
on this study. The ERS analysis was limited formula sales as a percentage of retail grocery
to formulas sold in supermarkets, whereas sales due to this proposed rule (from 58% to
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 TABLE B.—FY 04 PRICE INFLATION TABLE B.—FY 04 PRICE INFLATION
ASSUMPTIONS USING FY 04 FOOD ASSUMPTIONS USING FY 04 FOOD ASSUMPTIONS USING FY 04 FOOD
SPECIFIC CPIS SPECIFIC CPIS—Continued SPECIFIC CPIS—Continued
Inflation rate Inflation rate Inflation rate
Food item Food item Food item
(percent) (percent) (percent)
Infant cereal .............................. ¥0.8 Soy beverage ........................... 3.0 Peanut butter ............................ 0.6
Infant food fruit and vegetables: Juice ......................................... ¥1.4 Whole grain bread .................... 0.4
Infant food meat ................ 2.6 Adult cereal: Brown rice ................................. 5.7
Bananas ............................ ¥1.0 Whole grain ....................... ¥0.8 Tuna .......................................... 0.1
Milk: Current WIC cereals .......... ¥0.8 Salmon ...................................... 0.1
Whole ................................ 11.0 Eggs .......................................... 11.3 Carrots ...................................... 1.3
Reduced fat ....................... 9.1 Beans:
Cheese ..................................... 5.2 Dry ..................................... 0.4
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Tofu ........................................... 3.0 Canned .............................. 0.4
85 Current Food Package III is $0 because the not have comprehensive data on the current cost of foods from other packages to food package III
analysis only considers the incremental costs medical foods provided in Food Package III. recipients. All other food package costs reflect the
associated with the proposal. Proposed Food However, the medical foods associated with this full package costs.
Package III represents the incremental costs as a package stay the same under the current and 86 FY 07 is multiplied by 11 months.
result of the changes in the proposed rule. FNS does proposed rules. The incremental cost is extending
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44854 Federal Register / Vol. 71, No. 151 / Monday, August 7, 2006 / Proposed Rules
TABLE C.—INFLATION ASSUMPTIONS, TABLE C.—INFLATION ASSUMPTIONS, TABLE C.—INFLATION ASSUMPTIONS,
FY 04–FY 11 FY 04–FY 11—Continued FY 04–FY 11—Continued
CPI: Fruit CPI: Fruit CPI: Fruit
Thrifty food Thrifty food Thrifty food
and vegeta- and vegeta- and vegeta-
Year plan Year plan Year plan
bles bles bles
(% change) (% change) (% change)
(% change) (% change) (% change)