Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages, 68966-69032 [E7-23033]
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DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
7 CFR Part 246
[FNS–2006–0037]
RIN 0584–AD77
Special Supplemental Nutrition
Program for Women, Infants and
Children (WIC): Revisions in the WIC
Food Packages
Food and Nutrition Service,
USDA.
ACTION: Interim rule.
AGENCY:
SUMMARY: This interim rule revises
regulations governing the WIC food
packages to align the WIC food packages
with the Dietary Guidelines for
Americans (DGA) 1 and current infant
feeding practice guidelines of the
American Academy of Pediatrics, better
promote and support the establishment
of successful long-term breastfeeding,
provide WIC participants with a wider
variety of food, and provide WIC State
agencies with greater flexibility in
prescribing food packages to
accommodate participants with cultural
food preferences.
DATES: Effective Date: This rule is
effective February 4, 2008.
Implementation Date: State agencies
must implement the provisions of this
rule no later than August 5, 2009.
Comment Date: To be considered,
comments on this interim rule must be
postmarked on or before February 1,
2010.
The Food and Nutrition
Service (FNS) invites interested persons
to submit comments on this interim
rule. Comments may be submitted by
any of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov, select
‘‘Food and Nutrition Service,’’ from the
agency drop-down menu, then click
‘‘Submit.’’ In the Docket ID column,
select FNS–2006–0037 to submit or
view public comments and to view
supporting and related materials
available electronically. Information on
using Regulations.gov, including
instructions for accessing documents,
submitting comments, and viewing the
docket after the close of the comment
period, is available through the site’s
‘‘User Tips’’ link.
• Mail: Send comments to Patricia N.
Daniels, Director, Supplemental Food
Programs Division, Food and Nutrition
Service, USDA, 3101 Park Center Drive,
Room 528, Alexandria, Virginia 22302,
(703) 305–2746.
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ADDRESSES:
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Comments submitted in response to
this interim rule will be included in the
record and will be made available to the
public. Please be advised that the
substance of the comments and the
identities of the individuals or entities
submitting the comments will be subject
to public disclosure. FNS will make the
comments publicly available on the
Internet via https://www.regulations.gov.
Information regarding the interim rule
will be available on the FNS Web site
at https://www.fns.usda.gov/wic. A
regulatory impact analysis has been
prepared for this rule. It follows this
regulation as an Appendix.
FOR FURTHER INFORMATION CONTACT:
Debra Whitford, Chief, Policy and
Program Development Branch,
Supplemental Food Programs Division,
Supplemental Food Programs Division,
Food and Nutrition Service, USDA,
3101 Park Center Drive, Room 528,
Alexandria, Virginia 22302, (703) 305–
2746, or Debbie.Whitford@fns.usda.gov.
SUPPLEMENTARY INFORMATION:
I. Overview
This interim rule implements the first
comprehensive revisions to the WIC
food packages since 1980. These revised
food packages were developed to better
reflect current nutrition science and
dietary recommendations than do
current food packages, within the
parameters of current program costs.
II. Background
The WIC food packages provide
supplemental foods designed to address
the nutritional needs of low-income
pregnant, breastfeeding, nonbreastfeeding postpartum women,
infants and children up to five years of
age who are at nutritional risk. WIC food
packages and nutrition education are
the chief means by which WIC affects
the dietary quality and habits of
participants. WIC is a unique nutrition
assistance program in that it also serves
as an adjunct to good health care during
critical times of growth and
development to prevent the occurrence
of health problems and to improve the
health status of Program participants.
WIC was never intended to be a primary
source of food, nor of general food
assistance. Rather, WIC food benefits are
scientifically-based and intended to
address the supplemental nutritional
needs of a specific population—low
income pregnant, breastfeeding, nonbreastfeeding postpartum women,
infants and children up to five years of
age who are at nutritional risk. In
addition to WIC, the Food and Nutrition
Service (FNS) administers a variety of
other complementary nutrition
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assistance programs that work together
to provide a more complete diet to lowincome persons. Low-income families
can, and frequently do, receive benefits
from more than one of these programs.
The largest of these programs, the Food
Stamp Program, provides general food
assistance intended to increase the food
buying power of low-income
households.
The ability of the WIC food packages
to reinforce nutrition education
messages provided to participants is
critical to affecting the dietary quality
and habits of infants, children and
mothers served by WIC. The nutrition
education provided by WIC enables
participants to make informed decisions
in choosing foods that, together with the
supplemental foods contained in the
WIC food packages, can meet their total
dietary needs. The intent is to help
participants continue healthful dietary
practices after leaving the Program.
Since the creation of the WIC Program
in the 1970s, and the last major revision
of the WIC food packages in the early
1980’s, much has been learned about the
nutritional needs of Americans,
including WIC’s target population of
pregnant and postpartum women,
infants, and preschool aged children. In
recent years the ability of the WIC
Program to address the supplemental
nutritional needs of WIC participants
through its food packages and nutrition
education has received growing
attention. Significant interest in
updating the food packages based on
new information about the needs of lowincome, culturally diverse women,
infants, and children has been voiced by
WIC Program administrators, the
medical and scientific communities,
advocacy groups, and Congress.
III. General Summary of Comments
Received on the Proposed Rule To
Revise the WIC Food Packages
The Proposed Rule to revise
regulations pertaining to the
supplemental foods provided through
the WIC Program was published in the
Federal Register on August 7, 2006 (71
FR 44784), with a 90-day comment
period. The proposed rule largely
reflected recommendations made by the
National Academies’ Institute of
Medicine (IOM) in its Report ‘‘WIC
Food Packages—Time for a Change,’’ (2)
with modifications found necessary by
FNS to ensure cost neutrality.
A total of 46,502 comment letters
were received on the Proposed Rule; of
those, 23,908 were form letters. A total
of 38,257 letters were received from
program participants; 18,080 of those
were form letters. The remaining
comment letters were submitted from a
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variety of sources, including WIC State
and local agencies and Indian Tribal
Organizations, the National WIC
Association (NWA), professional
organizations and associations,
advocacy groups, healthcare
professionals (including universities),
members of Congress, the food industry,
vendors, farmers, and private citizens.
In general, the proposed changes to
the WIC food packages garnered broad
support from public commenters. A
total of 21,042 commenters (8,293 of
these form letters) made explicit
statements regarding the merits of the
proposed rule as a whole. Of those,
20,438 (8,292 of which were form
letters) expressed support for the
majority of the proposed revisions. A
total of 604 commenters (1 of these a
form letter) disagreed with the majority
of the proposed rule provisions—these
letters were primarily from participants
who did not want to see any changes to
the current WIC food packages. FNS
considered all comments without regard
to whether they were provided by a
single commenter or repeated by many.
Importance was given to the substance
or content of the comment, rather than
the number of times a comment was
submitted.
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IV. Discussion of the Proposed
Provisions
The following is a discussion of the
major provisions set forth in the
proposed rule, a brief summary of the
comments received that addressed these
issues, and FNS’ rationale for either
modifying each section in the interim
rule, or retaining its provisions as
initially proposed. Provisions not
addressed in the preamble to this
interim rule did not receive significant
or substantial public comments and are
retained in this interim rule as
proposed.
This preamble articulates the basis
and purpose behind significant changes
from the August 7, 2006, proposal. The
reasons supporting provisions of the
proposed regulations were carefully
examined in light of the comments to
determine the continued applicability of
the justifications. Unless otherwise
stated, or unless inconsistent with the
interim rule or this preamble, the
rationales contained in the preamble to
the proposed regulations should be
regarded as a basis for the interim rule.
Therefore, a thorough understanding of
the rationales for the interim regulations
may require reference to the preamble of
the August 7, 2006 proposal (71 FR
44784).
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A. Definitions
1. Participation. FNS proposed to
revise the definition for WIC
‘‘participation’’ to include the number
of breastfeeding women who receive no
supplemental foods or food instruments
but whose breastfed infant(s) receives
the supplemental foods or food
instruments. The definition means,
therefore, that a partially breastfeeding
woman who requests, after the sixth
month postpartum, more than the
maximum amount of formula allowed
for a partially breastfed infant would no
longer receive a food package but would
continue to count as a WIC participant
and receive other Program benefits and
nutrition services (nutrition education,
including breastfeeding promotion and
support, and referrals to health and
social services.) Thirty-two commenters
(15 form letters) were opposed to not
providing a food package to partially
breastfeeding women who request, after
the sixth month postpartum, more
formula than the maximum.
The IOM recommended that a
partially breastfeeding woman who
requests, after the sixth month
postpartum, more than the maximum
amount of formula for a partially
breastfed infant, no longer be certified
for the WIC Program. However, FNS
determined that this approach is
incongruous with the definition of
breastfeeding in WIC regulations at 7
CFR 246.2—the practice of feeding a
mother’s breastmilk to her infant(s) on
the average of at least once per day. In
WIC, this definition is used to
determine Program eligibility, and
allows all breastfeeding women,
regardless of feeding pattern, to
participate in the WIC Program, be
counted as a breastfeeding woman, and
receive supplemental foods,
breastfeeding promotion and support,
and referrals to health care. The
definition recognizes that any
breastfeeding, even if only on an average
of once a day, provides some
immunological and nutritional benefits
that would otherwise not be provided to
an infant. Rather than adopt IOM’s
recommendation in its entirety, FNS
proposed to revise the definition for
WIC ‘‘participation’’ to include
breastfeeding women who receive no
supplemental foods or food instruments
but whose breastfed infant(s) receives
supplemental food or food instruments.
Counting these women, although they
are not receiving a food package, is
consistent with the current practice of
counting the infants of exclusively
breastfeeding women. Therefore, a
partially breastfeeding woman who
requests, after the sixth month
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postpartum, more than the maximum
amount of formula allowed for a
partially breastfed infant would no
longer receive a food package but would
continue to count as a WIC participant
and receive other Program benefits
(nutrition education, including
breastfeeding promotion and support,
and referrals to health and social
services). This would serve to meet the
intent of IOM’s recommendations
within the context of WIC regulations.
As recommended by some
commenters, FNS clarifies that
breastfeeding women who receive no
supplemental foods or food instruments
but whose breastfed infant(s) receives
the supplemental foods or food
instruments continue to be eligible to
receive nutrition services, and breast
pumps are a part of nutrition services.
With this clarification, the definition of
participation is retained in this interim
rule as proposed at 7 CFR 246.2.
2. WIC-eligible medical foods. FNS
proposed to revise the definition for
‘‘WIC-eligible medical foods’’ to clarify
that medical foods are designed for
children 12 months and older and
adults and that WIC-eligible medical
foods are not conventional foods, drugs,
flavorings or enzymes. A few
commenters disagreed with the
proposed definition for WIC-eligible
medical foods stating that the definition
as proposed would exclude infants from
receiving certain medical foods that are
appropriate for them such as modular
formulas that are not nutritionally
complete but add specific nutrients
such as protein, fat, and carbohydrate.
FNS acknowledges that certain medical
foods exist that are appropriate for use
by infants and that medically fragile
infants should be included as a
participant category in the WIC-eligible
medical food definition. Several other
commenters believe that FNS should
rely on Food and Drug Administration
(FDA) expertise for the definition of
medical foods since FDA is the
regulatory authority for medical foods.
FNS acknowledges FDA’s role in the
regulation of medical foods. However,
specific requirements for the safety or
appropriate use of medical foods have
not yet been established by FDA.
FNS agrees with commenter concerns
that the proposed definition for WICeligible medical foods excludes infants
as a participant category. Therefore, the
proposed definition for WIC-eligible
medical foods is revised in this interim
rule to include infants as a participant
category.
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B. General Provisions That Affect All
WIC Food Packages
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1. Food Lists
The proposed rule would have
continued to require State agencies to
identify brands and package sizes that
are acceptable for use in their States
from among those authorized and to
provide to local agencies a list of
acceptable foods and their maximum
monthly allowances in accordance with
WIC requirements. This provision is
retained in this interim rule at 7 CFR
246.10(b)(2)(i). A conforming
amendment in this interim rule at 7 CFR
246.4 clarifies that a copy of the food
list must be included in the State Plan.
2. Nutrition Tailoring
Current FNS policy allows both
categorical and individual nutrition
tailoring of WIC food packages.
Categorical nutrition tailoring is the
process of modifying the WIC food
packages for participant groups or
subgroups with similar supplemental
nutrition needs, based on scientific
nutrition rationale and State established
policies. The proposed rule would have
prohibited categorical nutrition
tailoring, but continue to allow
individual nutrition tailoring based on
the Competent Professional Authority’s
assessment of a participant’s
supplemental nutrition needs.
A total of 528 commenters (of these,
505 were form letters) agreed with the
proposal to eliminate State authority to
categorically tailor food packages,
stating that the careful balance achieved
by the IOM’s recommendations to revise
the WIC food packages should be
maintained. In contrast, 187
commenters (of these, 151 were form
letters) were opposed to the provision,
stating that States need the flexibility to
propose modifications to food packages
that respond to rapid changes in food
industry, science, demographics, and
other factors.
As discussed at length in the
preamble to the proposed rule, the
revised food packages have the potential
to address current nutrient inadequacies
and excesses; discrepancies between
dietary intake and dietary guidance; and
current and future health-related
problems in WIC’s target population.
The IOM was also charged with
considering the cultural needs of WIC
participants and its recommendations
for revisions to the WIC food packages,
and the proposed rule, reflect those
considerations. The IOM had the
resources and capacity to conduct an
independent, rigorous scientific review
of the nutritional needs of WIC
participants in each category prior to
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recommending the quantities and types
of WIC foods to address those needs in
its Report.(2) Because the IOM based the
revisions to the WIC food packages on
current nutrition science, FNS proposed
that State agencies would no longer be
authorized to categorically tailor food
packages.
FNS believes that State agencies will
best be able to meet the nutritional
needs of each WIC participant through
nutrition assessment and individual
tailoring of the food package. Therefore,
the provision to disallow State agency
proposals to categorically tailor WIC
food packages is retained in this interim
rule at 7 CFR 246.10(c). FNS clarifies
that, in addition to having the authority
to individually tailor food packages,
State agencies continue to have the
authority to make adjustments to WIC
foods for administrative convenience
and to control costs. Such adjustments
may involve packaging methods,
container sizes, brands, types and
physical forms of WIC foods.
3. Cultural Food Package Proposals
A total of 174 commenters (of these,
149 were form letters) were opposed to
FNS’ proposal to no longer consider
WIC State agency requests for cultural
food substitutions. Commenters cited
the need for State agencies to have the
flexibility to keep pace with
demographic changes in the WIC
population.
FNS believes that the increased
variety and choice in the supplemental
foods in this interim rule provide State
agencies expanded flexibility in
prescribing culturally appropriate
packages for diverse groups. Section
203(c) of Public Law 108–265 amended
Section 17(c)(2) of the Child Nutrition
Act of 1966, as amended (42 U.S.C.
1786), by requiring the Secretary to
conduct, as often as necessary, a
scientific review of supplemental foods
available under the program and to
amend the foods, as needed, to reflect
nutrition science, public health
concerns, and cultural eating patterns.
As such, future reviews of the WIC food
packages by FNS will be used to
determine the need for additional
cultural accommodations. However, in
response to requests by commenters to
allow State agencies the flexibility to
meet unanticipated cultural needs of
participants, a new 7 CFR 246.10(i) has
been added to this interim rule that
allows State agencies to submit to FNS
a plan for substitution of food(s) to
allow for different cultural eating
patterns. The criteria for submitting
plans for substitutions for different
cultural eating patterns and the criteria
FNS will use to evaluate such plans are
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the same as those under current WIC
regulations at 7 CFR 246.10(e).
4. Medical Documentation and
Supervision Requirements
Under the proposed rule, medical
documentation would have been
required for certain milk alternatives for
children and women and for any
supplemental foods authorized in
proposed Food Package III. Under the
proposed rule, medical documentation
would continue to be required for any
contract brand infant formula that does
not meet the requirements of an infant
formula as specified in Table 4 of 7 CFR
246.10(e)(12) of the proposed rule, any
non-contract brand infant formula, any
exempt infant formula, or any WICeligible medical food.
Under current WIC regulations, the
technical requirements for medical
documentation include:
• Brand name of the WIC formula
prescribed;
• Medical diagnosis warranting the
WIC formula;
• Length of time the prescribed WIC
formula is medically required by the
participant; and
• Signature (or name, if the initial
documentation was received by
telephone) of the requesting health care
provider.
Under the proposed rule, additional
technical requirements would have been
added as follows:
• Contact information for the
participant’s healthcare provider
making the medical determination;
• Date of medical determination;
• Name of specific supplemental
food(s) to be prescribed;
• Amount prescribed per day of WIC
formula and/or supplemental foods;
• Qualifying condition that warrants
the issuance of the specific
supplemental food(s); and
• Length of time the specific
supplemental food(s) is medically
required.
A total of 2,107 comment letters
(1,945 of these were form letters)
opposed the proposed medical
documentation, primarily the
documentation for children to receive
soy-based beverage. Commenter’s stated
that the medical documentation
requirement for soy-based beverage for
children would create barriers to
services and undermine FNS’ efforts to
provide foods that meet the cultural
needs of participants. A small number
of comments received from WIC staff
primarily at the local level expressed
concern that requiring medical
documentation for the additional
supplemental foods allowed in
proposed Food Package III and requiring
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a prescribed amount per day is
burdensome to participants, the medical
community and WIC agencies.
FNS understands the potential
administrative impact of requiring
medical documentation for the
provision of supplemental foods in
Food Package III. However, these
medical documentation requirements
were proposed to ensure that the
participant’s healthcare provider,
licensed in the State to write
prescriptions, has determined that the
supplemental foods are not medically
contraindicated by the participant’s
qualifying condition. Participants that
receive Food Package III are medically
fragile and should be under the care of
a healthcare professional for the
purpose of close medical supervision
essential for the participant’s overall
dietary management. Participants that
receive Food Package III have qualifying
medical conditions that preclude or
restrict their use of conventional foods.
Requiring medical documentation to
include the additional supplemental
foods allowed in proposed Food
Package III and requiring an amount
prescribed per day will ensure that the
participant’s health care provider is
aware that WIC is providing
supplemental foods that the health care
provider has determined are not
medically contraindicated by the
participant’s qualifying medical
condition. Requiring the health care
provider to designate an amount of WIC
formula and the WIC supplemental
foods allowed in the participant’s diet
will help the Certified Professional
Authority (CPA) in designing nutrition
education and a food package
prescription that is appropriate to the
participant’s medical needs.
FNS acknowledges that some
additional administrative tasks will
occur because of medical
documentation requirements for dairy
alternatives. However, requiring
medical documentation for soy-based
beverage for children ensures that a
child’s health care provider is aware
that the child may be at nutritional risk
when milk is replaced by other foods.
The DGA (1) stress the importance of
milk consumption in the development
of bone mass for children. The IOM
noted that while soy products may be an
appropriate choice for children who
cannot consume milk, soy should not be
made available to satisfy participant
preference in the absence of medical
need. Therefore, the proposed
provisions for medical documentation
for certain milk alternatives for children
and women and for any supplemental
foods authorized in proposed Food
Package III are retained in this interim
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rule at 7 CFR 246.10(d). Proposed
provisions related to revised medical
documentation requirements that are
not addressed in this preamble did not
receive significant or substantial public
comments and are retained in this
interim rule as proposed.
5. Organic Foods
A number of commenters asked FNS
to allow organic products within the
authorized categories of foods in the
WIC food packages. FNS points out that
some organic forms of WIC-eligible
foods meet the nutritional requirements
set forth in current WIC regulations and
are therefore authorized; this interim
rule continues to authorize organic
forms of foods that meet minimum
nutrition requirements described in
Table 4 of 7 CFR 246.10(e)(12).
However, WIC State agencies are
responsible for determining the brands
and types of foods to authorize on their
State WIC food lists. Some State
agencies may allow organic foods on
their foods lists, but this will vary by
State. The decision may be influenced
by a number of factors such as cost,
product distribution within a State, and
WIC participant acceptance.
C. Supplemental Foods and Food
Packages
Note: In the interest of clarity, specific food
package issues are discussed according to
food item rather than food package and then
the food package categories are discussed.
The order of some of the topics in this
section is modified from the proposed rule
for the purposes of discussion.
1. Fruits and Vegetables in Food
Packages III Through VII
The addition of fruits and vegetables
to the WIC food packages was the most
welcomed provision of the proposed
rule across all commenter categories. Of
the total of 40,026 comment letters that
addressed fruits and vegetables, 39,961
(22,935 of these form letters) were
favorable. The majority of the few
opposing comments were from
participants who did not want to see
any changes to the current WIC food
packages.
a. Maximum Monthly Allowances
The IOM recommended that fruits
and vegetables be provided at levels of
$10 per month for women and $8 per
month for children. To achieve cost
neutrality, the proposed rule would
have established the value of fruit and
vegetable vouchers at levels of $8 per
month for women and $6 per month for
children. A total of 3,166 commenters
(2,940 of these form letters) asked FNS
to increase the cash-value vouchers to
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the level recommended by the IOM so
that participants could receive one
additional serving of fruits and
vegetables per day. Commenters cited
(1) the important benefits of fruits and
vegetables in decreasing high blood
pressure, heart disease, obesity, and
cancer; (2) the generally low
consumption of fruits and vegetables
among WIC participants; and (3) the role
that WIC can play in helping
participants meet the DGA(1) for fruit
and vegetable intake. Commenters urged
FNS to seek additional funds to provide
the cash-value vouchers at the level
recommended by IOM.
A total of 692 commenters (562 of
these form letters) asked FNS to
consider, at a minimum, increasing the
cash-value fruit and vegetable voucher
to $10 for fully breastfeeding women to
further enhance the attractiveness of
this package and provide an additional
incentive for women to breastfeed.
While FNS is in full agreement with
the IOM and commenters regarding the
benefits of fruits and vegetables for WIC
participants, it is important that
revisions to the WIC food packages be
cost neutral to protect the program’s
ability to serve the greatest number of
eligible women, infants, and children.
For fruits and vegetables, the IOM’s
intent was to move WIC participants
towards some amount of increased fruit
and vegetable consumption and, at the
same time, reinforce the role of the WIC
food packages in nutrition education.
The proposed $8 and $6 cash-value fruit
and vegetable voucher fulfilled this
intent while ensuring cost neutrality.
Therefore, the provision will be retained
in this interim rule as proposed for
children and women in Food Packages
III–VI in Table 2 of 7 CFR 246.10(e)(10)
and Table 3 of 7 CFR 246.10(e)(11).
However, FNS has considered the
benefits of increasing the value of the
vouchers for fully breastfeeding women
and has determined that a $2 increase
can be accomplished while maintaining
cost neutrality. This provision is
therefore revised in the interim rule in
Table 2 of 7 CFR 246.10(e)(10) and
Table 3 of 7 CFR 246.10(e)(11) to reflect
a cash-value voucher of $10 for fully
breastfeeding women in Food Packages
III and VII.
Thirty commenters (23 of which were
form letters) preferred that a set amount
of fruits and vegetables be authorized
per month, e.g., 3 pounds for a child, in
lieu of a cash-value voucher, for
administrative ease and to control costs.
FNS disagrees with this approach. A
voucher, rather than a more narrowly
defined fruit and vegetable option,
offers flexibility, ensures participant
access, and minimizes costs of
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compliance by administrative agencies
and WIC-approved vendors. Allowing
participants to choose a wide variety of
fruits or vegetables is intended to
increase consumption by
accommodating individual and
culturally-based preferences.
(1) State agency responsibility to
make available to participants at least
two fruits and two vegetables from the
category of fruits and vegetables in each
authorized food package. FNS proposed
that State agencies be required to make
available at least two fruits and two
vegetables to participants in Food
Packages III–VII. A total of 487
commenters (of which 418 were form
letters) opposed the provision, believing
that it undermines the IOM’s
recommendation to allow participants a
wide variety of choices within the
authorized fruit and vegetable options
by authorizing State agencies to limit
the number and variety of fruits and
vegetables.
FNS’ intention with this proposed
provision was to ensure participant
choice among the fruit and vegetables
authorized by the State agency by
expanding current WIC regulations that
require State agencies to make available
at least one food from each group in
each food package. As described in the
preamble to the proposed rule, it was
FNS’ expectation that more than two
varieties each of fruits and vegetables
would be authorized by State agencies.
Therefore, the proposed provision is
clarified in the interim rule at 7 CFR
246.10(b)(2)(ii)(B) to ensure its original
intent to require State agencies to allow
participants to use their cash value
vouchers to purchase any WIC-eligible
fruits and vegetables from among those
authorized in Table 4 of 7 CFR
246.10(e)(12). This allows participants a
wide variety of choices within the
authorized fruit and vegetable options
without restriction, in keeping with
IOM recommendations. Further, the
proposed provision at 7 CFR
246.10(b)(1)(i) is revised in this interim
rule to disallow further restrictions on
eligible fruits and vegetables.
(2) Minimum vendor stocking
requirement. Similarly, at 7 CFR
246.12(g)(3)(i), FNS proposed that WIC
authorized vendors carry a minimum of
two varieties of fruits and vegetables to
ensure participant choice at the retail
level, while acknowledging that certain
smaller vendors may not be able to stock
as wide a variety of fruits and vegetables
as larger vendors. A total of 472
commenters (418 form letters) disagreed
with this provision, stating that setting
a minimum vendor stocking
requirement of two fruits and vegetables
undermines the IOM recommendation
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to allow participants a wide variety of
choices. Of these commenters, 269 (221
form letters) stated that State agencies
should be allowed to specify minimum
stocking requirements.
FNS points out that the proposed
provision authorizes State agencies to
establish different minimums for
different vendor peer groups, thus
allowing State agencies the flexibility to
work with vendors to provide the
maximum number and variety of fruits
and vegetables that are locally
accessible, culturally appropriate and
affordable. However, it is required that
all authorized vendors must stock at
least two varieties of fruits, two varieties
of vegetables, and one whole grain
cereal authorized by the State agency.
Therefore, the provision at 7 CFR
246.12(g)(3)(i) is retained in the interim
rule as proposed; however, a technical
oversight in the proposed rule has been
corrected by clarifying that authorized
vendors must stock at least two different
varieties of fruits and two different
varieties of vegetables.
b. Inflation Adjustment
FNS proposed an option to increase
the value of the cash-value fruit and
vegetable vouchers by a whole dollar
increment. A total of 124 commenters
(75 of which were form letters) asked
that FNS commit to a yearly inflation
adjustment. FNS agrees with commenter
that it is important to maintain the value
of the vouchers over time. Cash-value
vouchers will be set at $6 for children
and $8 for pregnant and partially
breastfeeding and $10 for fully
breastfeeding women in the year in
which the food package revisions take
effect. This interim rule adds a
provision at 7 CFR 246.16(j) to adjust
the maximum value of the vouchers in
whole dollar increments using the
Bureau of Labor Statistics’ Consumer
Price Index for Fresh Fruits and
Vegetables.
c. Minimal Restrictions on Authorized
Fresh Fruits and Vegetables
To improve the consumption of fresh
fruits and vegetables and to appeal to
participants of different cultural
backgrounds, the proposed rule would
have authorized a wide variety of
choices within the authorized fruit and
vegetable options. To ensure nutritional
integrity and cost neutrality, some
minimal restrictions were proposed,
e.g., no herbs or spices, edible blossoms
of flowers, fruit leathers and fruit rollups. The majority of commenters
favored the provision to authorize a
wide variety of fruits and vegetables;
however, 9 commenters (1 of which was
a form letter) stated the opinion that the
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fruit and vegetable selections should be
limited to sources of priority nutrients.
As stated in the Regulatory Impact
Analysis that was published in the
Federal Register as an appendix to the
proposed rule, FNS considered
alternatives to the proposed provision,
including authorizing a more restrictive
dark green and orange vegetable
provision. This alternative was rejected
because FNS believes that WIC food
packages that reflect the IOM
recommendations as closely as possible
within the constraints of cost neutrality
best reflect current scientific consensus
on how to meet the supplemental
dietary needs of WIC participants. The
IOM chose not to emphasize the dark
green and orange vegetable groups that
tend to offer the highest concentrations
of certain priority nutrients and instead
recommended a fruit and vegetable
option with few restrictions. Nutrition
education offered by local WIC agencies
will remain the primary method of
encouraging participants to incorporate
these high nutrient fruits and vegetables
into their diets; under this interim rule
participants remain largely free to
choose the fruits and vegetables that
they find most appealing.
Thirteen commenters (2 of which
were form letters) believe that FNS
should simplify the proposed minimal
restrictions to ease interpretation and
implementation for participants,
vendors, and staff. A total of 128
commenters (125 of which were form
letters) asked FNS to allow State
agencies flexibility to promote produce
selections that come in standard
packages with Universal Product Codes
to minimize burden. As stated above,
the nutrition education provided to
participants is intended not only to
encourage participant choice in the
selection of fruits and vegetables, but
also to provide information on shopping
tips to obtain the maximum value of the
voucher.
FNS is aware that State agencies will
need to provide training and technical
assistance to participants and vendors
in implementing the food package
changes. State agencies generally update
their food lists on a biennial basis which
requires training for both participants
and vendors. Recognizing the extensive
changes that will be necessary as a
result of this rule, FNS will assist State
agencies on vendor training, participant
education, and other implementation
issues. FNS also encourages State
agencies to work with their vendor
associations as they develop their new
State procedures, particularly in regard
to the cash-value fruit/vegetable
voucher.
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d. Disallowance of White Potatoes
Under the proposed rule, white
potatoes would have been excluded
from authorization in the WIC food
packages. A total of 324 commenters (of
these 291 were form letters) opposed the
restriction of white potatoes. Twentyfour commenters stated that white
potatoes should be included in the WIC
food packages because they are
versatile, economical and contain key
nutrients. Thirteen commenters (1 form
letter) from WIC State and local agencies
stated that the exclusion of white
potatoes would be hard to administer.
The restriction of white potatoes, as
recommended by the IOM, is based on
the amounts suggested in the DGA(1) for
consumption of starchy vegetables; food
intake data indicating that consumption
of starchy vegetables meets or exceeds
these suggested amounts; and food
intake data showing that white potatoes
are the most widely used vegetable.
Therefore, this provision is retained in
the interim rule as proposed in Table 4
of 7 CFR 246.10(e)(12).
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e. Implementation of Fruit and
Vegetable Options
(1) Small dollar denomination of fruit
and vegetable food instruments. In the
preamble to the proposed rule, FNS
encouraged State agencies to issue small
denomination, i.e., $2, cash-value fruit
and vegetable food instruments. The
small denominations were encouraged
so the participant could obtain small
amounts of fresh produce at various
times during the month, lessening the
chance of food spoilage and waste. A
total of 200 commenters (of which 133
were form letters) disagreed with FNS’
recommendation to provide the fruit
and vegetable value in small
denominations. The majority of those in
opposition were WIC State and local
agencies who stated that they should be
allowed to determine, in partnership
with vendors, the most cost effective
method to provide the fruit and
vegetable food instrument. FNS clarifies
that although State agencies are
encouraged to provide the cash-value
food instrument in small denominations
for the reasons cited above and in the
proposed rule, State agencies will
determine the dollar denomination that
is most beneficial to participants and
cost effective given the State agency’s
infrastructure and environment.
(2) Paying cash with the fruit/
vegetable voucher. Nineteen
commenters asked that participants be
allowed to pay the difference when the
purchase exceeds the value of the fruit/
vegetable voucher. Under current rules
at 7 CFR 246.12(c), State agencies must
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ensure that participants receive their
authorized supplemental foods free of
charge. Such a restriction is necessary
with the ‘‘traditional’’ WIC food
instrument which reflects a specific
quantity of foods that a participant must
receive. In contrast, the fruit/vegetable
cash-value voucher reflects a maximum
dollar allotment for the participant.
Because it may be difficult to accurately
estimate the exact purchase price of the
fruit and vegetable selections,
particularly when fresh and canned or
frozen items are combined in one
purchase, FNS concurs with
commenters that participants should be
allowed to pay the difference when the
purchase of allowable fruits and
vegetables exceeds the value of the fruit/
vegetable voucher. This option would
promote increased consumption of
fruits and vegetables because
participants would be more likely to
utilize the full cash value, rather than
partially redeem the voucher for fear of
exceeding its cash value. The rule
prohibits giving cash or credit to the
participant for any unused portion of
the fruit/vegetable voucher.
(3) Benefit delivery. While most of the
food package changes will be
administered via existing State benefit
delivery systems, the cash-value fruit/
vegetable voucher will require changes
to WIC benefit delivery systems to
accommodate a more open-ended
benefit determined by a cash value
rather than a fixed quantity of a specific
food item. State agencies and vendors
must modify operations and procedures
to issue, transact, and process the
redemption of a cash value benefit. As
described in the proposed rule, options
for benefit delivery include Electronic
Benefit Transfer (EBT) and farmers’
markets.
(4) Farmers’ markets. A total of 936
commenters (of which 170 were form
letters) agreed with the provision to
allow the fruit/vegetable cash-value
voucher to be redeemed by farmers at
farmers’ markets. Eleven commenters
disagreed with the provision. Many
commenters suggested that FNS ‘‘Do no
harm to the WIC Farmers’ Market
Nutrition Program (FMNP),’’ and that
funding for the FMNP not be reduced or
procedures established that would
adversely affect its operation or
effectiveness.
FNS would like to clarify that the
regulatory requirements for the FMNP
are unchanged by this interim rule.
Many commenters incorrectly believed
that the proposal would have allowed
FMNP coupons to be redeemed at
authorized WIC vendors. This is not
true; the proposal would have allowed
the WIC fruit/vegetable cash-value
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voucher to be redeemed at farmers’
markets.
Of the commenters supporting the
provision to allow farmers at farmers’
markets to accept the fruit/vegetable
cash-value voucher, clarification was
requested on several issues—would
State agencies be required to authorize
farmers at farmers’ markets if they do
not currently administer the FMNP; can
farmers at farmers’ markets be treated as
seasonal vendors and only be allowed to
accept the fruit/vegetable voucher; can
the State agency enter into one contract
with the farmer that includes
requirements for both WIC and the
FMNP; and, can farmers’ markets be
excluded from the WIC vendor
monitoring and audit requirements?
In response to commenter questions,
this interim rule will not require State
agencies to authorize farmers to accept
the WIC fruit/vegetable voucher. If a
State agency chooses to authorize
farmers at farmers’ markets, it may
modify its standard vendor agreement to
address the unique circumstances of
farmers’ markets, as allowed by 7 CFR
246.12(h)(2). For example, the farmer’s
market agreement may only allow the
farmer to accept the fruit/vegetable
cash-value voucher. In addition, the
State agency can choose to enter into
one agreement with the farmer that
includes the requirements for both the
WIC and WIC Farmers’ Market Nutrition
Programs. Further, farmers would be
excluded from the vendor cost
containment requirements. The farmers
may also be excluded from the WIC
monitoring requirements provided that
they are included in the sample of
farmers upon which the FMNP
monitoring requirement is drawn. A
new 7 CFR 246.12(v) has been added
that specifies the requirements
regarding the authorization of farmers at
farmers’ markets. The rule also adds
definitions for cash-value voucher and
farmer (the same as that used in the
FMNP), and modifies the food
instrument requirements to identify the
provisions that do not apply to the cashvalue voucher. As a result of the
addition of the definitions of farmer and
cash-value voucher, we have made
conforming amendments to the
definitions of ‘‘compliance buy,’’
‘‘employee fraud and abuse,’’
‘‘participants,’’ ‘‘participant violations,’’
‘‘proxy,’’ and ‘‘nutrition services and
administration’’ to include these new
terms as appropriate.
(5) Electronic Benefit Transfer (EBT).
While the majority of State WIC
agencies deliver benefits via paper
checks or vouchers, 5 States are testing
the feasibility of EBT and an additional
State has adopted EBT statewide.
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Although it will take a number of years
to implement WIC EBT fully in all
States, the fruit and vegetable benefit
may provide opportunities for
alternative forms of benefit delivery and
allow some States to move toward
limited electronic benefit processing
prior to the implementation of EBT for
all WIC purchases. In an effort to
explore the range of possibilities for
using existing commercial infrastructure
to administer the fruit and vegetable
benefit including WIC EBT smartcard
and online solutions, commercial debit
cards, and other technologies, FNS
commissioned a study by the State
Information Technology Consortium
(SITC). Although the report is not yet
final, preliminary findings indicate that
for redemption of the fruit/vegetable
benefit, paper fruit and vegetable cashvalue checks or vouchers appear to be
the least costly and easiest to implement
by State agencies and food vendors
within a 12-month time period. The
accountability for purchasing
authorized fruits and vegetables remains
the same as other food instruments—
subject to training store clerks regarding
eligible food items and State compliance
monitoring.
Debit type cards (EBT or credit/debit)
with a magnetic strip offer potentially
cost-effective solutions that leverage the
widely available card payment
infrastructure in the United States.
Magnetic strip cards in volume can be
purchased for less than 25 cents each.
There are, for instance, many large and
smaller food vendors that already accept
credit card payments or accept EBT
cards using a four digit Personal
Identification Number (PIN). These
vendors include most authorized WIC
vendors. Focus groups with participants
were favorable to this type of alternative
because of lessened stigma while
shopping and the ability to purchase
foods incrementally rather than
forfeiting some items with a paper
instrument. Technical standards would
need to be modified to enable card use
only within authorized WIC vendor
locations and there may be a need to
define standards to facilitate retailer
and/or EBT contractor changes to
existing store equipment and software.
The accountability for purchasing
eligible foods only is similar to paper
food instruments.
WIC EBT solutions, on-line using
magnetic-strip cards or off-line using
smart cards, offer the greatest potential
to ensure that only eligible fruits and
vegetables are purchased with WIC
cash-value vouchers, but it would be
more costly for all stakeholders. These
solutions would match each item
scanned to a State list of authorized
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UPC’s and/or Price Look-Up codes or
PLUs. These solutions require
additional investment by State agencies
in cards, equipment, and maintenance
of a much larger number of product
Universal Product Codes and Price
Look-Up (PLUs) codes for fresh
produce. The fresh produce industry
has taken steps to institute greater
standardization of PLUs; however, the
seasonal and local produce suppliers do
not always have means to use PLUs
effectively. The draft SITC report
suggests that pilot design and
development will be necessary to
identify cost effective solutions that can
be widely adopted by State agencies and
authorized vendors.
2. Peanut Butter and Legumes
The proposed rule would have added
18 ounces of peanut butter in Food
Package V to improve the intake of
several nutrients in the diets of pregnant
and breastfeeding women. The proposed
rule would also add legumes (dried
beans/peas or peanut butter) in Food
Package VI for postpartum women.
Canned beans were proposed as an
optional substitute for dry beans in
Food Packages III–VII. Of the 3,091
comment letters that addressed these
provisions, 3,085 commenters (21 form
letters)—a large majority of whom were
participants—were in favor of the
proposed changes.
Six commenters asked that FNS
eliminate peanut butter in the food
packages for children because of
concerns about peanut allergies. The
IOM advised that children should avoid
eating peanut butter from a spoon for
safety reasons until age 3, but
recommended that peanut butter
continue to be offered in the WIC food
packages for young children from 1 to
5 years of age. IOM has advised FNS
that assessing for allergies and tailoring
a young child’s food package based on
such assessment, as is current practice
in WIC, is appropriate.
Therefore, the proposed peanut butter
and legume provisions are retained in
this interim rule as proposed.
3. Milk and Milk Alternatives
a. Maximum Monthly Milk Allowances
The proposed rule would have
decreased the maximum monthly
allowances for milk in all food
packages—for children and postpartum
women, from 24 quarts to 16 quarts; for
pregnant and partially breastfeeding
women, from 28 to 22 quarts; and for
fully breastfeeding women, from 28
quarts to 24 quarts of milk. Reducing the
amount of milk provided through WIC
is consistent with recommended limits
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on saturated fat, total fat, and
cholesterol consumption put forth in the
DGA,(1) better aligns the amount of milk
provided by WIC with the amounts
recommended by the DGA(1) and is
consistent with the supplemental nature
of the WIC Program.
The majority of non-participant
commenters were in favor of the
proposed reductions in milk. A total of
2,088 non-participant commenters
(1,874 of which were form letters) were
supportive of the reductions, while 66
commenters were opposed. Commenters
opposing the reductions cited the
contribution of milk to intakes of
priority nutrients for WIC participants,
e.g., calcium, Vitamin A, and potassium.
Seventeen commenters stated that the
food package for postpartum women
should be increased to the levels
provided to pregnant and partially
breastfeeding women. Six commenters
urged FNS to maintain milk at current
levels and increase funding for other
proposed food package provisions.
Comment letters from program
participants reflected disappointment
with the reductions in milk. A total of
1,831 comment letters were received
from program participants who opposed
the reductions; 225 participants wrote
in favor of the proposed reductions.
FNS believes that the IOM set forth a
series of science-based
recommendations that, taken together,
balance the various supplemental
nutritional needs of participants.
According to the IOM, amounts of milk
provided by the WIC food packages
need not exceed amounts recommended
by the DGA.(1) The proposed dairy
levels for children (2 cups/day) and
pregnant and breastfeeding women (3
cups/day) provide at least 100 percent
of the servings recommended by the
DGA.(1) The level for non-breastfeeding
postpartum women is at least 2⁄3 of the
amount set forth by the DGA.(1) The
proposed maximum monthly allowance
of milk allows a more balanced food
package to provide the various high
priority nutrients within cost
constraints. Therefore, the proposed
maximum allowances for milk are
retained in this interim rule in Table 2
of 7 CFR 246.10(e)(10) and Table 3 of 7
CFR 246.10(e)(11).
b. Low-Fat Milk
Under the proposed rule, only whole
milk (not less than 3.25% milk fat)
would have been authorized for
children less than 2 years of age. For
children two years of age and older and
women, the proposed rule would have
authorized only milk with no more than
2% milk fat to be consistent with
current recommendations of the DGA
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2005 to limit saturated fat and dietary
cholesterol intake. A total of 3,058
commenters (2,663 of which were form
letters) agreed with the provisions as
written; 222 (10 of which were form
letters) were opposed. One hundred
seventy of those opposed were program
participants. A total of 1,379
commenters (1,338 of which were form
letters) stated that the fat content of milk
for children and women should be
reduced even further—to no more than
1% of milk fat.
Seventy-eight commenters (23 of
which were form letters) asked FNS to
allow the CPA the authority to prescribe
the type of milk (whole milk or low fat
milk) to participants, regardless of age
or category, if medically necessary for
such reasons as failure to thrive,
underweight or overweight. FNS’
position is that participants who have
medical conditions that lead to a
diagnosis of failure to thrive will likely
be issued Food Package III. Therefore, to
address commenters’ concerns, this
interim rule will authorize whole milk
for children 1 through 4 years of age and
women in Food Package III, with
medical documentation. As proposed,
only milk with no more than 2% milk
fat is authorized for children 2 years of
age and older and women in Food
Packages IV–VII. For these participants,
nutrition education directed towards
appropriate foods and food amounts
should be provided for underweight or
overweight participants. Nutrition
education and individual tailoring of
the food package within authorized
parameters remain the most effective
tools for WIC staff to use to help
participants make appropriate choices
based on their specific needs.
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c. Lactose Free Milk
Under the proposed rule, as long as a
milk conforms to the FDA standard of
identity for milk as defined by 21 CFR
Part 131 and meets WIC Federal
requirements, it would be an authorized
milk in Food Packages IV, V, VI, and
VII. Although not specified in the
proposed rule, authorized milks that
conform to the FDA standard of identity
include, but are not limited to, calciumfortified, lactose-reduced and lactosefree, acidified, and ultra-high
temperature (UHT) milks. FNS clarifies
that these products are authorized, and
that lactose-free or lactose-reduced dairy
products should be offered before nondairy milk alternatives to those
participants with lactose intolerance
who cannot drink milk. FNS also
clarifies that medical documentation is
not required for participants to receive
lactose-reduced and lactose-free milk.
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d. Authorized Substitutions for Milk
(Cheese, Tofu, Soy-Based Beverage)
(1) Cheese. The proposed rule would
have reduced the amount of cheese that
may be substituted for milk to one
pound per month for children and
pregnant, postpartum and partially
breastfeeding women, and two pounds
for fully breastfeeding women. Reducing
the amount of cheese that may be
substituted for milk will reduce
saturated fat and total fat intake by
children age two and older and women
consistent with the DGA(1)
recommendations. Amounts of cheese
that exceed the maximum substitution
amounts may be authorized with
medical documentation in cases of
lactose intolerance or other qualifying
conditions.
The majority of non-participant
commenters were in favor of the
proposed reduced cheese substitution
amounts. A total of 754 non-participant
commenters (of which 589 were form
letters) were supportive of the reduced
substitution amounts, while 53
commenters were opposed. A total of
917 comment letters were received from
program participants who opposed the
proposed cheese allowances; 119
participants wrote to express support for
the proposed amounts. Commenters
opposing the cheese substitution
amounts stated that cheese is culturally
acceptable to most populations, and
provides nutrients in a convenient and
familiar way. Fourteen commenters
asked FNS to maintain cheese at its
current substitution levels and
emphasize or require reduced-fat
cheese.
Reducing the maximum amount of
cheese lowers the amount of saturated
fat, total fat, and cholesterol in the WIC
food packages. Within the context of the
proposed revisions to the WIC food
packages as a whole, the reductions in
the current levels of cheese ensure that
FNS is able to provide a more balanced
nutrient intake for WIC participants
while maintaining cost neutrality.
Therefore, the proposed substitution
levels for cheese are retained in this
interim rule.
(2) Soy-based beverage and tofu. To
provide more flexibility for WIC State
agencies and more variety and choice
for WIC participants, the proposed rule
would have authorized soy-based
beverage to be substituted for milk for
women in Food Packages V, VI and VII
at the rate of 1 quart of soy-based
beverage for 1 quart of milk up to the
total maximum allowance of milk. The
proposal also would have allowed
calcium-set tofu to be substituted at the
rate of 1 pound of tofu per 1 quart of
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68973
milk. A maximum of 4 quarts of milk
could be substituted in this manner in
Food Packages V and VI, and a
maximum of 6 quarts of milk may be
substituted in Food Package VII. Under
the proposed rule, soy-based beverage
and tofu would not be allowed as
substitutes for milk for children in Food
Package IV without medical
documentation. The qualifying
conditions may include, but are not
limited to, milk allergy, severe lactose
maldigestion, and vegan diets. Amounts
of tofu that exceed the maximum
substitution amounts may be authorized
for women, with medical
documentation, in cases of lactose
intolerance or other qualifying
conditions.
A total of 8,932 commenters (4,615
form letters) were supportive of adding
soy-based beverage and tofu to the WIC
food packages as milk substitutes; 368
commenters (148 form letters) were not
supportive. Comments received on
medical documentation requirements
for soy-based beverage for children and
FNS’ rationale for retaining the
provision in this interim rule as initially
proposed are discussed in section
IV.B.4. of this preamble.
As stated in the preamble to the
proposed rule, Section 102 of the Child
Nutrition and WIC Reauthorization Act
of 2004 (Pub. L. 108–265) requires that
nondairy beverages offered as an
alternative to fluid milk in the National
School Lunch Program and School
Breakfast Program must be nutritionally
equivalent to fluid milk and meet
nutritional standards set by the
Secretary of Agriculture. FNS, therefore,
proposed that authorized soy-based
beverage provide, at a minimum, the
following nutrients:
Calcium .......
Protein .........
Vitamin A ...
Vitamin D ....
Magnesium ..
Phosphorus
Potassium ....
Riboflavin ....
Vitamin B12
276 milligrams (mg) per cup.
8 grams per cup.
500 International Units (IU)
per cup.
100 IU per cup.
24 mg per cup.
222 mg per cup.
349 mg per cup.
0.44 mg per cup.
1.1 mcg per cup.
A total of 340 commenters (255 form
letters) were opposed to the proposed
minimum nutrient standard, stating that
fortification at these levels is not
necessary, and that soy-based beverage
meeting the proposed minimum
nutrition standard are not available in
the marketplace. FNS believes that it is
imperative for WIC and the school
nutrition programs to use the same
standards for defining allowable soybased beverage as alternatives to fluid
milk. Therefore, the proposed minimum
nutrient standard for soy-based beverage
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is retained in this interim rule. FNS is
aware of at least one soy-based beverage
in the marketplace that meets these
requirements and anticipates that the
marketplace will respond with
additional products. To the extent that
the marketplace doesn’t respond with
additional products, other options, such
as tofu, are available for participants.
(3) Yogurt. The IOM recommended
adding yogurt to the WIC food packages
as a milk substitute for children and
women. However, in order to maintain
cost neutrality, the proposed rule did
not include yogurt. Of the 758
commenters that addressed yogurt, 749
(617 form letters) disagreed with FNS’
decision not to include yogurt.
Commenters stated that yogurt provides
priority nutrients, and is convenient,
popular, and culturally acceptable to
WIC participants.
FNS agrees that yogurt would be a
desirable dairy alternative to milk for
WIC participants; however, the cost is
simply prohibitive ($413.9 million over
5 years). In addition, FNS has
determined that WIC participants will
be able to get the calcium provided by
yogurt through other foods authorized
in these revised food packages. Lactosefree and lactose-reduced dairy products,
for example, are readily available in
both urban and rural areas for those WIC
participants with lactose intolerance.
Calcium-set tofu and soy-based
beverages are available to accommodate
cultural preferences. Also, as noted
earlier, a new 7 CFR 246.10(i) has been
added to this interim rule to allow State
agencies the flexibility to meet
unanticipated cultural needs of
participants.
It is important that revisions to the
WIC food packages be cost neutral to
protect the program’s ability to serve the
greatest number of eligible women,
infants, and children. Therefore, FNS is
unable to authorize yogurt in the WIC
food packages in this interim final rule.
However, FNS solicits comments from
State agencies as they implement the
provisions of this interim rule about the
extent to which WIC participants would
benefit from the addition of yogurt, and
whether that addition would be
achieved in a cost-effective way. In
particular, we are interested in the
impact of adding yogurt for women in
Food Packages V–VII.
FNS also solicits comments as to the
feasibility of rebate agreements between
yogurt manufacturers and individual
States, so that yogurt could be provided
to specific participant groups in the WIC
program while maintaining costneutrality. State agencies are currently
encouraged to explore the feasibility of
cost containment systems, especially
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rebates, and to implement such a system
where feasible for other WIC foods. In
an effort to use their food grants more
efficiently, 13 State agencies, which
include 3 multi-State contracts, have
rebate contracts for juice (frozen and
shelf), infant juice and/or infant cereal.
If FNS were to consider including
yogurt as a WIC-eligible food through
future rulemaking, FNS would be
interested in the following types of
information:
• Which participant groups would
most benefit from having yogurt
included as part of their food package?
• Would States be able to secure
rebates sufficient enough to add yogurt
for all or certain participant groups
while maintaining cost-neutrality?
Finally, and as noted earlier, Section
203(c) of Public Law 108–265 amended
Section 17(c)(2) of the Child Nutrition
Act of 1966, as amended (42 U.S.C.
1786), by requiring the Secretary to
conduct, as often as necessary, a
scientific review of supplemental foods
available under the program and to
amend the foods, as needed, to reflect
nutrition science, public health
concerns, and cultural eating patterns.
As such, future reviews of the WIC food
packages by FNS will be used to
determine the need for yogurt.
4. Eggs
Under the proposed rule, the
maximum monthly allowance for fresh
shell eggs would have been reduced
from the current 2 or 21⁄2 to 1 dozen
fresh shell eggs for children and women
in Food Packages IV, V, and VI. For
fully breastfeeding women in Food
Package VII, the maximum monthly
allowance was proposed at 2 dozen
eggs.
A total of 1,469 commenters (266 of
which were form letters) addressed the
proposed egg reduction provision. Of
the 492 non-participant commenters,
406 were in favor of the proposed
reductions. Those opposing stated that
eggs provide important nutrients at
relatively low cost. Of the 1,009
program participants who commented,
923 were opposed to the reduction in
eggs.
The proposed maximum monthly
allowance of eggs is consistent with
recommendations of the IOM (3) and the
DGA (1) to reduce cholesterol. In
addition, the IOM determined that
protein is no longer a priority nutrient
for the WIC population. Within the
context of the proposed revisions to the
WIC food packages as a whole, the
reductions in the current levels of eggs
ensures that FNS is able to provide a
more balanced nutrient intake for WIC
participants while maintaining cost
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neutrality. Therefore, the proposed
maximum monthly allowances for eggs
are retained in this interim rule.
5. Juice for Children and Adults
The proposed rule would have
reduced the maximum allowances of
juice for women and children in Food
Packages IV–VII. According to the IOM,
deleting or reducing the quantity of
juice in the WIC food packages helps
allow for the inclusion of whole fruits
and vegetables while containing food
costs, and is consistent with
recommendations of the DGA(1) and the
American Academy of Pediatrics (AAP).
For children, the proposed maximum
monthly allowance of juice would have
been reduced from 288 fluid ounces to
128 fluid ounces. For pregnant and
partially breastfeeding women, the
proposed maximum monthly allowance
of juice was reduced from 288 fluid
ounces to 144 fluid ounces; for
postpartum women from 192 fluid
ounces to 96 fluid ounces; and for fully
breastfeeding women, from 336 fluid
ounces to 144 fluid ounces.
A total of 2,256 commenters (846 form
letters) addressed the proposed
reductions in juice. Of these, 1,610
commenters (846 form letters) were
supportive of the juice reductions.
Eighty two of those commenters
recommended that juice be eliminated
entirely from the WIC food packages
and replaced with fruits and vegetables.
Of the 646 commenters that opposed the
reduction in juice, 633 were program
participants. Non-participant
commenters who opposed the
reductions cited the nutritional benefits
of juice and stated that the proposed
reductions were too drastic.
Reducing the quantity of juice in the
WIC food packages helps allow for the
inclusion of whole fruits and vegetables
while containing food costs. The
reduction in the amount of juice
provided for children to about 4 ounces
per day is consistent with the AAP
recommendation for that age group. The
AAP also notes that juice does not
provide any additional nutritional
benefit beyond that of whole fruit. The
reduced amount of juice for women is
consistent with the recommendation of
the DGA(1) that whole fruits be used for
a majority of the total daily amount of
fruit.
Additionally, 34 commenters (14 form
letters) expressed concern that juice
package sizes need to be considered to
ensure the full nutritional benefit of
juice is received by participants. Over
the years, there have been many changes
in package sizes for all WIC-eligible
food categories, and FNS has struggled
with how to manage these changes
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within WIC Program regulations that
allow for a monthly maximum
allowance of food that cannot be
exceeded (except for the rounding
option for infant formula and infant
foods). It is not practical for FNS to be
able to respond to all the variations in
package sizing. Basing the maximum
monthly allowance on package sizes
would not guarantee that those package
sizes will not change over time.
Therefore, FNS is retaining the
proposed maximum juice allowances for
children and women in this interim
rule.
6. Whole Grains and Breakfast Cereals
To support the DGA(1)
recommendations to consume at least 3
servings per day of whole grains to
reduce the risk of coronary heart disease
and type 2 diabetes, to help with body
weight maintenance, and to increase
intake of dietary fiber, the proposed rule
would have established a whole grain
requirement for breakfast cereal in Food
Packages III–VII and added whole wheat
bread or other whole grain options for
children and pregnant and breastfeeding
women in Food Packages III, IV, V and
VII.
The addition of whole grains to the
WIC food packages was popular across
all commenter categories. A total of
17,165 comment letters (7,983 form
letters) agreed with the whole grain
provisions and 113 comment letters (5
form letters) disagreed with the
provisions. While strongly supporting
FNS’ emphasis on whole grains, 876
commenters (764 form letters) expressed
concern that the proposed nutritional
requirement for whole grain breakfast
cereal—using labeling requirements for
making a health claim as a ‘‘whole grain
food with moderate fat content’’ as
defined by the Food and Drug
Administration (FDA) in its December 9,
2003, Health Claim Notification for
Whole Grain Foods with Moderate Fat
Content at https://www.cfsan.fda.gov/
∼dms/flgrain2.html—is too restrictive.
Commenters stated that the proposed
provision would eliminate corn and
rice-based cereals that are necessary for
participants with wheat allergies or
strong preferences for corn and ricebased cereals, as well as severely limit
the total variety and choice of WICeligible cereals. In addition, 77
commenters (21 form letters) also stated
that whole grain foods are less palatable
to young children, may not be preferred
by certain cultures, and therefore may
not be chosen by participants,
potentially negating FNS’ goal to help
participants increase whole grain
consumption. Additionally, commenters
pointed to (1) potential administrative
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difficulties in the identification of
whole wheat bread and whole grain
cereals by State agency staff when
determining which products are WICeligible; and (2) confusion by vendors
and participants at the point of purchase
due to lack of consistency in food labels
that do not clearly identify foods as
meeting the FDA standard of identity for
whole wheat bread or the labeling
requirement for making the health claim
as ‘‘a whole grain with moderate fat
content.’’
Commenters suggested several
alternatives for determining a
nutritional standard for whole grain
cereals including the elimination of any
requirement for whole grain, adoption
of an 8-gram per serving standard, and
exemption of certain cereals from the
whole grain requirement. FNS finds
merit in commenters’ concerns that the
proposed whole grain nutritional
requirement for breakfast cereal would
eliminate corn and rice-based cereals, as
well as severely limit the variety and
choice of WIC-eligible breakfast cereals;
and that whole grain breakfast cereals
may be less palatable to participants,
especially children, and less preferred
by certain cultures. WIC-eligible
breakfast cereals are the major source of
iron in the WIC food packages for
children and women and research
shows that participation in WIC has a
positive impact on the iron status of its
participants. The IOM pointed out that
despite declines in the prevalence of
iron-deficiency, this deficiency remains
a nutrition-related health risk for
children and women of reproductive
age.
Acceptability of eligible foods by
participants is an important factor in the
decision to authorize types and brands
of foods for State food lists and
therefore, in this interim rule, the
provision at 7 CFR 246.10(e)(12) is
revised to require that at least one half
of the total number of breakfast cereals
on the State’s authorized food list meet
the whole grain requirement using the
FDA labeling requirements for making a
health claim as a ‘‘whole grain food
with moderate fat content.’’ Further, to
assist in the identification of whole
grain cereals for State agencies, vendors
and participants, the interim rule adds
the requirement that the primary
ingredient by weight must be a whole
grain. The remaining authorized
breakfast cereals are required to meet
only the iron and sugar requirements.
State agencies may opt that all or more
than half of the cereals on the State’s
authorized food list meet the whole
grain requirement. However, in
establishing minimum requirements for
the variety and quantity of foods that a
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vendor must stock to be authorized,
State agencies must require that at least
one whole grain cereal be available.
FNS believes that the revisions to the
proposed whole grain provisions for
cereals in this interim rule will continue
to support the goals of the DGA(1) for
increasing whole grain consumption.
State agencies are reminded that 7 CFR
246.10(b)(1)(i) allows the State to
establish criteria in addition to the
minimum Federal requirements for WIC
supplemental foods, e.g., no artificial
sweeteners.
FNS also finds merit in commenters’
concerns about administrative
difficulties in the identification of
whole wheat bread and whole grain
products. It is important that WIC
nutritional requirements be simple and
accurate for State agencies to use when
determining foods to authorize for State
food lists and that authorized whole
wheat and whole grain products make
significant contributions of whole wheat
or whole grain to the WIC food
packages. Therefore, the proposed
requirements for whole wheat bread
—any bread that conforms to the FDA
standard of identity for whole wheat
bread as defined by 21 CFR 136.180 will
be retained in this interim rule.
However, to assist in the identification
of whole wheat bread products for State
agencies, vendors and participants, the
interim rule adds the requirement that
the primary ingredient by weight must
be whole wheat. FNS also clarifies in
this interim rule that whole wheat buns
and rolls that meet the FDA standard of
identity for whole wheat bread, and
have whole wheat as their primary
ingredient, are WIC-eligible.
The proposed requirements for whole
grain breads—any bread product that
meets labeling requirements for making
a health claim as a ‘‘whole grain food
with moderate fat content’’ as defined
by FDA in its December 9, 2003, Health
Claim Notification for Whole Grain
Foods with Moderate Fat Content at
https://www.cfsan.fda.gov/∼dms/
flgrain2.html—will also be retained in
this interim rule. However, the interim
rule adds the requirement that the
primary ingredient by weight must be
whole grain.
The revisions to the whole wheat and
whole grain bread requirements will
allow products that are 100% whole
grain, or are primarily whole wheat or
multi-grain, to be WIC-eligible as well as
provide an easy way for participants
and vendors to identify whole wheat
and whole grain bread products by
using the food label. The primary
ingredient is easily identified on the
food label since ingredients are listed in
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descending order of predominance by
weight.
To ensure that the whole grain
options are consistent with the intent of
the IOM recommendations, this interim
rule also clarifies that the brown rice,
bulgur (cracked wheat), oatmeal, and
barley (whole-grain) are the whole
unprocessed grain, and that soft corn
and whole wheat tortillas must have the
whole grain as the primary ingredient
by weight according to the food label. A
technical oversight in the proposed food
package rule has been corrected in this
interim rule by removing the
requirement that authorized soft corn or
whole wheat tortillas contain no added
fats or oils.
In the interim rule, State agencies will
continue to be responsible for
determining which types and brands of
whole wheat bread and whole grain
products and breakfast cereals to
authorize on State food lists using the
minimum requirements and
specifications in Table 4 at 7 CFR
246.10(e)(12). FNS will provide
information on label reading and
marketplace availability to State
agencies to assist in the identification of
whole wheat and whole grain foods and
on nutrition education that encourages
increased consumption of whole grains.
The assistance of industry is requested
in notifying FNS of whole wheat and
whole grain bread products, whole grain
cereals, and whole grain options that
may meet the newly established
nutritional requirements. Information
may be mailed or sent electronically to
FNS at the addresses provided at the
beginning of this preamble.
Maximum Monthly Allowance
The proposed rule would have
established a maximum monthly
allowance of 2 pounds of whole wheat
bread or other whole grain options for
children in Food Packages III and IV;
and 1 pound of whole wheat bread or
other whole grain options for women in
Food Packages III, V and VII. The rule
proposed a maximum monthly
allowance of 36 ounces of breakfast
cereal for children and women in Food
Packages III–VII. While supporting the
addition of whole wheat bread and
other whole grain options to the WIC
food packages, 95 comment letters (38
form letters) expressed concern that the
package sizes of bread are not
commonly available in either one- or
two-pound loaves and that the
participants would have difficulty
purchasing the maximum monthly
allowance for whole wheat bread. FNS
has long recognized that package sizes
of WIC-eligible foods vary among
manufacturers and those manufacturers
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may change package sizes at any time.
Over the years, there have been many
changes in package sizes for all WICeligible food categories, and FNS has
struggled with how to manage these
changes within WIC Program
regulations that allow for a monthly
maximum allowance of food that cannot
be exceeded (except for the rounding
option for infant formula and infant
foods). It is not practical for FNS to be
able to respond to all the variations in
package sizing. Basing the maximum
monthly allowance on package sizes
would not guarantee that those package
sizes will not change over time and,
therefore, the maximum monthly
allowance for whole wheat bread and
other whole grain options and breakfast
cereal remains as proposed.
7. Canned Fish
The proposed rule would have
authorized 30 ounces of a variety of
canned fish in Food Package VII for
fully breastfeeding women. The
following varieties of canned fish were
proposed—light tuna, salmon, and
sardines. In the proposed rule, FNS
solicited input on additional canned
fish to offer in Food Package VII.
A total of 3,546 commenters (26 form
letters) expressed support for the
proposed canned fish provisions; 555
commenters opposed. Of the opposing
comment letters received, 506 were
variations of one form letter submitted
as part of a letter writing campaign
initiated by an advocacy organization
concerned with the public’s exposure to
methylmercury. These and other
opposing commenters believe that
canned light tuna should be eliminated
from the WIC food packages until more
study is conducted on its mercury
content. Two commenters (1 form letter)
opposed the omission of albacore tuna
from the list of authorized varieties of
canned fish.
The IOM recommended that a variety
of canned fish that do not pose a
mercury hazard be offered in Food
Package VII. As identified by federal
advisories of the Food and Drug
Administration (FDA) and the U.S.
Environmental Protection Agency
(EPA),(4) canned light tuna, salmon, and
sardines are among those fish that are
lower in mercury. For ease of
administration by State agencies, to
accommodate participant preferences,
and to minimize intake of mercury, this
interim rule retains the proposed
varieties of canned fish in Food Package
VII for fully breastfeeding women. In
response to commenters’ requests,
canned mackerel—N. Atlantic and Chub
(Pacific)—also identified as lower in
mercury, has been added in this interim
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rule as an authorized canned fish in
Food Package VII.
8. Proposed Food Packages I and II for
Infants
The rule proposed the following
changes in Food Packages I and II for
infants:
• Revise age specifications for
assignment to infant food packages;
• Delay introduction of
complementary food to six months of
age;
• Establish 3 feeding options within
each infant food package—fully
breastfed, partially breastfed, or fully
formula fed;
• Revise maximum monthly infant
formula allowances;
• Add infant food fruits and
vegetables in Food Package II;
• Eliminate juice from both infant
food packages;
• Disallow provision of infant
formula for breastfed infants during the
first month after birth;
• Disallow low iron infant formula;
• Allow commercial infant food meat
for fully breastfed infants in Food
Package II; and
• Reassign infants with a qualifying
condition to proposed Food Package
III—Participants With Qualifying
Conditions—and authorize the issuance
of exempt infant formulas only in Food
Package III.
The proposed revisions to Food
Packages I and II for infants were
designed to better promote and support
the establishment of successful longterm breastfeeding among women who
choose that feeding method, address
differences in nutritional needs of
breastfed and formula fed infants,
address developmental needs of infants,
bring the infant food packages in line
with current infant feeding practice
guidelines from the AAP, and serve all
participants with certain medical
conditions under one food package to
facilitate efficient management of
medically fragile participants.
a. Food Package I for Infants Under Six
Months
Under current WIC regulations, a
maximum formula allowance is
specified for all infants assigned to Food
Package I, regardless of infant feeding
practice; WIC staff may tailor the
amount of formula to reflect the
individual needs of the infants. The
proposed rule would have extended the
age range of infants covered by Food
Package I by two months, thereby
delaying introduction of complementary
foods previously offered in this food
package (juice and cereal) until six
months of age. In proposed Food
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Package I, fully formula fed infants four
through five months of age would
receive a slightly increased amount of
infant formula to compensate in part for
the decrease in nutrients and calories
that results from the omission of juice
and infant cereal. Also, to more actively
support successful breastfeeding, the
proposed rule would set a maximum
formula amount for partially breastfed
infants in Food Package I that is roughly
half the maximum provided to fully
formula fed infants.
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b. Food Package II for Infants Six
Through Eleven Months
Under the proposed rule, the amounts
of formula and the amounts and type of
infant foods would vary by infant
feeding option. Infant food fruits and
vegetables would be added to Food
Package II, infant juice eliminated, and
maximum formula allowances reduced
for both partially breastfed and fully
formula fed infants.
The majority of commenters were
supportive of the revisions to the infant
food packages as proposed. The
discussion that follows pertains to those
provisions that received significant or
substantial opposing comments,
suggested alternatives, or requests for
clarifications. Provisions related to the
proposed food packages for infants that
are not addressed in this preamble did
not receive significant or substantial
public comments and are therefore
retained in this interim rule as
proposed.
c. Breastfeeding Provisions
The proposed food packages for
infants and women were designed to
strengthen WIC’s breastfeeding
promotion efforts and provide
additional incentives to assist mothers
in making the decision to initiate and
continue to breastfeed. The IOM’s threepronged approach to better promote and
support breastfeeding through the WIC
food packages was proposed. The
approach focuses on the market value of
the package for the mother/infant pair
for the first year after birth, addresses
differences in supplementary nutrition
needs of breastfed and formula fed
infants, and considers how to minimize
early supplementation with infant
formula through continued or increased
efforts to promote and support the
breastfeeding dyad.
Because early supplementation may
contribute to the short duration of
breastfeeding, only two infant feeding
options were recommended initially
after delivery—either full breastfeeding
or full infant formula-feeding. The IOM
recommended this approach because
physiology provides a strong basis for
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avoiding supplemental formula. The
amount of milk a breastfeeding woman
produces depends directly on how often
and how long she nurses. Providing
supplemental formula to a new
breastfeeding mother may interfere with
her milk production and success at
continued breastfeeding.
The differences in the proposed
packages for the mother-infant pairs
were based on differences in nutritional
needs. For example, fully breastfeeding
women require additional calories per
day during the first six months
postpartum as well as higher levels of
most vitamins and minerals. Thus, the
package for fully breastfeeding women
provides the most food energy and
nutrients, and the package for fully
formula-feeding women provides the
least. Similarly, starting at age six
months, the proposed package for fully
breastfed infants would have included
commercial infant food meats to add a
source of iron and zinc.
These proposed food package
changes, as recommended by the IOM,
were intended to strengthen WIC’s
efforts to promote and support
breastfeeding as the optimal infant
feeding choice for WIC mothers.
In general, commenters expressed
support for the proposed breastfeeding
provisions. Of the 1,057 commenters
(774 form letters) that made statements
regarding the breastfeeding provisions,
1,017 (753 form letters) were supportive
of the provisions, stating that they add
value and incentive for mothers to
breastfeed and support WIC’s efforts to
promote breastfeeding as the optimal
infant feeding choice.
The largest number of opposing
comments on the breastfeeding
provisions focused on those related to
the establishment of infant feeding
options the first month after birth, as
described below.
Establishment of Infant Feeding
Options—First Month After Birth
To support the successful
establishment of breastfeeding, the
proposed rule would have established
two infant feeding options for the first
month after birth, either full
breastfeeding or full formula-feeding.
Under the proposed rule, infant formula
would not be provided for fully or
partially breastfeeding infants during
the first month of life after birth. The
IOM recommended this approach
because providing supplemental
formula to a new breastfeeding mother
may interfere with her milk production
and success at continued breastfeeding.
A total of 862 commenters (540 form
letters) addressed this provision. Of
those, 195 commenters (102 form
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68977
letters) agreed with the provision as
written. A total of 667 commenters (438
form letters) were opposed. While
agreeing with its premise—that early
supplementation inhibits the
establishment of successful
breastfeeding in the critical early weeks
of an infants life—opposing commenters
expressed concern that some WIC State
and local agencies may not be prepared
to provide support services (peer
counselors, breast pumps, consultation
with lactation experts) to the extent
necessary to make this provision work
for every mother. As a result, a mother
who feels less than confident about her
ability to breastfeed may choose to
either (1) categorize her infant as fully
formula fed, thus receiving more
formula than is necessary for the
breastfeeding infant and further
compromising the establishment of
successful breastfeeding, or (2) not
breastfeed at all. Other commenters
pointed to legitimate medical reasons
that a breastfeeding mother/infant dyad
may have which result in the need for
supplemental formula in the early
postpartum period, such as infants with
metabolic disorders. Commenters urged
FNS to consider allowing State agencies
the option to provide a small amount of
infant formula during the first month in
limited situations.
FNS finds the arguments put forth by
commenters compelling. Therefore, the
provisions at 7 CFR 246.10(e)(1)(ii)(A)
and in Table 1 of 7 CFR 246.10(e)(9) are
revised as follows. Three infant feeding
options will be authorized in the first
month after birth—either (1) fully
formula feeding; (2) fully breastfeeding;
or (3) partially breastfeeding. As
proposed, no supplemental formula will
be provided for fully breastfeeding
infants. The third infant feeding
option—partially breastfeeding—will be
offered to the infant who is breastfed but
also receives not more than 104
reconstituted fluid ounces of formula
from the WIC program. Food Package V
will be provided to mothers of these
partially breastfeeding infants.
Partially breastfed infants ages 0 to 1
month may receive the equivalent of not
more than 104 fluid ounces of
reconstituted infant formula. This will
allow State agencies to issue one can of
powder infant formula commonly used
in WIC, and is responsive to
commenters’ requests to make a small
amount of infant formula available for
partially breastfeeding infants in the
first month. Powder infant formula is
recommended until the partially
breastfed infant reaches four months of
age due to its longer shelf life and to
minimize waste. The CPA is expected to
individually tailor the amount based on
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the carefully assessed needs of the
individual breastfeeding infant. This
means that mothers of partially
breastfed infants should not
‘‘automatically’’ be provided a can of
formula in the first month of life. If,
after a careful assessment, the CPA
determines that some formula is
appropriate for the infant in the first
month, the mother should be advised on
the appropriate amount of that one can
of formula to feed the infant. The goal
is to provide as minimal amount of
supplemental formula as is needed,
while offering counseling and support,
in order to help the mother establish a
successful milk supply.
FNS is aware that adequate
breastfeeding support for mothers is
important for the success of both the
partially and fully breastfeeding options
in the first month after birth. FNS is
committed to strengthening WIC’s
efforts to promote and support
breastfeeding, through the provision of
peer counseling funding to State
agencies and other means. Judicious use
of NSA funds by State agencies directed
toward research-based support known
to be effective—i.e., peer counseling,
consultation with lactation experts—
will further enhance the ability of State
and local agencies to assist mothers in
establishing and continuing successful
breastfeeding in the critical weeks after
birth and beyond. FNS’ view is that the
provision of a small amount of formula
for certain infants in the first month of
life is a temporary option that State
agencies may invoke to assist
breastfeeding mothers who may
otherwise choose to fully formula feed.
FNS expects that the proportion of
participants offered the partially
breastfeeding option in the first month
will decrease over time as State agencies
strengthen their breastfeeding support
infrastructure.
d. Maximum Monthly Allowances of
Infant Formula
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Under the proposed rule, the
maximum monthly allowance of infant
formula would be revised from current
levels to reflect the proposed feeding
options (fully formula feeding, partially
breastfeeding, and fully breastfeeding),
physical form of infant formula
provided (liquid concentrate, powder,
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or ready-to-feed), and the age of the
infant. A total of 574 commenters (143
form letters) addressed the maximum
monthly allowances of infant formula.
Two hundred forty four commenters
were opposed to changes in the
maximum monthly allowances; of these,
148 were program participants. The
majority of comments centered on two
specific issues: (1) The variation in
amounts of formula provided during the
different age specifications; and (2) a
decrease in amount of formula available,
especially for the 6–12 month old
infant. Non-participant commenters in
opposition to revising formula
allowances stated that reducing formula
will result in supplementation with
whole milk or inappropriate liquids.
Some non-participant commenters
stated that formula amounts should stay
the same as in current regulations and
the CPA should tailor the packages as
appropriate for the needs of individual
infants. Participant commenters
expressed concern that formula is
expensive and if WIC reduces the
amount provided it will increase their
out-of-pocket expenses to purchase the
additional formula.
The proposed maximum formula
allowances for infants were determined
based on a scientific review of the
calorie and nutrient needs of infants at
different ages. The proposed amounts of
infant formula for partially
breastfeeding infants in Food Packages I
and II are designed to enhance the
promotion and support of breastfeeding.
The provision is part of the IOM’s
comprehensive approach resulting from
thorough consideration of scientific
research and public comments on how
to promote and support breastfeeding.
The maximum amount for partially
breastfed infants provides
approximately half the amount provided
to fully formula fed infants—to provide
about half of the infant’s nutritional
needs to encourage the mother to
breastfeed enough to provide at least
half of the infant’s nutritional needs.
This approach is preferable to current
tailoring because it establishes a
standard procedure that promotes
breastfeeding as the optimal way to feed
infants across WIC programs. The
addition of infant foods, along with the
proposed amount of formula for infants
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in Food Package II, provides close to
recommended amounts of nutrients,
introduces more variety into the infant’s
diet and encourages healthy dietary
patterns. FNS believes that the nutrition
education and anticipatory guidance on
infant feeding provided by WIC local
agencies will enable participants and
caregivers to make informed choices
about appropriate liquids for infants.
Other commenters asked for
clarification on the maximum monthly
allowances of infant formula per
physical form and suggested that the
maximum monthly allowance for infant
formula be the same for all physical
forms. The IOM recommended a
maximum monthly allowance of liquid
concentrate but stated that powder or
ready-to-feed formula (RTF) may be
substituted for liquid concentrate at
rates that provide the approximate
number of fluid ounces as the liquid
concentrate. The IOM recommended
rounding to whole cans to approximate
the target amount. FNS recognizes that
powder infant formula is an
increasingly popular physical form with
WIC agencies and participants. In
determining the amount of powder
formula to authorize, FNS considered
the cans sizes commonly used in WIC,
their reconstituted yields, and the range
of dry powder ounces recommended by
the IOM. The maximum monthly
allowance of powder infant formula
provides at least the number of fluid
ounces as the same reconstituted liquid
concentrate for the 3 major milk-based
infant formulas manufactured that State
agencies issue, thereby ensuring a
minimum level of nutrition for infants
regardless of physical form.
As described in section C.8.c. of this
preamble, partially breastfed infants
ages 0 to 1 month may receive the
equivalent of not more than 104 fluid
ounces of reconstituted infant formula.
This will allow State agencies to issue
one can of powder infant formula
commonly used in WIC, and is
responsive to commenters’ requests to
make a small amount of infant formula
available for partially breastfeeding
infants in the first month. The
maximum allowances of infant formula
for infants 1 month and older in Food
Package I and II are retained in this
interim rule as proposed.
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EXHIBIT A.—MAXIMUM MONTHLY ALLOWANCES FOR FOOD PACKAGE I FOR INFANTS AGES BIRTH TO 6 MONTHS, BY
FEEDING OPTION
Fully breastfed infants
Partially breastfed infants
WIC food
Fully formula fed infants
0 through 5
months
Infant Formula ......
Birth to one
month
1 through 3
months
4 through 5
months
0 through 3
months
4 through 5
months
NA ........................
104 fl oz reconstituted powder.
364 fl oz reconstituted liquid concentrate*.
442 fl oz reconstituted liquid concentrate.
806 fl oz reconstituted liquid concentrate.
884 fl oz reconstituted liquid concentrate.
NA= not applicable.
* The maximum monthly allowance is specified in the liquid concentrate form; however, powder and RTF are allowable substitutes and the
powder form is recommended for partially breastfed infants, ages 0 through 3 months of age.
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Two technical oversights in the
proposed food package rule have been
corrected in this interim rule by
adjusting the maximum monthly
allowance of RTF formula in Food
Package I.A. from 800 fluid ounces to
832 fluid ounces, and in Food Package
II.A. from 364 fluid ounces to 384 fluid
ounces.
e. Elimination of Juice for Infants and
Addition of Infant Foods in Food
Package II
A total of 629 commenters (69 form
letters) addressed the elimination of
juice from the infant food packages. The
majority of commenters were in
agreement with the provision to
eliminate juice from the infant food
packages, stating that juice is not
nutritionally valuable or necessary for
infants. A total of 242 commenters were
opposed; 228 of those opposed were
program participants. Twelve nonparticipant commenters stated that the
elimination of juice may lead to
substitution of lower-cost sweetened
beverages. The IOM specifically
recommended that infant food fruits and
vegetables replace juice for infants 6
through 12 months of age. An important
part of the nutrition education provided
by WIC staff to parents and caregivers of
infant participants’ is information on
the timing and types of complementary
foods appropriate for infants.
The addition of jarred infant foods
(fruits, vegetables, meat) to Food
Package II was well received by
commenters. Of the 5,953 commenters
that addressed infant foods, 5,887
commenters (of these, 131 were form
letters) expressed support for the
addition of infant foods. Those that
opposed asked that fresh, canned, or
frozen fruits and vegetables be allowed
in Food Package II instead of, or as an
option, to jarred infant foods. Some of
these commenters believe that jarred
infant foods are environmentally
wasteful and costly. Others stated that
the provision of jarred foods
undermines nutrition education
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messages about home prepared foods for
infants. Some commenters stated that
providing a cash value voucher for fruits
and vegetables for infants 9–12 months
of age may be more developmentally
appropriate for this age group.
The IOM specifically recommended
‘‘commercial baby food fruits and
vegetables and fresh bananas’’ for (1)
early introduction to new flavors and
textures over time; (2) nutrient content;
(3) availability in developmentally
appropriate textures; and (4) food safety.
Further, the provision of commercial
baby food fruits and vegetables helps
ensure that these items are consumed by
infants and not other participants, an
important consideration since the
amount of infant formula in Food
Package II is reduced from current levels
and replaced with complementary
infant foods. Therefore, the proposed
provisions about jarred infant foods in
Food Package II are retained in this
interim rule. FNS does not believe that
the provision of jarred infant foods is
incompatible with the nutrition
education provided by WIC staff related
to appropriate food choices and home
preparation of foods for infants since the
amount of infant foods provided by WIC
is supplemental to an infant’s entire
needs.
(1) Authorized infant meat. A
technical oversight in the proposed rule
has been corrected in this interim rule
by clarifying the minimum requirements
and specifications for authorized infant
meat as—any variety of commercial
infant food meat or poultry, as a single
major ingredient, with added broth or
gravy. Added sugars or salt (i.e. sodium)
are not allowed. Texture may range from
pureed through diced.
(2) Infant cereal. As proposed, the
maximum quantity of infant cereal was
not changed from current WIC
regulations. Thirteen commenters
believe that the amount of infant cereal
should be reduced. These commenters
stated that in their experience infants
did not eat the volume of infant cereal
provided by WIC. The IOM
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recommended that the amount of ironfortified infant cereal for infants six
months and older remain at 24 ounces.
Therefore, the proposed maximum
amount of infant cereal is retained in
this interim rule.
f. Rounding Up of Infant Foods
Public Law 108–265, the Child
Nutrition and WIC Reauthorization Act
of 2004, enacted on June 30, 2004,
contains a provision that allows a State
agency to round up to the next whole
can of infant formula to allow all
participants to receive the fullauthorized nutritional benefit specified
by regulation. This provision only
applies to infant formula (not exempt
infant formula or WIC-eligible medical
foods) issued as a result from a
solicitation bid on or after October 1,
2004. The proposed rule described the
‘‘full-authorized nutritional benefit’’ as
well as a methodology that State
agencies would be required to use if
choosing to implement the option to
round up. Consistent with the authority
allowing State agencies to round up
infant formula, FNS proposed rounding
up of infant foods (infant cereal, fruit,
vegetables and meat) to provide
administrative flexibility to State
agencies to ensure that infants would
receive the full nutritional benefit
recommended by the IOM.
Of the 139 comments received on this
issue, 129 commenters (66 form letters)
disagreed with the proposed
methodology for rounding up. Seventyseven commenters (40 form letters)
stated that the proposed methodology
was confusing and time-consuming to
calculate. Twenty-four commenters (21
form letters) urged FNS to allow State
agencies to determine their own
methodology for rounding up. FNS is
sensitive to commenters’ concerns and
will further assist State agencies that
choose to implement the option to
round up. FNS believes, however, that
a standard methodology for rounding
up, uniformly applied across State
agencies, is imperative. Therefore, the
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rounding up provisions are retained in
this interim rule as proposed, except
that this interim rule clarifies that the
full nutritional benefit for infant
formula is provided as a minimum on
average during the timeframe that the
food package is provided. This means
that when the rounding methodology is
applied, in some months participants
will receive less than the full nutritional
benefit amount, and other months will
receive more; however, on average,
participants will receive the full
nutritional benefit. The full nutritional
benefit is defined as the maximum
monthly allowance of reconstituted
fluid ounces of liquid concentrate infant
formula for the food package category
and feeding option, e.g. partially
breastfed infants 4 through 5 months of
age.
9. Revisions in Food Package III and
Their Effect on Food Packages I and II
Under proposed Food Package III,
infants with qualifying conditions
would be added and other supplemental
foods would be authorized. The
revisions were intended to provide
flexibility in accommodating the wide
range of nutritional needs of
participants served by this food
package, and facilitate the efficient
management and tracking of the costs of
providing supplemental foods to
persons with the most serious medical
conditions. Of the 86 comment letters
that addressed the proposed revisions to
Food Package III, 74 commenters (38
form letters) agreed with the proposed
changes, especially the addition of
supplemental foods other than WIC
formula, cereal and juice that are
currently authorized. Twelve
commenters (5 form letters) disagreed
with the proposed revisions.
Commenters remarked on a few specific
provisions. While agreeing with the
majority of provisions, 21 commenters
(19 form letters) from State and local
agencies asked that FNS clarify the
scope of Food Package III since infants
receiving an exempt infant formula for
a medical condition would now be
served under that package rather than
under Food Packages I and II as in
current regulations. These same
commenters wanted clarification on the
qualifying conditions that would allow
a participant to receive Food Package III.
FNS realizes that serving infants with
certain medical conditions under Food
Package III rather than under Food
Packages I and II will be a major change
for WIC staff. As stated in the preamble
of the proposed rule, only infant
formula would be authorized in Food
Packages I and II. Infant formula is a
food substitute for human milk for
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generally healthy, full-term infants.
Infant formula includes milk-based, soybased and lactose-free products.
Therefore, infants served under Food
Packages I and II will be generally
healthy, full-term infants. Conversely,
infants with a serious nutritionallyrelated medical condition that requires
an exempt infant formula or WICeligible medical food would be served
under Food Package III. Women and
children with serious medical
conditions would also be served under
Food Package III. FNS reminds readers
that the WIC Works Formula Database,
https://www.nal.usda.gov/wicworks
provides helpful information on the
identification and indications for use of
infant formulas, exempt infant formulas
and WIC-eligible medical foods.
Commenters were also concerned
about medically fragile infants 6 months
of age or greater whose medical
condition prevents them from
consuming complementary infant foods.
Commenters requested that these infants
receive more WIC formula in
replacement of the nutrition that would
result from the addition of
complementary foods. FNS finds merit
in this concern and therefore will revise
the provision in Table 1 of 7 CFR
246.10(e)(9) to allow medically fragile
infants 6 months of age or greater whose
medical condition prevents them from
consuming complementary infant foods
(cereal, fruit and vegetables, and meat)
to receive exempt infant formula or
WIC-eligible medical foods at the same
maximum monthly allowance as infants
ages 4 through 5 months of the same
feeding option. The provision of exempt
infant formula or WIC-eligible medical
foods for these infants is in lieu of
provision of complementary infant
foods.
In the proposed rule, FNS requested
comments on WIC-eligible medical
foods. Of the 36 comments received, 21
commenters (14 form letters) agreed
with the WIC-eligible medical food
provisions and 15 (all form letters)
disagreed. As discussed in section IV.A.
of this preamble, commenters disagreed
with the proposed definition for WICeligible medical foods.
Of the 27 commenters (14 form
letters) who addressed ways to
determine nutritional equivalency for
other than liquid forms of ready-to-feed
(RTF) medical foods, e.g. bars and
puddings, 17 commenters (14 form
letters) recommended that protein
equivalents be used and 10 commenters
felt that the CPA, in consultation with
the health care provider, should
determine the amount of WIC-eligible
medical foods to prescribe, based on a
thorough nutritional assessment. One
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commenter also suggested that FNS
consider a serving per day equivalent.
FNS has determined that more
information is needed about nutritional
equivalency for other than liquid RTF
forms of WIC-eligible medical foods.
FNS will consult with experts from
industry as well as the FDA prior to
developing guidance for WIC agencies
on ways to determine nutritional
equivalency for various physical forms
of WIC-eligible medical foods.
D. Implementation Timeframe for
Revised Food Packages
FNS proposed a one-year
implementation timeframe for the
majority of the revisions to the WIC food
packages, with the following
exceptions—(1) a six-month timeframe
was proposed for the elimination of
juice for infants; and (2) a limitation was
proposed on the ability to implement
the partially breastfeeding food
packages for infants and women to not
more than 32 sites within up to eight
selected State agencies so that FNS
could examine the effects of the
revisions on the initiation and duration
of breastfeeding before allowing full
implementation by all State agencies.
Of the 203 commenters (137 form
letters) who addressed the proposed
one-year implementation of the revised
food package changes for pregnant,
postpartum, and fully breastfeeding
women, fully formula fed and fully
breastfeeding infants, children, and
participants with certain medical
conditions, 191 commenters (135 form
letters) were opposed. Commenters
asked for a longer implementation
timeframe due to the complexity of the
provisions, changes to management
information systems, and training needs
of staff, vendors and participants. FNS
is, therefore, extending the timeframe
for implementation of these new food
packages to 18 months after the effective
date of this interim rule.
A total of 611 commenters (501 form
letters) addressed the proposed
implementation plan for the partially
breastfeeding food packages for infants
and women. Of these, 590 commenters
(501 form letters) were strongly opposed
to the plan. Commenters stated that
deferring access to these packages
denies WIC Programs a vital tool to
encourage women to breastfeed and
unnecessarily delays participant access
to the proposed improvements in these
food packages. Commenters also
expressed concern that offering both
new and old food packages for up to 3
years after implementing the new food
packages would create an administrative
burden for State agencies and could
cause confusion for WIC participants.
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Finally, commenters pointed out that
under the proposed implementation
plan, partially breastfed infants 6
months to 11 months old could receive
more infant formula than fully formula
fed infants.
In light of the viewpoints expressed
by commenters, and as a result of
further review and determination by
FNS, the implementation timeframe for
the partially breastfeeding food
packages for infants and women is
revised to be concurrent with
implementation of the other food
packages—18 months from the effective
date of this interim rule. FNS remains
committed to examining the impact of
the significant changes to these food
packages on the breastfeeding mother/
infant dyad, and is developing a study
design that allows an assessment of the
effects of these changes without
delaying national implementation. In
addition, FNS encourages State WIC
agencies to examine the impact of these
food package changes in the first month
following birth on breastfeeding
initiation, intensity and duration and to
share the results with FNS and the WIC
community.
The following chart summarizes the
revised implementation timeframes for
all food package changes.
TIMELINES FOR IMPLEMENTATION OF FOOD PACKAGE CHANGES
Food package category
Who must implement
Pregnant Women ..............................................................
Postpartum Women ..........................................................
Fully Breastfeeding Women .............................................
Partially Breastfeeding Women ........................................
Fully Formula fed Infants ..................................................
Partially Breastfed Infants .................................................
Fully Breastfed Infants ......................................................
Juice Elimination from Infant Food Packages ..................
Children .............................................................................
Participants with Certain Medical Conditions (Women,
Infants and Children).
During the 18-month phase-in period,
State agencies are required to issue food
benefits based on either the new food
packages or current food packages but
may not combine the two. For example,
a State agency may not add whole wheat
bread and fresh fruits and vegetables to
the current foods and quantities
available under the children’s food
package. The State agency may,
however, phase-in the new food
packages on a participant category basis.
To minimize participant and vendor
confusion, once the State agency begins
issuing the new food packages, it must
be done on a Statewide basis. FNS will
collaborate with the National WIC
Association on developing
recommendations and options for
rolling out the new food packages, based
on ease of administration and other
issues. State agencies must, however,
roll out the food packages for the
partially breastfeed mother/infant dyad
concurrently, and are also strongly
encouraged to concurrently roll out the
food packages for the fully breastfed
mother/infant dyad.
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V. Endnotes
(1) U.S. Department of Health and Human
Services/U.S. Department of Agriculture,
Dietary Guidelines for Americans, 2005.
Available at Internet site: https://
www.healthierus.gov/dietaryguidelines/.
(2) Institute of Medicine, National
Academy of Sciences. ‘‘WIC Food Packages:
Time for a Change,’’ 2005. Available at
Internet site: https://www.fns.usda.gov/oane/
menu/Published/WIC/FILES/
Time4AChange(mainrpt).pdf.
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All
All
All
All
All
All
All
All
All
All
State
State
State
State
State
State
State
State
State
State
Agencies
Agencies
Agencies
Agencies
Agencies
Agencies
Agencies
Agencies
Agencies
Agencies
Timeframe for implementation
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
18
18
18
18
18
18
18
18
18
18
Months
Months
Months
Months
Months
Months
Months
Months
Months
Months
(3) Institute of Medicine, National
Academy of Sciences, 2002a. Dietary
Reference Intakes for Energy, Carbohydrate,
Fiber, Fat, Fatty Acids, Cholesterol, Protein,
and Amino Acids. Washington, DC: National
Academy Press.
(4) Environmental Protection Agency/Food
and Drug Administration. ‘‘What You Need
to Know About Mercury in Fish and
Shellfish.’’ EPA and FDA Advice for: Women
Who Might Become Pregnant, Women Who
Are Pregnant, Nursing Mothers, and Young
Children. 2004. Available at Internet site:
https://www.cfsan.fda.gov/dms/
admehg3.html.
VI. Procedural Matters
Executive Order 12866
This interim rule has been determined
to be economically significant and was
reviewed by the Office Management and
Budget in conformance with Executive
Order 12866.
Regulatory Impact Analysis
As required for all rules that have
been designated as Significant by the
Office of Management and Budget, a
Regulatory Impact Analysis (RIA) was
developed for this interim rule. It
follows this regulation as an Appendix.
The conclusions of this analysis are
summarized below.
Need for Action. As the population
served by WIC has grown and become
more diverse over the last 20 years, the
nutritional risks faced by participants
have changed, and though nutrition
science has advanced, the WIC
supplemental food packages have
remained largely unchanged. A rule is
needed to implement recommended
PO 00000
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Fmt 4701
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from
from
from
from
from
from
from
from
from
from
Effective
Effective
Effective
Effective
Effective
Effective
Effective
Effective
Effective
Effective
Date
Date
Date
Date
Date
Date
Date
Date
Date
Date
of
of
of
of
of
of
of
of
of
of
Interim
Interim
Interim
Interim
Interim
Interim
Interim
Interim
Interim
Interim
Rule.
Rule.
Rule.
Rule.
Rule.
Rule.
Rule.
Rule.
Rule.
Rule.
changes to the WIC food packages based
on the current nutritional needs of WIC
participants and advances in nutrition
science.
Benefits. Benefits of this rule include
bringing the WIC food packages in line
with the Dietary Guidelines for
Americans(1) and current infant feeding
practice guidelines of the American
Academy of Pediatrics, better promoting
and supporting the establishment of
successful long-term breastfeeding,
providing WIC participants with a wider
variety of food, providing WIC State
agencies with greater flexibility in
prescribing food packages to
accommodate participants with cultural
food preferences, and serving all
participants with certain medical
conditions under one food package to
facilitate efficient management of
medically fragile participants.
Costs. FNS estimates that the
provisions in this interim rule will have
minimal impact on total costs over 5
years.
Regulatory Flexibility Act
This interim rule has been reviewed
with regard to the requirements of the
Regulatory Flexibility Act (5 U.S.C 601–
612). Nancy Montanez Johner, Under
Secretary, Food, Nutrition and
Consumer Services, has certified that
this rule will not have a significant
economic impact on a substantial
number of small entities. State and local
agencies and WIC participants will be
most affected by the rule and WIC
authorized vendors and the food
industry may be indirectly affected.
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Although not required by the
Regulatory Flexibility Act, FNS has
prepared a Regulatory Flexibility
Analysis (RFA) describing the impact of
this interim rule on small entities. The
RFA reflects comments that were
received on the Initial Regulatory
Flexibility Analysis that was included
in the WIC Food Package Proposed Rule
published at 71 FR 44784. Additional
analysis of the regulatory flexibility
considerations of this interim rule may
be found in the Regulatory Impact
Analysis section of this preamble and
the cited RIA itself.
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Need For, and Objectives of, the Interim
Rule
This interim rule revises regulations
governing the WIC food packages to
change the maximum monthly
allowances and minimum requirements
for certain supplemental foods, and add
new foods such as fruits, vegetables and
whole grains. The revisions largely
reflect recommendations made by the
Institute of Medicine of the National
Academies in its Report ‘‘WIC Food
Packages: Time for a Change.’’ (2) These
revisions bring the WIC food packages
in line with the Dietary Guidelines for
Americans(1) and current infant feeding
practice guidelines of the American
Academy of Pediatrics, better promote
and support the establishment of
successful long-term breastfeeding,
provide WIC participants with a wider
variety of food, and provide WIC State
agencies with greater flexibility in
prescribing food packages to
accommodate participants with cultural
food preferences.
Description and Estimate of Number of
Small Entities To Which the Interim
Rule Would Apply
This interim rule applies to WIC State
agencies with respect to their selection
of foods to be included on their food
lists. As a result, vendors will be
indirectly affected and the food industry
will realize increased sales of some
foods and decreases in other foods, with
an overall neutral effect on sales
nationally. The rule may have an
indirect economic affect on certain
small businesses because they may have
to carry a larger variety of certain foods
to be eligible for authorization as a WIC
vendor. Currently, approximately
46,000 stores are authorized to accept
WIC food instruments, some of which
are small businesses. With the high
degree of State flexibility allowable
under this interim rule, small vendors
will be impacted differently in each
State depending upon how that State
chooses to meet the new requirements.
It is, therefore, not feasible to accurately
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estimate the rule’s impact on small
vendors. Since neither FNS nor the
State agencies regulate food producers
under the WIC Program, it is not known
how many small entities within that
industry may be indirectly affected by
the interim rule.
Description of Projected Reporting,
Recordkeeping, and Other Compliance
Requirements
This interim rule provides State
agencies with greater flexibility in
prescribing food packages to WIC
participants. The information collection
burden estimated for this rule is 14,598
hours. The burden reflects requirements
associated with medical documentation
for the issuance of any supplemental
foods issued to participants who receive
Food Package III; any authorized soybased beverage or tofu issued to
children who receive Food Package IV;
and, any additional authorized tofu and
cheese issued to women who receive
Food Packages V and VII that exceeds
the maximum substitution rate.
Steps Taken To Minimize Significant
Economic Impact on Small Entities, and
Significant Alternatives Considered
FNS has considered significant
alternatives in developing this interim
rule including those that may reduce the
indirect impact on small business.
These considerations include (among
others) the establishment of differing
compliance or reporting requirements or
timetables that take into account the
resources available to small entities; the
clarification, consolidation, or
simplification of compliance and
reporting requirements under the rule
for small entities; the use of
performance, rather than design,
standards; and an exemption from
coverage of the rule, or any part thereof,
for small entities.
In general, the alternatives of
exempting small entities from the
requirements in this interim rule or
altering the requirements for small
entities were rejected. The WIC food
packages provide supplemental foods
designed to address the nutritional
needs of low-income pregnant,
breastfeeding, non-breastfeeding
postpartum women, infants and
children up to age five who are at
nutritional risk. Exempting small
entities from providing the specific
foods intended to address the
nutritional needs of participants or
altering the requirements for small
entities would undermine the purpose
of the WIC Program and endanger the
health status of participants.
FNS has, however, modified the new
food provision in an effort to mitigate
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the impact on small entities. Currently,
State agencies must establish minimum
requirements for the variety and
quantity of foods that a vendor must
stock in order to receive WIC Program
authorization. This rule adds new food
items, such as fruits and vegetables and
whole grain breads, which may require
some WIC vendors, particularly smaller
stores, to expand the types and
quantities of food items stocked in order
to maintain their WIC authorization. In
addition, vendors also have to make
available more than one food type from
each WIC food category, except for the
categories of peanut butter and eggs,
which may be a change for some
vendors. To mitigate the impact of the
fruit and vegetable requirement, the rule
allows canned, frozen and dried fruits
and vegetables to be substituted for
fresh produce.
Federal Rules That May Duplicate,
Overlap, or Conflict With the Interim
Rule
There are no Federal rules that may
duplicate, overlap, or conflict with the
provisions of this interim rule.
Public Law 104–4, Unfunded Mandates
Reform Act of 1995 (UMRA)
Title II of the UMRA establishes
requirements for Federal agencies to
assess the effects of their regulatory
actions on State, local, and tribal
governments and the private sector.
Under Section 202 of the UMRA, FNS
generally must prepare a written
statement, including a cost/benefit
analysis, for proposed and final rules
with ‘‘Federal mandates’’ that may
result in expenditures to State, local, or
tribal governments, in the aggregate, or
to the private sector, of $100 million or
more in any one year. When such a
statement is needed for a rule, section
205 of the UMRA generally requires
FNS to identify and consider a
reasonable number of regulatory
alternatives and adopt the least costly,
more cost-effective or least burdensome
alternative that achieves the objectives
of the rule.
This interim rule contains no Federal
mandates (under the regulatory
provisions of Title II of the UMRA) that
impose costs on State, local, or tribal
governments or to the private sector of
$100 million or more in any one year.
This rule is, therefore, not subject to the
requirements of sections 202 and 205 of
the UMRA.
Executive Order 12372
The Special Supplemental Nutrition
Program for Women, Infants and
Children (WIC) is listed in the Catalog
of Federal Domestic Assistance under
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No. 10.557. For reasons set forth in the
final rule in 7 CFR part 3015, Subpart
V and related Notice (48 FR 29114, June
24, 1983), this Program is included in
the scope of Executive Order 12372,
which requires intergovernmental
consultation with State and local
officials.
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Federalism Summary Impact Statement
Executive Order 13132 requires
Federal agencies to consider the impact
of their regulatory actions on State and
local governments. Where such actions
have federalism implications, agencies
are directed to provide a statement for
inclusion in the preamble to the
regulations describing the agency’s
considerations in terms of the three
categories called for under section
(6)(b)(2)(B) of Executive Order 13132.
Prior Consultation With WIC State and
Local Agency Officials
Over the years FNS has received
numerous requests from WIC State and
local agencies to modify the current
food packages to permit greater
substitution of foods or introduction of
additional foods. These requests have
come from formal and informal
discussions and with State and local
officials on an ongoing basis regarding
program implementation and food
package policy issues, and from written
proposals and comments submitted to
FNS by WIC State and local agencies to
allow modifications and/or
substitutions to the WIC food packages.
Requests for revisions to the WIC food
packages have also been received from
Congress, participants, and
organizations with interests in the
welfare of WIC participants.
Examples of the different forums and
methods FNS has used over the years to
solicit WIC State and local agency staff
input on the WIC food packages include
the following.
• Publishing an advanced notice of
proposed rulemaking (ANPR) in 2003 to
solicit comments to determine if the
WIC food packages should be revised to
better improve the nutritional intake,
health and development of participants;
and, if so, what specific changes should
be made to the food packages. In
response to the ANPR, FNS received
195 total comments;
• Commissioning the National
Academies’ Institute of Medicine (IOM)
to independently review the WIC Food
Packages. IOM solicited public
comment on revisions to the WIC food
packages, via 3 public hearings, letters
and e-mail, throughout its 22-month
study period. IOM considered these
comments, as well as comments FNS
received in response to the ANPR, in
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developing recommendations to revise
the WIC food packages. IOM published
its reports of these recommendations on
April 27, 2005: ‘‘WIC Food Packages:
Time for a Change.’’ (2) This rule
incorporates IOM’s recommendations;
• Hosting annual meetings (1977present) of the National Advisory
Council on Maternal, Infant and Fetal
Nutrition that includes WIC staff as
members of the Council; the Council
develops recommendations for FNS on
how to improve operations of the WIC
and Commodity Supplemental Food
Programs, including aspects related to
the authorized foods and food packages;
and
• Consulting and collaborating with
NWA on a wide variety of WIC issues,
including those related to the WIC food
packages (1983-present). NWA is a nonprofit organization that was founded in
1983 by State and local agencies that
administer the WIC Program. In 2006,
NWA’s paid membership included 75 of
the 89 WIC State agencies, 675 local
agencies, 5 State WIC Associations, and
19 sustaining members (i.e., for-profit
and non-profit businesses or
organizations). Functioning as a
coalition of WIC agencies, NWA is
dedicated to maximizing WIC resources
through effective management practices.
NWA also serves in a leadership role for
WIC agencies by developing position
papers on issues of concern to the WIC
community.
Nature of Concerns and the Need To
Issue This Rule
• Congress has requested a WIC food
package rule that includes fruits and
vegetables and allows for cultural food
accommodations and responds to the
needs of the WIC population.
• The National Advisory Council on
Maternal, Infant, and Fetal Nutrition, in
its annual Reports to FNS, recommends
better accommodation of the nutritional
and cultural needs of WIC participants
through the WIC food packages; and
• In 1999, NWA (then the National
Association of WIC Directors (NAWD))
published a position paper entitled
‘‘NAWD WIC Food Prescription
Recommendations’’ and in 2003, NWA
published a position paper entitled
‘‘NWA WIC Culturally Sensitive Food
Prescription Recommendations.’’
NWA’s major recommendations in these
two reports were to reframe the WIC
food packages to be consistent with the
Dietary Guidelines for Americans and
allow State agencies flexibility to
accommodate cultural eating patterns.
Based upon the need to address the
nutritional needs of the WIC population
given current scientific information and
consumption patterns as exemplified by
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68983
the concerns and recommendations of
NWA, and others, FNS was aware of the
need to revise the WIC food packages.
Extent to Which We Meet Those
Concerns
FNS has considered the impact of the
interim rule on State and local agencies.
FNS believes that the rule is responsive
to the expressed concerns and requests
of commenters representing State and
local concerns. A few commenters
stated that the Department did not
conduct a regulatory risk assessment as
required for certain Departmental
regulations under section 304 of the
Federal Crop Insurance Reform and
Department of Agriculture
Reorganization Act of 1994, Public Law
103–354. However, based on the
statutory language and legislative intent,
the Department determined that a
regulatory risk assessment is not
required for this regulation.
Executive Order 12988
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. This rule is intended to have
preemptive effect with respect to any
State or local laws, regulations or
policies which conflict with its
provisions or which would otherwise
impede its full implementation. This
rule is not intended to have retroactive
effect unless so specified in the DATES
paragraph of the preamble of the interim
rule. Prior to any judicial challenge to
the provisions of this rule or the
application of its provisions, all
applicable administrative procedures
must be exhausted.
Civil Rights Impact Analysis
FNS has reviewed this interim rule in
accordance with FNS Regulation 4300–
4, ‘‘Civil Rights Impact Analysis,’’ to
identify and address any major civil
rights impacts the rule might have on
minorities, women, and persons with
disabilities. After a careful review of the
rule’s intent and provisions, and the
characteristics of WIC Program
applicants and participants, FNS has
determined that it does not have a
deleterious effect on the participation of
protected individuals in the WIC
Program. All data available to FNS
indicate that protected individuals have
the same opportunity to participate in
the WIC Program as non-protected
individuals. FNS specifically prohibits
State and local agencies operating the
WIC Program from discrimination based
on race, color, national origin, sex, age,
or disability. Section 246.8(a) of WIC
regulations requires State agencies to
ensure that no person will be excluded
from participation based on race, color,
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
national origin, age, sex or disability.
Where State agencies have options, and
they choose to implement a certain
provision, they must implement it in
such a way that it complies with the
regulations at 7 CFR 246.8.
This rule merely addresses revisions
to the WIC food packages to bring them
into line with the Dietary Guidelines for
Americans (1) and current infant feeding
recommendations from the American
Academy of Pediatrics. Several
provisions are specifically designed to
better accommodate WIC’s highly
diverse population. This interim rule
provides WIC State agencies with
greater flexibility in prescribing food
packages to accommodate participants
with cultural food preferences,
including allowing participants a broad
selection of fruits and vegetables; tofu
and soy-based beverage as substitutes
for milk; participant choice for whole
grains (including tortillas); and salmon
and sardines as substitutions for tuna.
This interim rule also makes provisions
to better accommodate the special
dietary needs of high-risk participants
served in Food Package III, helping to
protect the health and well-being of this
nutritionally vulnerable subset of WIC
participants.
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Paperwork Reduction Act
The Paperwork Reduction Act of 1995
(44 U.S.C. Chap. 35; see 5 CFR part
1320) requires that the Office of
Management and Budget (OMB)
approve all collections of information
by a Federal agency before they can be
implemented. In the publication of the
proposed rule on August 7, 2006, FNS
solicited comments on the burden
estimate; the need for the information;
its practical utility; ways to enhance its
quality, utility and clarity; and ways to
minimize the burden on respondents,
including the use of automated
collection techniques or other forms of
information technology. FNS received
no public comments in response to this
solicitation. On November 1, 2006, OMB
filed comment in accordance with 5
CFR 1320.11(c), requiring FNS to review
public comments in response to the
proposed rule and address any such
comments in the preamble of the final
rule. As a result, FNS has submitted a
new clearance package for OMB review
and approval. These information
collection requirements will not become
effective until approved by OMB. When
OMB has approved these information
collection requirements, FNS will
publish separate action in the Federal
Register.
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E-Government Act Compliance
The Food and Nutrition Service is
committed to complying with the EGovernment Act to promote the use of
the Internet and other information
technologies to provide increased
opportunities for citizen access to
Government information and services,
and for other purposes.
List of Subjects in 7 CFR Part 246
Administrative practice and
procedure, Civil rights, Food assistance
programs, Grant programs—health,
Grant programs—social programs,
Indians, Infants and children, Maternal
and child health, Nutrition, Penalties,
Reporting and recordkeeping
requirements, Women.
I For reasons set forth in the preamble,
7 CFR Part 246 is amended as follows:
PART 246—SPECIAL SUPPLEMENTAL
NUTRITION PROGRAM FOR WOMEN,
INFANTS AND CHILDREN
1. The authority citation for part 246
continues to read as follows:
I
Authority: 42 U.S.C. 1786.
2. In § 246.2:
a. Add new definitions of ‘‘Cash-value
voucher’’ and ‘‘Farmer’’ in alphabetical
order;
I b. Amend the definitions of
‘‘Compliance buy’’, ‘‘Employee fraud
and abuse’’, ‘‘Participants’’ and ‘‘Proxy’’
by removing the words ‘‘food
instruments’’ and adding in their place
the words ‘‘food instruments or cashvalue vouchers’’;
I c. Amend the definition ‘‘Nutrition
Services and Administration (NSA)
Costs’’ by removing the words ‘‘food
instruments’’ and adding in their place
the words ‘‘food instruments and cashvalue vouchers’’;
I d. Revise the definition of
‘‘Participant violation’’;
I e. Revise the definition of
‘‘Participation’’; and
I f. Amend the definition of ‘‘WICeligible medical foods’’ by removing the
words ‘‘with a diagnosed medical
condition’’ and adding in their place the
words ‘‘with a qualifying condition’’,
and by revising the second sentence.
The additions and revisions read as
follows:
I
I
§ 246.2
Definitions.
*
*
*
*
*
Cash-value voucher means a fixeddollar amount check, voucher,
electronic benefit transfer (EBT) card or
other document which is used by a
participant to obtain authorized fruits
and vegetables.
*
*
*
*
*
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Farmer means an individual
authorized by the State agency to sell
eligible fruits and vegetables to
participants at a farmers’ market or
roadside stands. Individuals who
exclusively sell produce grown by
someone else, such as wholesale
distributors, cannot be authorized.
*
*
*
*
*
Participant violation means any
intentional action of a participant,
parent or caretaker of an infant or child
participant, or proxy that violates
Federal or State statutes, regulations,
policies, or procedures governing the
Program. Participant violations include
intentionally making false or misleading
statements or intentionally
misrepresenting, concealing, or
withholding facts to obtain benefits;
exchanging cash-value vouchers, food
instruments or supplemental foods for
cash, credit, non-food items, or
unauthorized food items, including
supplemental foods in excess of those
listed on the participant’s food
instrument; threatening to harm or
physically harming clinic, farmer or
vendor staff; and dual participation.
Participation means the sum of:
(1) The number of persons who
received supplemental foods or food
instruments during the reporting period;
(2) The number of infants who did not
receive supplemental foods or food
instruments but whose breastfeeding
mother received supplemental foods or
food instruments during the report
period; and
(3) The number of breastfeeding
women who did not receive
supplemental foods or food instruments
but whose infant received supplemental
foods or food instruments during the
report period.
*
*
*
*
*
WIC-eligible medical foods * * *
Such WIC-eligible medical foods must
serve the purpose of a food, meal or diet
(may be nutritionally complete or
incomplete) and provide a source of
calories and one or more nutrients; be
designed for enteral digestion via an
oral or tube feeding; and may not be a
conventional food, drug, flavoring, or
enzyme.* * *
I 3. In § 246.4:
I a. Revise paragraph (a)(11)(iii).
I b. Amend paragraph (a)(14)(iii) by
revising the heading and the first
sentence;
I c. Revise paragraph (a)(14)(vi);
I d. Revise paragraph (a)(14)(xi);
I e. Amend paragraph (a)(14)(xii) by
removing the words ‘‘food instrument’’
wherever they appear and adding in
their place the words ‘‘food instrument
and cash-value voucher’’;
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f. Amend paragraph (a)(21) by
removing the words ‘‘food instruments’’
and adding in their place the words
‘‘food instruments and cash-value
vouchers’’; and
I g. Amend paragraph (a)(25)(iii) by
removing the words ‘‘food instruments’’
and adding in their place the words
‘‘food instruments, cash-value
vouchers’’.
The revisions read as follows:
I
§ 246.4
State plan.
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(a) * * *
(11) * * *
(iii) Instructions concerning all food
delivery operations performed at the
local level, including the list of
acceptable foods and their maximum
monthly quantities as required by
§ 246.10(b)(1).
*
*
*
*
*
(14) * * *
(iii) Vendor and farmer agreement. A
sample vendor and farmer, if applicable,
agreement, including the sanction
schedule, which may be incorporated as
an attachment or, if the sanction
schedule is in the State agency’s
regulations, through citation to the
regulations. * * *
*
*
*
*
*
(vi) Food instruments and cash-value
vouchers. A facsimile of the food
instrument and cash-value voucher, if
used, and a description of the system
the State agency will use to account for
the disposition of food instruments and
cash value vouchers in accordance with
§ 246.12(q);
*
*
*
*
*
(xi) Vendor and farmer training. The
procedures the State agency will use to
train vendors in accordance with
§ 246.12(i) and farmers. State agencies
that intend to delegate any aspect of
training to a local agency, contractor, or
vendor representative must describe the
State agency supervision and
instructions that will be provided to
ensure the uniformity and quality of
vendor training.
*
*
*
*
*
I 4. In § 246.7:
I a. Amend paragraphs (c)(2)(i) and
(f)(2)(i) by removing the words ‘‘food or
food instruments’’ and adding in their
place the words ‘‘ food, cash-value
vouchers or food instruments’’; and
I b. Revise paragraphs (f)(2)(iv),
(h)(3)(i), (j)(3) and (j)(6).
The revisions read as follows:
§ 246.7
Certification of participants.
*
*
*
*
*
(f) * * *
(2) * * *
(iv) Each local agency using a retail
purchase system shall issue a food
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instrument(s) and if applicable cashvalue voucher(s) to the participant at the
same time as notification of
certification. Such food instrument(s)
and cash-value vouchers shall provide
benefits for the current month or the
remaining portion thereof and shall be
redeemable immediately upon receipt
by the participant. Local agencies may
mail the initial food instrument(s) and
if applicable cash-value vouchers with
the notification of certification to those
participants who meet the criteria for
the receipt of food instruments through
the mail, as provided in § 246.12(r)(4).
*
*
*
*
*
(h) * * *
(3) * * *
(i) A State agency may allow local
agencies to disqualify a participant for
failure to obtain food instruments, cashvalue vouchers or supplemental foods
for several consecutive months. As
specified by the State agency, proof of
such failure includes failure to pick up
supplemental foods, cash-value
vouchers or food instruments,
nonreceipt of food instruments or cashvalue vouchers (when mailed
instruments or vouchers are returned),
or failure to have an electronic benefit
transfer card revalidated for purchase of
supplemental foods; or
*
*
*
*
*
(j) * * *
(3) If the State agency implements the
policy of disqualifying a participant for
not picking up supplemental foods,
cash-value vouchers or food instruments
in accordance with paragraph (h)(3)(i) of
this section, it shall provide notice of
this policy and of the importance of
regularly picking up cash-value
vouchers, food instruments or
supplemental foods to each participant,
parent or caretaker at the time of each
certification.
*
*
*
*
*
(6) A person who is about to be
suspended or disqualified from program
participation at any time during the
certification period shall be advised in
writing not less than 15 days before the
suspension or disqualification. Such
notification shall include the reasons for
this action, and the participant’s right to
a fair hearing. Further, such notification
need not be provided to persons who
will be disqualified for not picking up
cash-value vouchers, supplemental
foods or food instruments in accordance
with paragraph (h)(3)(i) of this section.
*
*
*
*
*
I 5. Revise § 246.10 to read as follows:
§ 246.10
Supplemental foods.
(a) General. This section prescribes
the requirements for providing
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68985
supplemental foods to participants. The
State agency must ensure that local
agencies comply with this section.
(b) State agency responsibilities. (1)
State agencies may:
(i) Establish criteria in addition to the
minimum Federal requirements in Table
4 of paragraph (e)(12) of this section,
except that the State agency may not
establish further restrictions on the
eligible fruits and vegetables, for the
supplemental foods in their States.
These State criteria could address, but
not be limited to, other nutritional
standards, competitive cost, State-wide
availability, and participant appeal; and
(ii) Make food package adjustments to
better accommodate participants who
are homeless. At the State agency’s
option, these adjustments would
include, but not be limited to, issuing
authorized supplemental foods in
individual serving-size containers to
accommodate lack of food storage or
preparation facilities.
(2) State agencies must:
(i) Identify the brands of foods and
package sizes that are acceptable for use
in the Program in their States in
accordance with the requirements of
this section. State agencies must also
provide to local agencies, and include in
the State Plan, a list of acceptable foods
and their maximum monthly allowances
as specified in Tables 1 through 4 of
paragraphs (e)(9) through (e)(12) of this
section; and
(ii) Ensure that local agencies:
(A) Make available to participants the
maximum monthly allowances of
authorized supplemental foods, except
as noted in paragraph (c) of this section,
and abide by the authorized substitution
rates for WIC food substitutions as
specified in Tables 1 through 3 of
paragraphs (e)(9) through (e)(11) of this
section;
(B) Make available to participants
more than one food from each WIC food
category except for the categories of
peanut butter and eggs, and any of the
WIC-eligible fruits and vegetables (fresh
or processed) in each authorized food
package as listed in paragraph (e) of this
section;
(C) Authorize only a competent
professional authority to prescribe the
categories of authorized supplemental
foods in quantities that do not exceed
the regulatory maximum and are
appropriate for the participant, taking
into consideration the participant’s age
and nutritional needs; and
(D) Advise participants or their
caretaker, when appropriate, that the
supplemental foods issued are only for
their personal use. However, the
supplemental foods are not authorized
for participant use while hospitalized
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on an in-patient basis. In addition,
consistent with § 246.7(m)(1)(i)(B),
supplemental foods are not authorized
for use in the preparation of meals
served in a communal food service. This
restriction does not preclude the
provision or use of supplemental foods
for individual participants in a
nonresidential setting (e.g., child care
facility, family day care home, school,
or other educational program); a
homeless facility that meets the
requirements of § 246.7(m)(1); or, at the
State agency’s discretion, a residential
institution (e.g., home for pregnant
teens, prison, or residential drug
treatment center) that meets the
requirements currently set forth in
§ 246.7(m)(1) and (m)(2).
(c) Nutrition tailoring. The full
maximum monthly allowances of all
supplemental foods in all food packages
must be made available to participants
if medically or nutritionally warranted.
Reductions in these amounts cannot be
made for cost-savings, administrative
convenience, caseload management, or
to control vendor abuse. Reductions in
these amounts cannot be made for
categories, groups or subgroups of WIC
participants. The provision of less than
the maximum monthly allowances of
supplemental foods to an individual
WIC participant in all food packages is
appropriate only when:
(1) Medically or nutritionally
warranted (e.g., to eliminate a food due
to a food allergy);
(2) A participant refuses or cannot use
the maximum monthly allowances; or
(3) The quantities necessary to
supplement another programs’
contribution to fill a medical
prescription would be less than the
maximum monthly allowances.
(d) Medical documentation—(1)
Supplemental foods requiring medical
documentation. Medical documentation
is required for the issuance of the
following supplemental foods:
(i) Any non-contract brand infant
formula;
(ii) Any infant formula prescribed to
a child or adult who receives Food
Package III;
(iii) Any exempt infant formula;
(iv) Any WIC-eligible medical food;
(v) Any authorized supplemental food
issued to participants who receive Food
Package III;
(vi) Any authorized soy-based
beverage or tofu issued to children who
receive Food Package IV;
(vii) Any additional authorized cheese
issued to children who receive Food
Package IV that exceeds the maximum
substitution rate;
(viii) Any additional authorized tofu
and cheese issued to women who
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receive Food Packages V and VII that
exceeds the maximum substitution rate;
and
(ix) Any contract brand infant formula
that does not meet the requirements in
Table 4 of paragraph (e)(12) of this
section.
(2) Supplemental foods not requiring
medical documentation. (i) State
agencies may authorize local agencies to
issue a non-contract brand infant
formula that meets the requirements in
Table 4 of paragraph (e)(12) of this
section without medical documentation
in order to meet religious eating
patterns; and
(ii) The State agency has the
discretion to require medical
documentation for any contract brand
infant formula and may decide that
some contract brand infant formula may
not be issued under any circumstances.
(3) Medical Determination. For
purposes of this program, medical
documentation means that a health care
professional licensed to write medical
prescriptions under State law has:
(i) Made a medical determination that
the participant has a qualifying
condition as described in paragraphs
(e)(3) through (e)(7) of this section that
dictates the use of the supplemental
foods, as described in paragraph (d)(1)
of this section; and
(ii) Provided the written
documentation that meets the technical
requirements described in paragraphs
(d)(4)(ii) and (d)(4)(iii) of this section.
(4) Technical Requirements—(i)
Location. All medical documentation
must be kept on file (electronic or hard
copy) at the local clinic. The medical
documentation kept on file must
include the initial telephone
documentation, when received as
described in paragraph (d)(4)(iii)(B) of
this section.
(ii) Content. All medical
documentation must include the
following:
(A) The name of the authorized WIC
formula (infant formula, exempt infant
formula, WIC-eligible medical food)
prescribed, including amount needed
per day;
(B) The authorized supplemental
food(s) appropriate for the qualifying
condition(s) and their prescribed
amounts;
(C) Length of time the prescribed WIC
formula and/or supplemental food is
required by the participant;
(D) The qualifying condition(s) for
issuance of the authorized supplemental
food(s) requiring medical
documentation, as described in
paragraphs (e)(3) through (e)(7) of this
section; and
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(E) Signature, date and contact
information (or name, date and contact
information), if the initial medical
documentation was received by
telephone and the signed document is
forthcoming, of the health care
professional licensed by the State to
write prescriptions in accordance with
State laws.
(iii) Written confirmation—(A)
General. Medical documentation must
be written and may be provided as an
original written document, an electronic
document, by facsimile or by telephone
to a competent professional authority
until written confirmation is received.
(B) Medical documentation provided
by telephone. Medical documentation
may be provided by telephone to a
competent professional authority who
must promptly document the
information. The collection of the
required information by telephone for
medical documentation purposes may
only be used until written confirmation
is received from a health care
professional licensed to write medical
prescriptions and used only when
absolutely necessary on an individual
participant basis. The local clinic must
obtain written confirmation of the
medical documentation within a
reasonable amount of time (i.e., one or
two week’s time) after accepting the
initial medical documentation by
telephone.
(5) Medical supervision requirements.
Due to the nature of the health
conditions of participants who are
issued supplemental foods that require
medical documentation, close medical
supervision is essential for each
participant’s dietary management. The
responsibility remains with the
participant’s health care provider for
this medical oversight and instruction.
This responsibility cannot be assumed
by personnel at the WIC State or local
agency. However, it would be the
responsibility of the WIC competent
professional authority to ensure that
only the amounts of supplemental foods
prescribed by the participant’s health
care provider are issued in the
participant’s food package.
(e) Food packages. There are seven
food packages available under the
Program that may be provided to
participants. The authorized
supplemental foods must be prescribed
from food packages according to the
category and nutritional needs of the
participant. The food packages are as
follows:
(1) Food Package I—Infants birth
through 5 months—(i) Participant
category served. This food package is
designed for issuance to infant
participants from birth through age 5
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months who do not have a condition
qualifying them to receive Food Package
III.
(ii) Infant feeding categories—(A)
Birth to one month. Three infant feeding
options are available during the first
month after birth—fully breastfeeding,
i.e., the infant receives no infant
formula from the WIC Program; partially
breastfeeding, i.e., the infant receives
not more than 104 reconstituted fluid
ounces of formula; or fully formulafeeding. Infant formula is not provided
during the first month after birth to fully
breastfed infants to support the
successful establishment of
breastfeeding.
(B) One through 5 months. Three
infant feeding options are available from
1 months through 5 months—fully
breastfeeding, fully formula-feeding, or
partially breastfeeding, i.e., the infant is
breastfed but also receives infant
formula from the WIC Program in an
amount not to exceed approximately
half the amount of infant formula
allowed for a fully formula fed infant.
(iii) Infant formula requirements. This
food package provides iron-fortified
infant formula that is not an exempt
infant formula. The issuance of any
contract brand or noncontract brand
infant formula that contains less than 10
milligrams of iron per liter at standard
dilution (i.e., approximately 20
kilocalories per fluid ounce of prepared
formula) is prohibited. Except as
specified in paragraph (d) of this
section, local agencies must issue a
contract brand infant formula that meets
the requirements in Table 4 of
paragraph (e)(12) of this section.
(iv) Physical forms. Local agencies
must issue all WIC formulas (WIC
formulas mean all infant formula,
exempt infant formula and WIC-eligible
medical foods) in concentrated liquid or
powder physical forms. Ready-to-feed
WIC formulas may be authorized when
the competent professional authority
determines and documents that:
(A) The participant’s household has
an unsanitary or restricted water supply
or poor refrigeration;
(B) The person caring for the
participant may have difficulty in
correctly diluting concentrated or
powder forms; or
(C) The WIC infant formula is only
available in ready-to-feed.
(v) Authorized category of
supplemental foods. Infant formula is
the only category of supplemental foods
authorized in this food package. Exempt
infant formulas and WIC-eligible
medical foods are authorized only in
Food Package III.
(2) Food Package II—Infants 6
through 11 months—(i) Participant
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Jkt 214001
category served. This food package is
designed for issuance to infant
participants from 6 through 11 months
of age who do not have a condition
qualifying them to receive Food Package
III.
(ii) Infant feeding options. Three
infant feeding options are available—
fully breastfeeding, fully formulafeeding, or partially breastfeeding.
(iii) Infant formula requirements. The
requirements for issuance of infant
formula in Food Package I, specified in
paragraphs (e)(1)(iii) and (e)(1)(iv) of
this section, also apply to the issuance
of infant formula in Food Package II.
(iv) Authorized categories of
supplemental foods. Infant formula,
infant fruits and vegetables, infant meat,
and infant cereal are the categories of
supplemental foods authorized in this
food package.
(3) Food Package III—Participants
with qualifying conditions—(i)
Participant category served and
qualifying conditions. This food package
is reserved for issuance to women,
infants and child participants who have
a documented qualifying condition that
requires the use of a WIC formula
(infant formula, exempt infant formula
or WIC-eligible medical food) because
the use of conventional foods is
precluded, restricted, or inadequate to
address their special nutritional needs.
Medical documentation must meet the
requirements described in paragraph (d)
of this section. Participants who are
eligible to receive this food package
must have one or more qualifying
conditions, as determined by a health
care professional licensed to write
medical prescriptions under State law.
The qualifying conditions include but
are not limited to premature birth, low
birth weight, failure to thrive, inborn
errors of metabolism and metabolic
disorders, gastrointestinal disorders,
malabsorption syndromes, immune
system disorders, severe food allergies
that require an elemental formula, and
life threatening disorders, diseases and
medical conditions that impair
ingestion, digestion, absorption or the
utilization of nutrients that could
adversely affect the participant’s
nutrition status. This food package may
not be issued solely for the purpose of
enhancing nutrient intake or managing
body weight.
(ii) Non-authorized issuance of Food
Package III. This food package is not
authorized for:
(A) Infants whose only condition is:
(1) A diagnosed formula intolerance
or food allergy to lactose, sucrose, milk
protein or soy protein that does not
require the use of an exempt infant
formula; or
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68987
(2) A non-specific formula or food
intolerance.
(B) Women and children who have a
food intolerance to lactose or milk
protein that can be successfully
managed with the use of one of the
other WIC food packages (i.e., Food
Packages IV–VII); or
(C) Any participant solely for the
purpose of enhancing nutrient intake or
managing body weight without an
underlying qualifying condition.
(iii) Restrictions on the issuance of
WIC formulas in ready-to-feed (RTF)
forms. WIC State agencies must issue
WIC formulas (infant formula, exempt
infant formula and WIC-eligible medical
foods) in concentrated liquid or powder
physical forms unless the requirements
for issuing RTF are met as described in
paragraph (e)(1)(iv) of this section. In
addition to those requirements, there are
two additional conditions which may be
used to issue RTF in Food Package III:
(A) If a ready-to-feed form better
accommodates the participant’s
condition; or
(B) If it improves the participant’s
compliance in consuming the
prescribed WIC formula.
(iv) Unauthorized WIC costs. All
apparatus or devices (e.g., enteral
feeding tubes, bags and pumps)
designed to administer WIC formulas
are not allowable WIC costs.
(v) Authorized categories of
supplemental foods. The supplemental
foods authorized in this food package
require medical documentation for
issuance and include infant formula (for
children or women), exempt infant
formula, WIC-eligible medical foods,
infant cereal, infant food fruits and
vegetables, milk and milk alternatives,
cheese, eggs, canned fish, fruits and
vegetables, breakfast cereal, whole
wheat bread or other whole grains,
juice, legumes and/or peanut butter.
(vi) Coordination with medical payors
and other programs that provide or
reimburse for formulas. WIC State
agencies must coordinate with other
Federal, State or local government
agencies or with private agencies that
operate programs that also provide or
could reimburse for exempt infant
formulas and WIC-eligible medical
foods benefits to mutual participants. At
a minimum, a WIC State agency must
coordinate with the State Medicaid
Program for the provision of exempt
infant formulas and WIC-eligible
medical foods that are authorized or
could be authorized under the State
Medicaid Program for reimbursement
and that are prescribed for WIC
participants who are also Medicaid
recipients. The WIC State agency is
responsible for providing up to the
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maximum amount of exempt infant
formulas and WIC-eligible medical
foods under Food Package III in
situations where reimbursement is not
provided by another entity.
(4) Food Package IV—Children 1
through 4 years—(i) Participant category
served. This food package is designed
for issuance to participants 1 through 4
years of age who do not have a
condition qualifying them to receive
Food Package III.
(ii) Authorized categories of
supplemental foods. Milk, breakfast
cereal, juice, fruits and vegetables,
whole wheat bread or other whole
grains, eggs, and legumes or peanut
butter are the categories of supplemental
foods authorized in this food package.
Cheese may be substituted for milk in
amounts described in Table 2 of
paragraph (e)(10) of this section.
Substitutions exceeding the maximum
substitution allowance of cheese, up to
the maximum allowance for fluid milk,
may be allowed with medical
documentation of the qualifying
condition. Soy-based beverage and tofu
can be substituted for milk only with
medical documentation in this food
package, in amounts described in Table
2 of paragraph (e)(10) of this section. A
health care professional licensed by the
State to write prescriptions must make
a medical determination and provide
medical documentation that a child
cannot drink milk and requires soybased beverage, tofu, or additional
cheese as a substitute for milk. Such
determination can be made for
situations that include, but are not
limited to, milk allergy, severe lactose
maldigestion, and vegan diets. Medical
documentation must meet the
requirements described in paragraph (d)
of this section.
(5) Food Package V—Pregnant and
partially breastfeeding women—(i)
Participant category served. This food
package is designed for issuance to
women participants with singleton
pregnancies who do not have a
condition qualifying them to receive
Food Package III. This food package is
also designed for issuance to
breastfeeding women participants, up to
1 year postpartum, who do not have a
condition qualifying them to receive
Food Package III and whose partially
breastfed infants receive formula from
the WIC program in amounts that do not
exceed the maximum allowances
described in Table 1 of paragraph (e)(9)
of this section. Women participants
breastfeeding more than one infant, and
women participants pregnant with more
than one fetus, are eligible to receive
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Food Package VII as described in
paragraph (e)(7) of this section.
(ii) Authorized categories of
supplemental foods. Milk, breakfast
cereal, juice, fruits and vegetables,
whole wheat bread or other whole
grains, eggs, legumes and peanut butter
are the categories of supplemental foods
authorized in this food package. Cheese
or calcium-set tofu may be substituted
for milk in amounts described in Table
2 of paragraph (e)(10) of this section.
Amounts of cheese or calcium-set tofu
exceeding the maximum substitution
allowances may be allowed with
medical documentation of the
qualifying condition, up to the
maximum allowance for fluid milk. A
health care professional licensed by the
State to write prescriptions must make
a medical determination and provide
medical documentation that a woman
cannot drink milk and requires
additional cheese or calcium-set tofu.
Such determination can be made for
situations that include, but are not
limited to, milk allergy or severe lactose
maldigestion. Medical documentation
must meet the requirements described
in paragraph (d) of this section.
(6) Food Package VI—Postpartum
women—(i) Participant category served.
This food package is designed for
issuance to women up to 6 months
postpartum who are not breastfeeding
their infants, and to breastfeeding
women up to 6 months postpartum
whose participating infant receives
more than the maximum amount of
formula allowed for partially breastfed
infants as described in Table 1 of
paragraph (e)(9) of this section.
(ii) Authorized categories of
supplemental foods. Milk, breakfast
cereal, juice, fruits and vegetables, eggs,
and legumes or peanut butter are the
categories of supplemental foods
authorized in this food package. Cheese
or calcium-set tofu may be substituted
for milk in amounts described in Table
2 of paragraph (e)(10) of this section.
Amounts of cheese or calcium-set tofu
exceeding the maximum substitution
allowances may be allowed with
medical documentation of the
qualifying condition, up to the
maximum allowance for fluid milk. A
health care professional licensed by the
State to write prescriptions must make
a medical determination and provide
medical documentation that a woman
cannot drink milk and requires
additional cheese or calcium-set tofu.
Such determination can be made for
situations that include, but are not
limited to, milk allergy or severe lactose
maldigestion. Medical documentation
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must meet the requirements described
in paragraph (d) of this section.
(7) Food Package VII—Fully
breastfeeding—(i) Participant category
served. This food package is designed
for issuance to breastfeeding women up
to 1 year postpartum whose infants do
not receive infant formula from WIC
(these breastfeeding women are
assumed to be fully breastfeeding their
infants). This food package is also
designed for issuance to women
participants pregnant with two or more
fetuses, and women participants
partially breastfeeding multiple infants.
Women participants fully breastfeeding
multiple infants receive 1.5 times the
supplemental foods provided in Food
Package VII.
(ii) Authorized categories of
supplemental foods. Milk, cheese,
breakfast cereal, juice, fruits and
vegetables, whole wheat bread or other
whole grains, eggs, legumes, peanut
butter, and canned fish are the
categories of supplemental foods
authorized in this food package. Cheese
or calcium-set tofu may be substituted
for milk in amounts described in Table
2 of paragraph (e)(10) of this section.
Amounts of cheese or calcium-set tofu
exceeding the maximum substitution
allowances may be allowed with
medical documentation of the
qualifying condition, up to the
maximum allowance for fluid milk. A
health care professional licensed by the
State to write prescriptions must make
a medical determination and provide
medical documentation that a woman
cannot drink milk and requires
additional cheese or calcium-set tofu.
Such determination can be made for
situations that include, but are not
limited to, milk allergy or severe lactose
maldigestion. Medical documentation
must meet the requirements described
in paragraph (d) of this section.
(8) Supplemental Foods—Maximum
monthly allowances, options and
substitution rates, and minimum
requirements. Tables 1 through 3 of
paragraphs (e)(9) through (e)(11) of this
section specify the maximum monthly
allowances of foods in WIC food
packages and identify WIC food options
and substitution rates. Table 4 of
paragraph (e)(12) of this section
describes the minimum requirements
and specifications of supplemental
foods in the WIC food packages.
(9) Maximum monthly allowances of
supplemental foods for infants. The
maximum monthly allowances, options
and substitution rates of supplemental
foods for infants in Food Packages I, II
and III are stated in Table 1 as follows:
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68989
TABLE 1.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR INFANTS IN FOOD PACKAGES I, II AND III
Fully formula fed (FF)
Food packages
I-FF & III-FF
A: 0 through 3
months
B: 4 through 5
months
Foods 1
Partially breastfed (BF/FF)
Food packages
II-FF & III-FF
6 through 11
months
WIC Formula 4 5 6 7 ..
A: 806 fl oz reconstituted liquid
concentrate or
832 fl oz RTF or
870 fl oz reconstituted powder.
B: 884 fl oz reconstituted liquid
concentrate or
896 fl oz RTF or
960 fl oz reconstituted powder.
624 fl oz reconstituted liquid concentrate or 640 fl
oz RTF or
696 fl oz reconstituted powder
Infant cereal 8 .........
Infant food fruits
and vegetables 8 9 10.
Infant food—
meat 8 10.
...............................
...............................
...............................
Food packages IBF/FF & III BF/FF
A: 0 to 1 month 2
B: 1 through 3
months 2
C: 4 through 5
months
Fully breastfed (BF)
Food packages
II-BF/FF &
III BF/FF
through 11 months
Food package
I-BF
0 through 5
months
Food package
II-BF
6 through 11
months
312 fl oz reconstituted liquid concentrate or 320 fl
oz RTF or
384 fl oz reconstituted powder
24 oz .....................
128 oz ...................
A: 104 fl oz reconstituted powder 3
B: 364 fl oz reconstituted liquid
concentrate or
384 fl oz RTF or
435 fl oz reconstituted powder
C: 442 fl oz reconstituted liquid
concentrate or
448 fl oz RTF or
522 fl oz reconstituted powder
...............................
...............................
24 oz .....................
128 oz ...................
...........................
...........................
24 oz.
256 oz.
...............................
...............................
...............................
...........................
77.5 oz.
Table 1 Footnotes: (abbreviations in order of appearance in table): FF = fully formula fed; BF/FF = partially breastfed (i.e., the infant is
breastfed but also receives formula from the WIC Program); 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 0 through 3 months in Food Package I.
3 Liquid concentrate and ready-to-feed (RTF) may be substituted at rates that provide comparable nutritive value.
4 WIC formula means infant formula, exempt infant formula, or WIC-eligible medical food. 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 Package III.
5 The maximum monthly allowance is specified in reconstituted fluid ounces for liquid concentrate, 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.
6 If powder infant formula is provided, State agencies must provide at least the number of reconstituted fluid ounces as the maximum allowance for the liquid concentrate form of the same product in the same Food Package up to the maximum monthly allowance for powder. State
agencies must issue whole containers that are all the same size.
7 State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the full authorized nutritional benefit (FNB). State agencies must use the methodology described in accordance with paragraph (h)(1) of
this section.
8 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.
9 Fresh banana may replace up to 16 ounces of infant food fruit at a rate of 1 pound of bananas per 8 ounces of infant food fruit.
10 In lieu of infant foods (cereal, fruit and vegetables, and meat), infants greater than 6 months of age in Food Package III may receive exempt
infant formula or WIC-eligible medical foods at the same maximum monthly allowance as infants ages 4 through 5 months of age of the same
feeding option.
(10) Maximum monthly allowances of
supplemental foods in Food Packages
IV through VII. The maximum monthly
allowances, options and substitution
rates of supplemental foods for children
and women in Food Package IV through
VII are stated in Table 2 as follows:
TABLE 2.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGES
IV, V, VI AND VII
Children
Women
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Foods 1
Food package IV
1 through 4 years
Food package V: Pregnant
and partially breastfeeding
(up to 1 year postpartum) 2
Food package VI:
Postpartum (up to 6
months postpartum) 3
Juice, single strength 6 ......
Milk, fluid ...........................
Breakfast cereal 13 .............
Cheese ..............................
Eggs ..................................
Fruits and vegetables 14 15
128 fl oz ............................
16 qt 7 8 9 10 .........................
36 oz .................................
N/A ....................................
1 dozen .............................
$6.00 in cash value vouchers.
2 lb ....................................
144 fl oz ............................
22 qt. 7 8 11 12 ......................
36 oz .................................
N/A ....................................
1 dozen .............................
$8.00 in cash-value vouchers.
1 lb ....................................
96 fl oz ..............................
16 qt. 7 8 11 12 ......................
36 oz .................................
N/A ....................................
1 dozen .............................
$8.00 in cash-value vouchers.
N/A ....................................
144 fl oz.
24 qt. 7 8 11 12
36 oz.
1 lb.
2 dozen.
$10.00 in cash-value
vouchers.
1 lb.
N/A ....................................
N/A ....................................
N/A ....................................
30 oz.
Whole wheat bread or
other whole grains 16.
Fish (canned) ....................
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TABLE 2.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGES
IV, V, VI AND VII—Continued
Children
Women
Foods 1
Food package IV
1 through 4 years
Food package V: Pregnant
and partially breastfeeding
(up to 1 year postpartum) 2
Food package VI:
Postpartum (up to 6
months postpartum) 3
Legumes, dry 17 .................
And/or peanut butter .........
1 lb ....................................
Or 18 oz ............................
1 lb ....................................
And 18 oz ..........................
1 lb ....................................
Or 18 oz ............................
Food package VII: Fully
breastfeeding (up to 1 year
post-partum) 4 5
1 lb.
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, I-BF/FF-C, 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 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, IBF/FF-C 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 Food Package VII is issued to three categories of WIC participants: Fully breastfeeding women whose infants do not receive formula from the
WIC Program; 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 monthly 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 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.
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 qualifying 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 beverage 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 1 pound of cheese per 3 quarts of milk or 1 pound of tofu
per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in this manner in Food Packages V and VI; however, no more than 1
pound of cheese may be substituted for milk. A maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore,
no more than 2 lbs. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese or tofu may be substituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other qualifying conditions.
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 At least one-half of the total number of breakfast cereals on the State agency’s authorized food list must have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat content’’ as defined in Table 4 of
paragraph (e)(12) of this section.
14 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.
15 The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as described in § 246.16(j).
16 Brown rice, bulgur (cracked wheat), oatmeal, whole-grain barley, soft corn or whole wheat tortillas may be substituted for whole wheat bread
on an equal weight basis.
17 Canned legumes may be substituted for dried legumes at the rate of 64 oz. of canned beans for 1 lb. dried beans. Under Food Packages V
and VII, two additional combinations of dry or canned beans/peas are authorized: 1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry or 128 oz. Canned beans/peas (and no peanut butter) or 36 oz. peanut butter (and no beans).
(11) Maximum monthly allowances of
supplemental foods for children and
women with qualifying conditions in
Food Package III. The maximum
monthly allowances, options and
substitution rates of supplemental foods
for participants with qualifying
conditions in Food Package III are stated
in Table 3 as follows:
TABLE 3.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGE
III
Children
Women
Foods1
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1 through 4 years
Juice, single
strength 6.
WIC Formula 7 8 .....
Milk .........................
Breakfast cereal 15 16.
Cheese ..................
Eggs .......................
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Pregnant and partially
breastfeeding (up to 1 year
postpartum) 2
Postpartum (up to 6 months
postpartum) 3
Fully breastfeeding, (up to 1
year post-partum) 4 5
128 fl oz ...............................
144 fl oz ...............................
96 fl oz .................................
144 fl oz.
455 fl oz liquid concentrate
16 qt 9 10 11 12 ........................
36 oz ....................................
455 fl oz liquid concentrate
22 qt 9 10 13 14 ........................
36 oz ....................................
455 fl oz liquid concentrate
16 qt 9 10 13 14 ........................
36 oz ....................................
455 fl oz. liquid concentrate.
24 qt. 9 10 13 14
36 oz.
N/A .......................................
1 dozen ................................
N/A .......................................
1 dozen ................................
N/A .......................................
1 dozen ................................
1 lb.
2 dozen.
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TABLE 3.—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGE
III—Continued
Children
Women
Foods1
1 through 4 years
Fruits and vegetables 17 18.
Whole wheat
bread 19.
Fish (canned) .........
Legumes, dry 20 .....
and/or Peanut butter.
Pregnant and partially
breastfeeding (up to 1 year
postpartum) 2
Postpartum (up to 6 months
postpartum) 3
Fully breastfeeding, (up to 1
year post-partum) 4 5
$6.00 in cash value vouchers.
2 lb .......................................
$8.00 in cash value vouchers.
1 lb .......................................
$8.00 in cash value vouchers.
N/A .......................................
$10.00 in cash value vouchers.
1 lb.
N/A .......................................
1 lb .......................................
Or 18 oz ...............................
N/A .......................................
1 lb .......................................
And 18 oz ............................
N/A .......................................
1 lb .......................................
Or 18 oz ...............................
30 oz.
1 lb.
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 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, I–BF/FF–C, 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 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 formula allowances for Food Packages I–BF/FF–A, I–BF/FF–B, I–BF/
FF–C 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 Food Package VII is issued to three categories of WIC participants—fully breastfeeding women whose infants do not receive formula from the
WIC Program; 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 monthly 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, 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. With medical
documentation, whole milk may be substituted for reduced fat milk 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 qualifying conditions, up to the maximum allowance for fluid milk.
12 For children, soy-based beverage and tofu may be substituted for milk only with medical documentation for qualifying conditions. Soy-based
beverage 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 substituted, 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 At least one half of the total number of breakfast cereals on the State agency’s authorized food list must have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat content’’ as defined in Table 4 of
paragraph (e)(12) of this section.
17 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.
18 The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as described in § 246.16(j).
19 Brown rice, bulgur (cracked wheat), oatmeal, whole-grain barley, soft corn or whole wheat tortillas may be substituted for whole wheat bread
on an equal weight basis.
20 Canned legumes may be substituted for dried legumes at the rate of 64 oz of canned beans for 1 lb dried beans. Issuance of two additional
combinations of dry or canned beans/peas is authorized for the Pregnant and Partially Breastfeeding (up to 1 year postpartum) category and
Fully Breastfeeding (Enhanced) (up to 1 year postpartum) category: 1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry
or 128 oz. Canned beans/peas (and no peanut butter) or 36 oz. Peanut butter (and no beans).
(12) Minimum requirements and
specifications for supplemental foods.
Table 4 describes the minimum
requirements and specifications for
supplemental foods in all food
packages:
TABLE 4.—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS
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Categories/foods
Minimum requirements and specifications
WIC formula:
Infant formula ...............................................
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All authorized infant formulas must (1) meet the definition for an infant formula in section
201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and meet the requirements for an infant formula under section 412 of the Federal Food, Drug and Cosmetic
Act, as amended (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107;
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TABLE 4.—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS—Continued
Categories/foods
Minimum requirements and specifications
Exempt infant formula .................................
WIC-eligible medical foods.1
Milk and milk alternatives:
Cow’s milk ...................................................
Goat milk .....................................................
Cheese ........................................................
Tofu ..............................................................
Soy-based beverage ...................................
Juice ....................................................................
Eggs ....................................................................
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Breakfast cereal ..................................................
Fruits and Vegetables (fresh and processed) ....
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(2) Be designed for enteral digestion via an oral or tube feeding;
(3) Provide at least 10 mg iron per liter (at least 1.8 mg iron/100 kilocalories) at standard dilution;
(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.
All authorized exempt infant formula must (1) meet the definition and requirements for an exempt infant formula under section 412(h) of the Federal Food, Drug, and Cosmetic Act as
amended (21 U.S.C. 350a(h)) and the regulations at 21 CFR Parts 106 and 107; and
2) Be designed for enteral digestion via an oral or tube feeding.
Certain enteral products that are specifically formulated to provide nutritional support for individuals with a qualifying condition, when the use of conventional foods is precluded, restricted, or inadequate. Such WIC-eligible medical foods must serve the purpose of a food,
meal or diet (may be nutritionally complete or incomplete) and provide a source of calories
and one or more nutrients; be designed for enteral digestion via an oral or tube feeding; and
may not be a conventional food, drug, flavoring, or enzyme.
WIC-eligible medical foods include many, but not all, products that meet the definition of medical food in Section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)).
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).
Must conform to FDA standard of identity for whole, reduced fat, low-fat, or non-fat milks (21
CFR part 131). 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 part 131). May be flavored or unflavored. May be fluid, shelf-stable,
evaporated (21 CFR 131.130), or dried (i.e., powdered) (21 CFR 131.147).2
Domestic cheese made from 100 percent pasteurized milk. Must conform to FDA standard of
identity (21 CFR Part 133); Monterey Jack, Colby, natural Cheddar, Swiss, Brick, Muenster,
Provolone, part-skim or whole Mozzarella, pasteurized processed American, or blends of
any of these cheeses are authorized.
Cheeses that are labeled low, free, reduced, less or light in the nutrients of sodium, fat or cholesterol are WIC-eligible.3
Calcium-set tofu prepared with only calcium salts (e.g., calcium sulfate). May not contain
added fats, sugars, oils, or sodium.
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
mg phosphorus per cup, 349 mg potassium per cup, 0.44 mg riboflavin per cup, and 1.1
mcg vitamin B12 per cup, in accordance with fortification guidelines issued by FDA.
Must be pasteurized 100% unsweetened fruit juice. Must conform to FDA standard of identity
(21 CFR part 146) or vegetable juice must conform to FDA standard of identity (21 CFR part
156) and contain at least 30 mg of vitamin C per 100 mL of juice. With the exception of 100
percent citrus juices, State agencies must verify the vitamin C content of all State-approved
juices. Juices that are fortified with other nutrients may be allowed at the State agency’s option. Juice may be fresh, from concentrate, frozen, canned, or shelf-stable.
Vegetable juice may be regular or lower in sodium.3
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.
Breakfast cereals as defined by FDA in 21 CFR 170.3(n)(4) for ready-to-eat and instant and
regular hot cereals.
Must contain a minimum of 28 mg iron per 100 g dry cereal.
Must contain ≤ 21.2 g sucrose and other sugars per 100 g dry cereal (≤ 6 g per dry oz).
At least half of the cereals authorized on a State agency’s food list must have whole grain as
the primary ingredient by weight AND 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.
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
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TABLE 4.—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS—Continued
Categories/foods
Minimum requirements and specifications
Whole wheat bread/Whole grain bread/Other
whole unprocessed grains.
Canned fish 6 ......................................................
Mature legumes (dry beans and peas) ..............
Peanut butter ......................................................
Infant Foods:
Infant cereal .................................................
Infant fruits ...................................................
Infant vegetables .........................................
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Infant meat ...................................................
Any variety of canned 6 fruits (must conform to FDA standard of identity (21 CFR part 145); including applesauce, juice pack or water pack without added sugars, fats, oils, or salt (i.e. sodium). Any variety of frozen fruits without added sugars.7
Any variety of canned 6 or frozen vegetables (must conform to FDA standard of identity (21
CFR part 155)) except white potatoes (orange yams and sweet potatoes are allowed); without added sugars, fats, or oils. May be regular or lower in sodium.3 thnsp;7
Any type of dried fruits or dried vegetable without added sugars, fats, oils, or salt (i.e., sodium).5
Bread
Whole wheat bread must conform to FDA standard of identity (21 CFR 136.180). (Includes
whole wheat buns and rolls.)
AND
Whole wheat must be the primary ingredient by weight in all whole wheat bread products.
Whole grain bread must 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.
AND
Whole grain must be the primary ingredient by weight in all whole grain bread products.
Other Whole Unprocessed Grains
Brown rice, bulgur (cracked wheat), oatmeal, and 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 may be allowed at the State agency’s option. Whole grain
must be the primary ingredient by weight.
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;
Mackerel (N. Atlantic Scomber scombrus, or Chub Pacific Scomber japonicus);
May be packed in water or oil. Pack may include bones or skin. May be regular or lower in sodium content.3
Any type of mature dry beans, peas, or lentils in dry-packaged or canned 6 forms. Examples
include but are not limited to black beans (‘‘turtle beans’’), blackeye peas (cowpeas of the
blackeye variety, ‘‘cow beans’’), garbanzo beans (chickpeas), great northern beans, kidney
beans, lima beans (‘‘butter beans’’), navy beans, pinto beans, soybeans, split peas, and lentils. All categories exclude soups. May not contain added sugars, fats, oils or meat as purchased. Canned legumes may be regular or lower in sodium content.3 thnsp;8
Baked beans may be provided for participants with limited cooking facilities.8
Peanut butter and reduced fat peanut butter (must conform to FDA Standard of Identity (21
CFR 164.150)); creamy or chunky, regular or reduced fat, salted or unsalted 3 forms are allowed.
Infant cereal must contain a minimum of 45 mg of iron per 100 g of dry cereal.9
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
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
Any variety of commercial infant food meat or poultry, as a single major ingredient, with added
broth or gravy. Added sugars or salt (i.e. sodium) are not allowed. 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 rehydration fluids or electrolyte solutions; flavoring or thickening agents; and feeding utensils or devices (e.g., feeding tubes, bags, pumps) designed to
administer a WIC-eligible formula.
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 lactosefree, acidified, and UHT pasteurized milks. Other milks are permitted at the State agency’s discretion provided that the State agency determines
that the milk meets the minimum requirements for authorized milk.
3 Any of the folowing lower sodium forms are allowable:
Sodium-free—less than 5 mg sodium per serving;
Very low sodium—35 mg sodium or less per serving or, if the serving is 30 g or less or 2 tablespoons or less, 35 mg sodium or less per 50 g
of the food;
Low-sodium—140 mg sodium or less per serving or, if the serving is 30 g or less or 2 tablespoons or less, 140 mg sodium or less per 50 g of
the food;
Light in sodium—at least 50 percent less sodium per serving than average reference amount for same food with no sodium reduction;
Lightly salted—at least 50 percent less sodium per serving than reference amount (If the food is not ‘‘low in sodium,’’ the statement ‘‘not a lowsodium food’’ must appear on the same panel as the Nutrition Facts panel.); and
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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 https://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 trays; 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.
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.
12 No infant food combinations (e.g., meat and vegetables) or dinners (e.g., spaghetti and meatballs) are allowed.
(f) USDA purchase of commodity
foods. (1) At the request of a State
agency, FNS may purchase commodity
foods for the State agency using funds
allocated to the State agency. The
commodity foods purchased and made
available to the State agency must be
equivalent to the foods specified in
Table 4 of paragraph (e)(12) of this
section.
(2) The State agency must:
(i) Distribute the commodity foods to
its local agencies or participants; and
(ii) Ensure satisfactory storage
facilities and conditions for the
commodity foods, including
documentation of proper insurance.
(g) Infant formula manufacturer
registration. Infant formula
manufacturers supplying formula to the
WIC Program must be registered with
the Secretary of Health and Human
Services under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et
seq.). Such manufacturers wishing to
bid for a State contract to supply infant
formula to the program must certify
with the State health department that
their formulas comply with the Federal
Food, Drug, and Cosmetic Act and
regulations issued pursuant to the Act.
(h) Rounding up. State agencies may
round up to the next whole container
for either infant formula or infant foods
(infant cereal, fruits, vegetables and
meat). State agencies that use the
rounding up option must calculate the
amount of infant formula or infant foods
provided according to the requirements
and methodology as described in this
section.
(1) Infant Formula. State agencies
must use the maximum monthly
allowance of reconstituted fluid ounces
of liquid concentrate infant formula as
specified in Table 1 of paragraph (e)(9)
of this section as the full nutritional
benefit (FNB) provided by infant
formula for each food package category
and infant feeding option (e.g., Food
Package I A fully formula fed, IA–FF).
(i) For State agencies that use
rounding up of infant formula, the FNB
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is determined over the timeframe (the
number of months) that the participant
receives the food package. In any given
month of the timeframe, the monthly
issuance of reconstituted fluid ounces of
infant formula may exceed the
maximum monthly allowance or fall
below the FNB; however, the
cumulative average over the timeframe
may not fall below the FNB. In addition,
the State agency must:
(A) Use the methodology described in
paragraph (h)(1)(ii) of this section for
calculating and dispersing the rounding
up option;
(B) Issue infant formula in whole
containers that are all the same size; and
(C) Disperse the number of whole
containers as evenly as possible over the
timeframe with the largest monthly
issuances given in the beginning of the
timeframe.
(ii) The methodology to calculate
rounding up and dispersing infant
formula to the next whole container
over the food package timeframe is as
follows:
(A) Multiply the FNB amount for the
appropriate food package and feeding
option (e.g. Food Package I A fully
formula fed, IA–FF) by the timeframe
the participant will receive the food
package to determine the total amount
of infant formula to be provided.
(B) Divide the total amount of infant
formula to be provided by the yield of
the container (in reconstituted fluid
ounces) issued by the State agency to
determine the total number of
containers to be issued during the
timeframe that the food package is
prescribed.
(C) If the number of containers to be
issued does not result in a whole
number of containers, the State agency
must round up to the next whole
container in order to issue whole
containers.
(2) Infant foods. (i) State agencies may
use the rounding up option to the next
whole container of infant food (infant
cereal, fruits, vegetables and meats)
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when the maximum monthly allowance
cannot be issued due to varying
container sizes of authorized infant
foods.
(ii) State agencies that use the
rounding up option for infant foods
must:
(A) Use the methodology described in
paragraph (h)(2)(iii) of this section for
calculating and dispersing the rounding
up option;
(B) Issue infant foods in whole
containers; and
(C) Disperse the number of whole
containers as evenly as possible over the
timeframe (the number of months the
participant will receive the food
package).
(iii) The methodology to round up
and disperse infant food is as follows:
(A) Multiply the maximum monthly
allowance for the infant food by the
timeframe the participant will receive
the food package to determine the total
amount of food to be provided.
(B) Divide the total amount of food
provided by the container size issued by
the State agency (e.g., ounces) to
determine the total number of food
containers to be issued during the
timeframe that the food package is
prescribed.
(C) If the number of containers to be
issued does not result in a whole
number of containers, the State agency
must round up to the next whole
container in order to issue whole
containers.
(i) Plans for substitutions. (1) The
State agency may submit to FNS a plan
for substitution of food(s) acceptable for
use in the Program to allow for different
cultural eating patterns. The plan shall
provide the State agency’s justification,
including a specific explanation of the
cultural eating pattern and other
information necessary for FNS to
evaluate the plan as specified in
paragraph (i)(2) of this section.
(2) FNS will evaluate a State agency’s
plan for substitution of foods for
different cultural eating patterns based
on the following criteria:
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(i) Any proposed substitute food must
be nutritionally equivalent or superior
to the food it is intended to replace.
(ii) The proposed substitute food must
be widely available to participants in
the areas where the substitute is
intended to be used.
(iii) The cost of the substitute food
must be equivalent to or less than the
cost of the food it is intended to replace.
(3) FNS will make a determination on
the proposed plan based on the
evaluation criteria specified in
paragraph (i)(2) of this section, as
appropriate. The State agency shall
substitute foods only after receiving the
written approval of FNS.
I 6. In § 246.12:
I a. Revise the second sentence of
paragraph (a)(1).
I b. Amend paragraphs (e), (f)(2)(i),
(f)(2)(ii), (f)(2)(iv), (h)(3)(ix), (k)(2), and
(k)(3), by removing the words ‘‘food
instrument’’ wherever they appear and
adding in their place the words ‘‘food
instrument or cash-value voucher’’;
I c. Amend paragraphs (h)(3)(i),
(h)(3)(xv), and (i)(2), by removing the
words ‘‘food instruments’’ wherever
they appear and adding in their place
the words ‘‘food instruments and cashvalue vouchers’’;
I d. Amend paragraphs (l)(1)(i),
(l)(1)(ii)(B), (l)(1)(iii)(A), (l)(1)(iii)(D),
and (l)(1)(iii)(F), by removing the words
‘‘food instruments’’ wherever they
appear and adding in their place the
words ‘‘food instruments or cash-value
vouchers’’;
I e. Revise the heading of paragraph (f),
paragraph (f)(1), paragraph (f)(2)
introductory text, paragraphs (f)(2)(iii),
(f)(3), (g)(3)(i), (h)(3)(ii), and (h)(3)(iv)
through (h)(3)(vi), (h)(3)(x), and
paragraphs (k)(1), (k)(5), and (o) through
(s);
I f. Amend paragraph (t) by removing
the word ‘‘vendor’’ and adding in its
place the words ‘‘vendor, farmer’’; and
I g. Add a new paragraph (v).
The addition and revisions read as
follows:
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§ 246.12
Food delivery systems.
(a) * * *
(1) * * * The State agency may
permit only authorized vendors and
farmers, home food delivery contractors,
and direct distribution sites to accept
food instruments and cash-value
vouchers.
*
*
*
*
*
(f) Retail food delivery systems: Food
instrument and cash-value voucher
requirements—(1) General. State
agencies using retail food delivery
systems must use food instruments and
cash-value vouchers that comply with
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the requirements of paragraph (f)(2) of
this section.
(2) Printed food instruments and
cash-value vouchers. Each printed food
instrument and cash-value voucher
must clearly bear on its face the
following information:
*
*
*
*
*
(iii) Last date of use. The last date on
which the food instrument or cash-value
vouchers may be used to obtain
authorized supplemental foods. This
date must be a minimum of 30 days
from the first date on which it may be
used, except for the participant’s first
month of issuance, when it may be the
end of the month or cycle for which the
food instrument or cash-value voucher
is valid. Rather than entering a specific
last date of use on each instrument or
cash-value voucher, all instruments or
cash-value vouchers may be printed
with a notice that the participant must
transact them within a specified number
of days after the first date on which the
food instrument or cash-value voucher
may be used;
*
*
*
*
*
(3) Vendor identification. The State
agency must implement procedures to
ensure each food instrument and cashvalue voucher submitted for redemption
can be identified by the vendor or
farmer that submitted the food
instrument or cash-value voucher. Each
vendor operated by a single business
entity must be identified separately. The
State agency may identify vendors by
requiring that all authorized vendors
stamp their names and/or enter a vendor
identification number on all food
instruments or cash-value vouchers
prior to submitting them for
redemption.
(g) * * *
(3) * * *
(i) Minimum variety and quantity of
supplemental foods. The State agency
must establish minimum requirements
for the variety and quantity of
supplemental foods that a vendor
applicant must stock to be authorized.
These requirements include that the
vendor stock at least two varieties of
fruits, two varieties of vegetables, and at
least one whole grain cereal authorized
by the State agency. The State agency
may not authorize a vendor applicant
unless it determines that the vendor
applicant meets these minimums. The
State agency may establish different
minimums for different vendor peer
groups.
*
*
*
*
*
(h) * * *
(3) * * *
(ii) No substitutions, cash, credit,
refunds, or exchanges. The vendor may
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provide only the authorized
supplemental foods listed on the food
instrument and cash-value voucher. The
vendor may not provide unauthorized
food items, non-food items, cash, or
credit (including rainchecks) in
exchange for food instruments or cashvalue vouchers. The vendor may not
provide refunds or permit exchanges for
authorized supplemental foods obtained
with food instruments or cash-value
vouchers, except for exchanges of an
identical authorized supplemental food
item when the original authorized
supplemental food item is defective,
spoiled, or has exceeded its ‘‘sell by,’’
‘‘best if used by,’’ or other date limiting
the sale or use of the food item. An
identical authorized supplemental food
item means the exact brand and size as
the original authorized supplemental
food item obtained and returned by the
participant.
*
*
*
*
*
(iv) Time periods for transacting food
instruments and cash-value vouchers.
The vendor may accept a food
instrument or cash-value voucher only
within the specified time period.
(v) Purchase price on food
instruments and cash-value vouchers.
The vendor must ensure that the
purchase price is entered on food
instruments and cash-value vouchers in
accordance with the procedures
described in the vendor agreement. The
State agency has the discretion to
determine whether the vendor or the
participant enters the purchase price.
The purchase price must include only
the authorized supplemental food items
actually provided and must be entered
on the food instrument or cash-value
voucher before it is signed.
(vi) Signature on food instruments
and cash-value vouchers. For printed
food instruments and cash-value
vouchers, the vendor must ensure the
participant, parent or caretaker of an
infant or child participant, or proxy
signs the food instrument or cash-value
voucher in the presence of the cashier.
In EBT systems, a Personal
Identification Number (PIN) may be
used in lieu of a signature.
*
*
*
*
*
(x) No charge for authorized
supplemental foods or restitution from
participants. The vendor may not charge
participants, parents or caretakers of
infant and child participants, or proxies
for authorized supplemental foods
obtained with food instruments or cashvalue vouchers. In addition, the vendor
may not seek restitution from these
individuals for food instruments or
cash-value vouchers not paid or
partially paid by the State agency. The
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State agency may, however, allow
participants, parents or caretakers of
child participants to pay the difference
when the purchase of authorized fruits
and vegetables exceeds the value of the
cash-value voucher.
*
*
*
*
*
(k) * * *
(1) System to review food instruments
and cash-value vouchers for vendor
claims. The State agency must design
and implement a system to review food
instruments and cash-value vouchers
submitted by vendors for redemption to
ensure compliance with the applicable
price limitations and to detect
questionable food instruments or cashvalue vouchers, suspected vendor
overcharges, and other errors. This
review must examine either all or a
representative sample of the food
instruments and cash-value vouchers
and may be done either before or after
the State agency makes payments on the
food instruments or cash-value
vouchers. The review of food
instruments must include a price
comparison or other edit designed to
ensure compliance with the applicable
price limitations and to assist in
detecting vendor overcharges. For
printed food instruments and cash-value
vouchers the system also must detect
the following errors—purchase price
missing; participant, parent/caretaker,
or proxy signature missing; vendor
identification missing; food instruments
or cash-value vouchers transacted or
redeemed after the specified time
periods; and, as appropriate, altered
purchase price. The State agency must
take follow-up action within 120 days of
detecting any questionable food
instruments or cash-value vouchers,
suspected vendor overcharges, and
other errors and must implement
procedures to reduce the number of
errors when possible.
*
*
*
*
*
(5) Food instruments and cash-value
vouchers redeemed after the specified
period. With justification and
documentation, the State agency may
pay vendors for food instruments and
cash-value vouchers submitted for
redemption after the specified period for
redemption. If the total value of such
food instruments or cash-value vouchers
submitted at one time exceeds $500.00,
the State agency must obtain the
approval of the FNS Regional Office
before payment.
*
*
*
*
*
(o) Participant, parent/caretaker,
proxy, vendor, farmer and home food
delivery contractor complaints. The
State agency must have procedures to
document the handling of complaints by
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participants, parents or caretakers of
infant or child participants, proxies,
vendors, farmers, home food delivery
contractors, and direct distribution
contractors. Complaints of civil rights
discrimination must be handled in
accordance with § 246.8(b).
(p) Food instrument and cash-value
voucher security. The State agency must
develop standards for ensuring the
security of food instruments and cashvalue vouchers from the time the food
instruments and cash-value vouchers
are created to the time they are issued
to participants, parents/caretakers, or
proxies. For pre-printed food
instruments or cash-value vouchers,
these standards must include
maintenance of perpetual inventory
records of food instruments or cashvalue vouchers throughout the State
agency’s jurisdiction; monthly physical
inventory of food instruments or cashvalue vouchers on hand throughout the
State agency’s jurisdiction;
reconciliation of perpetual and physical
inventories of food instruments and
cash-value vouchers; and maintenance
of all food instruments and cash-value
vouchers under lock and key, except for
supplies needed for immediate use. For
EBT and print-on-demand food
instruments and cash-value vouchers,
the standards must provide for the
accountability and security of the means
to manufacture and issue such food
instruments and cash-value vouchers.
(q) Food instrument and cash-value
voucher disposition. The State agency
must account for the disposition of all
food instruments and cash-value
vouchers as either issued or voided, and
as either redeemed or unredeemed.
Redeemed food instruments and cashvalue vouchers must be identified as
validly issued, lost, stolen, expired,
duplicate, or not matching valid
enrollment and issuance records. In an
EBT system, evidence of matching
redeemed food instruments to valid
enrollment and issuance records may be
satisfied through the linking of the
Primary Account Number (PAN)
associated with the electronic
transaction to valid enrollment and
issuance records. This process must be
performed within 120 days of the first
valid date for participant use of the food
instruments and must be conducted in
accordance with the financial
management requirements of § 246.13.
The State agency will be subject to
claims as outlined in § 246.23(a)(4) for
redeemed food instruments or cashvalue vouchers that do not meet the
conditions established in paragraph (q)
of this section.
(r) Issuance of food instruments, cashvalue vouchers and authorized
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supplemental foods. The State agency
must:
(1) Parents/caretakers and proxies.
Establish uniform procedures that allow
parents and caretakers of infant and
child participants and proxies to obtain
and transact food instruments and cashvalue vouchers or obtain authorized
supplemental foods on behalf of a
participant. In determining whether a
particular participant or parent/
caretaker should be allowed to designate
a proxy or proxies, the State agency
must require the local agency or clinic
to consider whether adequate measures
can be implemented to provide
nutrition education and health care
referrals to that participant or, in the
case of an infant or child participant, to
the participant’s parent or caretaker;
(2) Signature requirement. Ensure that
the participant, parent or caretaker of an
infant or child participant, or proxy
signs for receipt of food instruments,
cash-value vouchers or authorized
supplemental foods, except as provided
in paragraph (r)(4) of this section;
(3) Instructions. Ensure that
participants, parents or caretakers of
infant and child participants, and
proxies receive instructions on the
proper use of food instruments and
cash-value vouchers, or on the
procedures for obtaining authorized
supplemental foods when food
instruments or cash-value vouchers are
not used. The State agency must also
ensure that participants, parents or
caretakers of infant and child
participants, and proxies are notified
that they have the right to complain
about improper vendor, farmer and
home food delivery contractor practices
with regard to program responsibilities;
(4) Food instrument and cash-value
voucher pick up. Require participants,
parents and caretakers of infant and
child participants, and proxies to pick
up food instruments and cash-value
vouchers in person when scheduled for
nutrition education or for an
appointment to determine whether
participants are eligible for a second or
subsequent certification period.
However, in all other circumstances the
State agency may provide for issuance
through an alternative means such as
EBT or mailing, unless FNS determines
that such actions would jeopardize the
integrity of program services or program
accountability. If a State agency opts to
mail food instruments and cash-value
vouchers, it must provide justification,
as part of its alternative issuance system
in its State Plan, as required in
§ 246.4(a)(21), for mailing food
instruments and cash-value voucher to
areas where food stamps are not mailed.
State agencies that opt to mail food
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instruments and cash-value vouchers
must establish and implement a system
that ensures the return of food
instruments and cash-value vouchers to
the State or local agency if a participant
no longer resides or receives mail at the
address to which the food instruments
and cash-value vouchers were mailed;
and
(5) Maximum issuance of food
instruments and cash-value voucher.
Ensure that no more than a three-month
supply of food instruments and cashvalue vouchers or a one-month supply
of authorized supplemental foods is
issued at any one time to any
participant, parent or caretaker of an
infant or child participant, or proxy.
(s) Payment to vendors, farmers and
home food delivery contractors. The
State agency must ensure that vendors,
farmers and home food delivery
contractors are paid promptly. Payment
must be made within 60 days after valid
food instruments or cash-value vouchers
are submitted for redemption. Actual
payment to vendors, farmers and home
food delivery contractors may be made
by local agencies.
*
*
*
*
*
(v) Farmers. The State agency may
authorize farmers at farmers markets (or
roadside stands) to accept the cashvalue voucher for eligible fruits and
vegetables. The State agency must enter
into written agreements with all
authorized farmers. The agreement must
be signed by a representative who has
legal authority to obligate the farmer
and a representative of the State agency.
The agreement must be for a period not
to exceed three years. Only farmers
authorized by the State agency may
redeem the fruit and vegetable cashvalue voucher. The State agency must
require farmers to reapply at the
expiration of their agreements and must
provide farmers with not less than 15
days advance written notice of the
expiration of the agreement.
(1) The agreement must include the
following provisions, although the State
agency may determine the exact
wording. The farmer must:
(i) Assure that the cash-value voucher
is redeemed only for eligible fruits and
vegetables as defined by the State
agency;
(ii) Provide eligible fruits and
vegetables at the current price or less
than the current price charged to other
customers;
(iii) Accept the cash-value voucher
within the dates of their validity and
submit such vouchers for payment
within the allowable time period
established by the State agency;
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(iv) Redeem the cash-value voucher in
accordance with a procedure
established by the State agency,
(v) Accept training on cash-value
voucher procedures and provide
training to any employees with cashvalue voucher responsibilities on such
procedures;
(vi) Agree to be monitored for
compliance with program requirements,
including both overt and covert
monitoring;
(vii) Be accountable for actions of
employees in the provision of
authorized foods and related activities;
(viii) Pay the State agency for any
cash-value vouchers transacted in
violation of this agreement;
(ix) Offer WIC participants, parent or
caretakers of child participants or
proxies the same courtesies as other
customers;
(x) Comply with the
nondiscrimination provisions of USDA
regulations as provided in § 248.7; and
(xi) Notify the State agency if any
farmers’ market ceases operation prior
to the end of the authorization period.
(2) The farmer must not:
(i) Collect sales tax on cash-value
voucher purchases;
(ii) Seek restitution from WIC
participants, parent or caretakers of
child participants or proxies for cashvalue vouchers not paid or partially
paid by the State agency;
(iii) Issue cash change for purchases
that are in an amount less than the value
of the cash-value voucher;
(3) Neither the State agency nor the
farmer has an obligation to renew the
agreement. Either the State agency or
the farmer may terminate the agreement
for cause after providing advance
written notification.
(4) The State agency may deny
payment to the farmer for improperly
redeemed cash-value vouchers and may
demand refunds for payments already
made on improperly redeemed
vouchers.
(5) The State agency may disqualify a
farmer for WIC Program abuse. The
farmer has the right to appeal a denial
of an application to participate, a
disqualification, or a program sanction
by the State agency. Expiration of an
agreement with a farmer and claims
actions under § 246.23, are not
appealable.
(6) A farmer which commits fraud or
engages in other illegal activity is liable
to prosecution under applicable Federal,
State or local laws.
I 7. In § 246.16, add a new paragraph (j)
to read as follows:
§ 246.16
*
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Distribution of funds.
*
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(j) Inflation adjustment of the fruit
and vegetable voucher. The monthly
cash value of the fruit and vegetable
voucher shall be adjusted annually for
inflation. Adjustments are effective the
first day of each fiscal year beginning on
or after October 1, 2008. The inflationadjusted value of the voucher shall be
equal to a base value increased by a
factor based on the Consumer Price
Index for fresh fruits and vegetables, as
provided in this section.
(1) Adjustment year. The adjustment
year is the fiscal year that begins
October 1 of the current calendar year.
(2) Base value of the fruit and
vegetable voucher. The base value of the
fruit and vegetable voucher is the
monthly cash value of the voucher for
fiscal year 2008. The base value equals:
(i) $6 for children;
(ii) $8 for pregnant and postpartum
women; and
(iii) $10 for breastfeeding women.
(3) Adjusted value of the fruit and
vegetable voucher. The adjusted value of
the fruit and vegetable voucher is the
cash value of the voucher for adjustment
years beginning on or after October 1,
2008. The adjusted value is the base
value increased by an amount equal to
the base value of the fruit and vegetable
voucher:
(i) Multiplied by the inflation
adjustment described in paragraph (j)(4)
of this section; and
(ii) Subject to rounding as described
in paragraph (j)(5) of this section.
(4) Inflation adjustment. The inflation
adjustment of the fruit and vegetable
voucher shall equal the percentage (if
any) by which the annual average value
of the Consumer Price Index for fresh
fruits and vegetables, computed from
monthly values published by the Bureau
of Labor Statistics, for the twelve
months ending on March 31 of the fiscal
year immediately prior to the
adjustment year, exceeds the average of
the monthly values of that index for the
twelve months ending on March 31,
2007.
(5) Rounding. If any increase in the
cash value of the voucher determined
under paragraph (j)(3) of this section is
not a multiple of $1, such increase shall
be rounded to the next lowest multiple
of $1. However, if the adjusted value of
the voucher for the adjustment year, as
determined under paragraph (j)(3) of
this section, is lower than the adjusted
value for the fiscal year immediately
prior to the adjustment year, then the
adjusted value of the voucher will
remain unchanged from that immediate
prior fiscal year.
I 8. In § 246.18:
I a. Amend paragraph (a)(1)(iii)(G) by
removing the words ‘‘food instrument’’
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and adding in their place the words
‘‘food instrument or cash-value
voucher’’;
I b. Add a new paragraph (a)(4);
I c. Revise the introductory text of
paragraph (b);
I d. Amend paragraph (d) by removing
the words ‘‘local agency or a vendor’’
and adding in their place the words
‘‘local agency, farmer or vendor’’;
I e. Amend paragraph (e) by removing
the words ‘‘vendor or the local agency’’
and adding in their place the words
‘‘vendor, farmer or local agency’’; and
I f. Amend paragraph (f) by removing
the words ‘‘vendor or local agency’’
wherever they appear and adding in
their place the words ‘‘vendor, farmer or
local agency’’.
The addition and revision read as
follows:
§ 246.18 Administrative review of State
agency actions.
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(a) * * *
(4) Farmer appeals—(i) Adverse
Actions. The State agency shall provide
a hearing procedure whereby farmers
adversely affected by certain actions of
the State agency may appeal those
actions. A farmer may appeal an action
of the State agency denying its
application to participate, imposing a
sanction, or disqualifying it from
participation in the program. Expiration
of an agreement is not subject to appeal.
(ii) Effective date of adverse actions
against farmers. The State agency must
make denials of authorization and
disqualifications effective on the date of
receipt of the notice of adverse action.
The State agency must make all other
adverse actions effective no earlier than
15 days after the date of the notice of the
adverse action and no later than 90 days
after the date of the notice of adverse
action or, in the case of an adverse
action that is subject to administrative
review, no later than the date the farmer
receives the review decision.
(b) Full administrative review
procedures. The State agency must
develop procedures for a full
administrative review of the adverse
actions listed in paragraphs (a)(1)(i),
(a)(3) and (a)(4) of this section. At a
minimum, these procedures must
provide the vendor, farmer or local
agency with the following:
*
*
*
*
*
I 9. In § 246.23, revise paragraph (a)(4)
to read as follows:
§ 246.23
Claims and penalties.
(a) * * *
(4) FNS will establish a claim against
any State agency that has not accounted
for the disposition of all redeemed food
instruments and cash-value vouchers
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and taken appropriate follow-up action
on all redeemed food instruments and
cash-value vouchers that cannot be
matched against valid enrollment and
issuance records, including cases that
may involve fraud, unless the State
agency has demonstrated to the
satisfaction of FNS that it has:
(i) Made every reasonable effort to
comply with this requirement;
(ii) Identified the reasons for its
inability to account for the disposition
of each redeemed food instrument or
cash-value voucher; and
(iii) Provided assurances that, to the
extent considered necessary by FNS, it
will take appropriate actions to improve
its procedures.
*
*
*
*
*
Dated: November 21, 2007.
Nancy Montanez Johner,
Under Secretary for Food, Nutrition and
Consumer Services.
Appendix
Note: This appendix will not be published
in the Code of Federal Regulations.
Regulatory Impact Analysis
7 CFR Part 246: Special Supplemental
Nutrition Program for Women, Infants, and
Children (WIC): Revisions in the WIC Food
Packages
Interim Rule
Executive Summary
The WIC program addresses the
supplemental nutritional needs of at-risk
groups through the distribution of
supplemental food packages, and a program
of nutrition education that includes
counseling, health and social service
referrals, and breastfeeding promotion and
support. WIC nutrition education provisions
are governed by broad regulatory language
that allows nutrition education provided to
participants to respond to the supplemental
nutrition needs of participants in light of
changes in dietary and health research. In
contrast, WIC supplemental food packages
are defined very specifically in regulatory
language. Consequently, as the population
served by WIC has grown and become more
diverse over the last 27 years and as food
consumption habits have changed, the
nutritional risks faced by participants have
changed. Also, though nutrition science has
advanced, the WIC supplemental food
packages have remained largely unchanged.
The interim rule modifies regulations
governing the WIC food packages to
implement recommended changes based on
the current supplemental nutritional needs of
WIC participants and advances in nutrition
science. Specifically, the interim rule: revises
the maximum monthly allowances and
minimum requirements for certain
supplemental foods; revises the substitution
rates for certain supplemental foods and
allows additional foods as alternatives;
revises age specifications for assignment to
infant food packages; modifies food packages
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to promote breastfeeding; adds foods to
children and women food packages; and,
addresses general provisions that apply to all
food packages. The revisions reflect
recommendations made by the Institute of
Medicine of the National Academies in its
Report WIC Food Packages: Time for a
Change, comments received on the Proposed
Rule published in the Federal Register on
August 7, 2006 (71 FR 44784), and certain
administrative revisions found necessary by
the Department.
The revisions also bring the WIC food
packages in line with the 2005 Dietary
Guidelines for Americans and current infant
feeding practice guidelines of the American
Academy of Pediatrics to: better promote and
support the establishment of successful longterm breastfeeding; provide WIC participants
with a wider variety of food; provide WIC
State agencies with greater flexibility in
prescribing food packages to accommodate
participants with cultural food preferences;
and, serve all participants with certain
medical provisions under one food package
to facilitate efficient management of
participants with special dietary needs.
This impact analysis specifically addresses
significant or substantial public comments
and Department modifications from the
provisions as initially proposed in the
Proposed Rule. Unless otherwise stated, the
provisions stated in the impact analysis for
the Proposed Rule should be regarded as the
basis for the impact analysis of the interim
rule. Under the interim rule, revisions to the
WIC food packages are cost-neutral to the
Federal Government. Specifically, FNS
estimates that the changes will decrease costs
by $29.7 million over five years, a negligible
amount relative to the program’s annual cost
of more than $5 billion.
While the additional program costs from
the rule change are negligible, the changes in
food packages that will result represent
important improvements in the program’s
alignment with current dietary guidance,
increase the variety and appropriateness of
foods provided to clients, and better promote
healthy eating behaviors. These benefits will
improve the program relative to current rules
for years to come.
Table of Contents
Action
Nature
Need
Affected Parties
Effects
Background
Summary of Rule and Benefits
Food Package I
Food Package II
Food Package III
Food Package IV
Food Package V
Food Package VI
Food Package VII
Other Provisions
Summary of Key Provisions
Costs
Interim Rule
Major Cost Drivers
Fruit and Vegetables Option
Cost Estimate Methodology
Overview
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Food Package Costs
Prescriptions
Infant Formula and Rounding
Redemption Rates
Food Prices
Participant Projections
Phased Implementation
State Cost Variation
Administrative Costs
Uncertainties
Price Volatility in the Dairy Market
Assumed Preference for Soy Beverage
State Option to Provide Formula for Infants
0–0.9 Months of Age
Prescription Assumptions for Whole Grain
Bread and Bread substitutes
Prescription Assumptions for Infant Food
Fruits, Vegetables, and Meat
Changes in Current Food Package Sizes
Uncertainties Summary
Alternatives
Include Yogurt as a Milk Substitute for
Food Packages IV–VII
Increase the Whole Grain Maximum
Allowance
Fresh Fruit and Vegetables for Infants
Soy Beverage Substitution for Children
without Medical Documentation
Market Share Analysis
Appendix A: Additional Cost Estimate
Assumptions
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Date: November 5, 2007.
Agency: USDA, Food and Nutrition
Service.
Contact: Ed Herzog.
Phone: (703) 305–2340.
Fax: (703) 305–2576.
E-mail: edward.herzog@fns.usda.gov.
Title: 7 CFR Part 246: Special
Supplemental Nutrition Program for Women,
Infants, and Children (WIC): Revisions in the
WIC Food Packages.
Action
A. Nature: Interim Rule.
B. Need: The WIC program addresses the
supplemental nutritional needs of at-risk
groups through the distribution of age and
condition specific food packages, and a
program of nutrition education that includes
counseling, health and social service
referrals, and breastfeeding promotion and
support. WIC nutrition education provisions
are governed by broad regulatory language
that allows nutrition education provided to
participants to respond to changes in dietary
and health research. In contrast, WIC
supplemental food packages are defined very
specifically in the regulatory language.
Consequently, as the population served by
WIC has grown and become more diverse
over the last 27 years, the nutritional risks
faced by participants have changed, and
though nutrition science has advanced, the
WIC supplemental food packages have
remained largely unchanged. This rule is
needed to implement recommended changes
to the WIC food packages based on the
current supplemental nutritional needs of
WIC participants and advances in nutrition
science.
C. Affected Parties: The program affected
by this rule is the Special Supplemental
Nutrition Program for Women, Infants, and
Children (WIC). The parties affected by this
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regulation are the USDA’s Food and
Nutrition Service (FNS), State and local
agencies that administer the WIC Program,
retail vendors, food producers and
manufacturers, and WIC participants.
Effects
The following analysis describes the
potential economic impact of the interim
rule. This rule is needed due to changes in
the population served by WIC, and advances
in nutrition and knowledge about the
supplemental nutritional needs of those
served by WIC. The changes in this rule are
significant to the costs or overall operations
to the program. The potential effects of these
changes are highlighted below.
A. Background
The WIC program was established in the
1970s to address the special supplemental
nutritional needs of low-income pregnant
and postpartum women, infants, and
children up to age five who are determined
to be at nutritional risk. Regulations
governing the WIC program recognize a broad
range of nutritionally related medical
conditions for purposes of establishing
program eligibility. These include anemia,
low birth weight, chronic infections,
overweight, underweight, and similar
manifestations of poor nutrition suitable for
direct measurement or diagnosis.1 WIC
regulations also recognize that personal
medical histories, dietary patterns, and
economic circumstances may put otherwise
healthy women or children at nutritional
risk. Certification may therefore be extended
to women facing high-risk pregnancies,
pregnant women or mothers who abuse
alcohol or drugs, homeless women and
children, and infants and children with
congenital malformations or other medical
conditions that may interfere with adequate
nutrient intake or absorption.
WIC addresses the supplemental
nutritional needs of at-risk groups through
the distribution of age- and conditionspecific food packages, and a program of
nutrition education that includes counseling,
health and social service referrals, and
breastfeeding promotion and support.
Supplemental foods are currently offered to
WIC participants in one of seven packages
designed for the special supplemental
nutritional needs of the following subpopulations:
I. Infants under four months old
II. Infants from four to twelve months old
III. Children and women with special dietary
needs
IV. Children from one to five years old
V. Pregnant and breastfeeding women
VI. Non-breastfeeding postpartum women
VII. Exclusively breastfeeding women
Inadequate nutrition was the prime
motivating factor behind the enactment of the
WIC program.2 Nutrition research in the
1970s pointed to calcium, iron, high quality
protein, and vitamins A and C as nutrients
most likely to be lacking in the diets of lowincome women, infants, and children.
Current WIC food packages reflect that early
17
CFR 246.7(e).
42 U.S.C. 1786(a).
2 See
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research. Today’s packages include some
combination of: iron-fortified infant
formulas, iron-fortified cereals, vitamin C
rich juice, vitamin A and D fortified milk,
eggs, cheese, dried beans or peas, peanut
butter, tuna, and carrots. Other factors that
contributed to the selection of these foods are
their nutrient density, modest cost, wide
availability, and broad acceptance by the
WIC-eligible population.
WIC’s nutrition education provisions are
governed by broad regulatory language that
seeks to promote ‘‘proper nutrition,’’
‘‘optimal use’’ of WIC’s supplemental foods,
and appropriate advice concerning non-WIC
foods.3 Compliance with this regulatory
mandate presumes that nutrition education
will respond to the supplemental nutrition
needs of participants based on advances in
dietary and health research. The U.S.
Department of Agriculture’s (USDA) Food
and Nutrition Service (FNS) provides for
provision of nutrition education to WIC
participants that is consistent with the
Dietary Guidelines for Americans.
The statute governing WIC directs the
Secretary of Agriculture to prescribe
supplemental food packages for the
program.4 As a result, the content of WIC
food packages is defined with specificity in
program regulations; the regulatory flexibility
that characterizes WIC nutrition education
does not extend to the prescription of
individual food packages. The list of WICapproved foods provides select, nutrient-rich
foods; allowed substitutions provide only
limited room for participant-specific food
package tailoring.
The population served by the WIC program
has grown in size and diversity over time and
the frequency of nutritional risks faced by
WIC participants have changed. White and
Black participants represented 72% of the
WIC population in 1992; by 2004, just 56%
of WIC participants fell into one of those two
racial/ethnic groups.5 WIC’s Hispanic
population, itself a diverse group, has grown
from the third largest to the largest over the
same period. Greater ethnic diversity
increases the demand for additional food
options consistent with cultural preferences.
In addition, the nutritional risks faced by
the low-income population of the 1970s have
changed. Although inadequate intake of some
nutrients remains a concern,6 improved diets
have reduced the prevalence of once
relatively common deficiency diseases and
37
CFR 246.11.
U.S.C. 1786(b)(14).
5 U.S. Department of Agriculture, Food and
Nutrition Service, Office of Analysis, Nutrition and
Evaluation, WIC Participant and Program
Characteristics 1992, Abt Associates. Alexandria,
VA: 1994. U.S. Department of Agriculture, Food
and Nutrition Service, Office of Analysis, Nutrition
and Evaluation, WIC Participant and Program
Characteristics 2004, Abt. Associates. Alexandria,
VA: 2005. The program characteristics studies
performed prior to 1992 did not include participant
data from Alaska, Hawaii, Puerto Rico, or U.S.
territories. The racial/ethnic breakdowns from those
earlier reports should not be directly compared to
the ones contained in reports from 1992 forward.
6 National Academies, Institute of Medicine
(IOM). WIC Food Packages: Time for a Change,
Washington, DC: The National Academies Press,
2005. pp. 31, 64.
4 42
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underweight in at-risk groups. A WIC
program that now assists nearly eight million
individuals monthly, including about half of
the nation’s infants,7 supplements the diets
of an at-risk population with the very types
of iron-fortified, nutrient-dense foods
associated with this changed health picture.
WIC’s current food packages, little modified
since the 1970s, were appropriately designed
to address the recognized nutritional
priorities of that time. But today’s WIC
population, like the U.S. population as a
whole, faces a reordered set of priorities.
Excessive intakes of some nutrients,
including saturated fat, and of food energy
have taken a place among the nation’s top
public health concerns.8 Other nutrients,
including vitamin E, and fiber, have since
been identified as lacking in the diets of WICeligible sub-populations.9 While current WIC
food packages continue to address important
health risks of undernutrition, they do not
target all identified inadequacies, and they
may contribute to the risks associated with
excessive intake of some nutrients.
Medical consequences of improper diets
include fetal or infant lead toxicity tied to
low calcium intake by pregnant and
breastfeeding women, birth defects caused by
inadequate folate consumption early in
pregnancy, iron-deficiency anemia, and heart
disease, diabetes, stroke, and cancer, all
linked to obesity and excessive intake of
saturated fat.10 Adjustments to the WIC food
packages that move individual consumption
of these priority nutrients closer to
Recommended Dietary Allowances (RDAs)
and Adequate Intake (AIs) levels of the
Institute of Medicine’s Dietary Reference
Intakes may reduce the nutrition-related
medical health risks of WIC participants.
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B. Summary of Rule and Benefits
FNS contracted with the National
Academies’ Institute of Medicine (IOM) in
2003 to assess the nutritional health profile
of the current WIC population, and to
recommend changes in the content of the
program’s food packages. The Proposed Rule
largely reflected recommendations made by
the National Academies’ Institute of
Medicine (IOM) in its Report WIC Food
Packages: Time for a Change, with certain
7 U.S. Department of Agriculture, Food and
Nutrition Web site, July 2005. www.fns.usda.gov/
wic/FAQs/FAQ.HTM.
8 See U.S. Department of Health and Human
Services and U.S. Department of Agriculture,
Dietary Guidelines for Americans, 2005, 6th edition,
Washington DC: U.S. Government Printing Office,
January 2005. (USDHHS/USDA, 2005)
9 IOM, p.59. Note, however, that these
conclusions are based on self-reported food
consumption data from the Continuing Survey of
Food Intakes by Individuals (1994–1996 and 1998.)
Underreporting of food intakes is suspected by
women involved in the survey. And, the data do not
include nutrients consumed in the form of dietary
supplements. These factors may overstate the
problem of nutrient inadequacies, and may
understate the problem of excessive intakes.
10 See IOM, p. 63; see also ‘‘High Costs of Poor
Eating Patterns in the United States,’’ Elizabeth
˜
Frazao, in America’s Eating Habits: Changes and
˜
Consequences, Elizabeth Frazao, ed., Economic
Research Service, U.S. Department of Agriculture,
Washington, DC, 1999.
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cost containment and administrative
modification found necessary by the
Department to ensure cost neutrality.
The Proposed Rule detailed the first
comprehensive revisions to the WIC food
packages since 1980. The revised food
packages were developed to better reflect
current nutrition science and dietary
recommendations than do current food
packages, without impacting overall program
costs. Compared to current WIC packages, the
proposal:
Provides greater consistency with the
Dietary Guidelines for Americans. The
interim rule adds fruits and vegetables, and
whole grains to the packages for the first
time. The revised packages include foods
from each food group except oils and allow
variety and choice within the groups.
Reductions are made to the amounts
provided for certain foods in the current
packages in order to be more consistent with
the amounts of these foods recommended in
the 2005 Dietary Guidelines for Americans
and WIC’s role as a supplemental nutrition
program.
Supports improved nutrient intakes. The
interim rule adds additional foods and
modifies amounts of current foods support
overall improvement in nutrient
consumption and reduction in the prevalence
of inadequate or excessive nutrient intakes.
Compared with the current food packages,
the revised packages are estimated to provide
greater amounts of nearly all the nutrients
identified by the IOM as often lacking in the
diets of the WIC-eligible population, such as
iron, fiber, and vitamin E. The revised food
packages for women and children also
provide less saturated fat, cholesterol, total
fat and sodium than the current packages.
Provides greater consistency with
established dietary recommendations for
infants and children under 2, including
encouragement and support for
breastfeeding. The revised infant food
packages improve overall nutrient density
compared to current packages while keeping
caloric content the same or slightly lower.
The revised packages change age
specification for assignment as well as
establish three feeding categories to better
address current dietary recommendations of
the American Academy of Pediatrics (AAP)
and promote breastfeeding. The packages for
breastfeeding infant-mother pairs are revised
to provide stronger incentives for continued
breastfeeding, including providing less
formula to partially breastfed infants than
current packages, and providing additional
quantities/types of food for breastfeeding
mothers. For older infants, the proposal
delays the introduction of complementary
foods, consistent with AAP, from four to six
months of age and modifies formula
amounts. Infant foods are added and juice
eliminated in the packages for older infants
in order to promote healthy dietary patterns.
Addresses Emerging Public Health
Nutrition-Related Issues. The prevalence of
overweight and obesity in adults,
adolescents, and children have increased
dramatically, with direct implications for
WIC participants. For example, childhood
overweight has been linked to adverse health
outcomes including elevated blood pressure,
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hyperinsulinemia, glucose intolerance, type 2
diabetes, dyslipidemia, and other early risks
for chronic disease. The addition of fruits
and vegetables and the emphasis on whole
grains are consistent with recommendations
for food patterns that may contribute to a
healthy body weight. Compared to the
current food packages, the revised food
packages provide less saturated fat and
cholesterol than the current packages for
women and children. In addition, the revised
food packages are designed to encourage
breastfeeding and thus may contribute to a
reduced risk of overweight in children.
Provides Wide Appeal to Diverse
Populations. The proposed additional foods
are the foods most often requested over the
years by a variety of stakeholders such as the
National WIC Association, WIC participants,
WIC State and local agencies, industry and
health professionals, and would provide
more participant choice and a wider variety
of foods than the current food packages. The
increased variety and choice will provide
State agencies increased flexibility in
prescribing culturally appropriate food
packages.
The Proposed Rule was published in the
Federal Register on August 7, 2006 (71 FR
44784), with a 90-day comment period. A
total of 46,502 comment letters were received
on the Proposed Rule; of those, 23,908 were
form letters. Comments were submitted by a
variety of stakeholders, including program
participants, WIC State and local agencies
and Indian Tribal Organizations, the National
WIC Association, professional organizations
and associations, advocacy groups,
healthcare professionals (including
universities), members of Congress, the food
industry, vendors, farmers, and private
citizens.
With few changes, the provisions in the
Proposed Rule have been adopted as this
interim rule. This impact analysis
specifically addresses significant or
substantial public comments and Department
modifications from the provisions as initially
proposed. Unless otherwise stated, the
provisions stated in the impact analysis for
the Proposed Rule 11 should be regarded as
the basis for the impact analysis of the
interim rule. The provisions of the rule and
the related changes are summarized below.
1. Food Package I—Infants Under Six Months
Proposed rule: Tie maximum infant
formula prescriptions to breastfeeding
practice
• Establish fully breastfed, partially
breastfed, and fully formula-fed categories,
and set maximum formula allowances for
each. Food Package I currently specifies a
single maximum formula amount for all
Package I recipients; local WIC staff may
tailor the amount of formula to reflect
individual participant needs, based on
frequency of breastfeeding. The new rule sets
a maximum formula amount for partially
breastfed infants age one month and older
that is roughly half the maximum provided
to fully formula fed infants.
11 71 FR 44784: Special Supplemental Nutrition
Program for Women, Infants and Children (WIC):
Revisions in the WIC Food Packages: Proposed
Rule, August 7, 2006, p. 44825.
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• Powder formula alone is recommended
for partially breastfed infants. Powder and
non-powder options remain available for
fully formula fed infants.
Interim rule: No change from Proposed
Rule.
Proposed rule: Delay introduction of
complementary foods. Extend the age range
of infants covered by Food Package I by two
months. Currently, Food Package I
supplements the diets of infants from birth
through three months. Under the proposed
rule, Food Package I would be provided to
infants through five months of age. Under
both the current and proposed rules, Food
Package I contains no complementary foods.
Extending the age range of infants served by
Food Package I removes complementary
foods (juice and infant cereal) from the food
packages for four and five-month-old infants,
which is consistent with current infant
feeding practice guidelines.
Interim rule: No change from Proposed
Rule.
Proposed rule: Increase maximum formula
prescription at four months. Increase the
maximum amount of formula allowed for
four and five-month-old infants (relative to
the amount allowed under current rules.)
Interim rule: No change from Proposed
Rule.
Proposed rule: No partially breastfed
category for infants under one month. Do not
provide formula to breastfed infants under
one month old. Infants under one month will
be recognized as either fully breastfed or
fully formula-fed. No infant will be
prescribed formula in the amount specified
by Food Package I for partially breastfed
infants until he or she reaches one month.
Interim rule: Provide formula to partially
breastfed infants under one month. Partially
breastfed infants ages 0 through 1 month may
receive the equivalent of not more than 104
fluid ounces of reconstituted infant formula,
approximately one can of powder infant
formula.
Rationale: The interim rule intends to
encourage mothers to continue a practice of
breastfeeding that may have begun at the
hospital. However, FNS recognizes the need
for States to have the flexibility to provide a
small amount of formula in the first month
of life, if necessary, to assist breastfeeding
mothers who may otherwise choose to
formula feed. Powder infant formula is
recommended due to its longer shelf life and
to minimize waste. Individual amounts may
be tailored by a Competent Professional
Authority based on the assessed needs of the
breastfeeding infant.
Proposed rule: No low iron formula.
Discontinue the prescription of low iron
infant formula for infants of all ages.
Interim rule: No change from Proposed
Rule.
Proposed rule: Reclassify prescriptions of
exempt infant formula under Package III.
Administer exempt formulas, other than
those prescribed for common food allergies,
under Food Package III. Currently, all infants
are classified as recipients of Food Packages
I or II. This proposal would simply reclassify
certain Package I (and II) recipients as
Package III recipients; it is not intended to
alter the types of foods prescribed to infants
with qualifying conditions.
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Interim rule: No change from Proposed
Rule.
2. Food Package II—Infants 6 Through 11
Months
Proposed rule: Delay introduction of
complementary foods. Delay the age at which
infants become eligible for Food Package II.
Infants are currently made eligible for Food
Package II and its complementary foods at
four months of age. The proposed rule would
make infants age one month or older eligible
for Package II foods at six months of age.
Interim rule: No change from Proposed
Rule.
Proposed rule: Tie maximum formula
prescription to breastfeeding practice.
Establish fully breastfed, partially breastfed,
and fully formula-fed categories, and set
maximum formula allowances for each. The
new rule sets a maximum formula amount for
partially breastfed infants that is roughly half
the maximum provided to fully formula-fed
infants.
Interim rule: No change from Proposed
Rule.
Proposed rule: Reduce maximum formula
prescription amounts. Reduce the amount of
formula, relative to current rules, for partially
breastfed and fully formula-fed infants.
Interim rule: No change from Proposed
Rule.
Proposed rule: Replace infant’s juice with
fruits and vegetables
• Eliminate juice from Food Package II.
Add infant food fruits and vegetables to the
package. Allow fresh bananas as a substitute
for a portion of the infant food fruits and
vegetables.
• Provide more infant food fruits and
vegetables to fully breastfed infants than to
partially breastfed or fully formula-fed
infants.
Interim rule: No change from Proposed
Rule.
Proposed rule: Provide infant food meat to
fully breastfed infants. Add infant food meat
to Package II for fully breastfed infants.
Interim rule: No change from Proposed
Rule.
Proposed rule: No low iron formula.
Discontinue the prescription of low iron
infant formula.
Interim rule: No change from Proposed
Rule.
Proposed rule: Reclassify prescriptions of
exempt infant formula under Package III.
Administer exempt formulas to infants under
Food Package III.
Interim rule: No change from Proposed
Rule.
Proposed rule: Disallow prescription of
infant cereal with added ingredients. Infant
cereal with added fruit, milk, formula, or
other non-grain foods may not be prescribed
under Food Package II.
Interim rule: No change from Proposed
Rule.
3. Food Package III—Medically Fragile
Participants
Proposed rule: Administer exempt
formulas to infants with qualifying
conditions under Package III
Infants with a qualifying condition (see
below) who currently receive exempt infant
formulas would be moved from Package I or
Package II to Package III.
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Interim rule: In addition to the provisions
of the Proposed Rule, the interim rule will
allow medically fragile infants 6 months of
age or greater whose medical condition
prevents them from consuming
complementary infant foods (cereal, fruit and
vegetables, and meat) to receive exempt
infant formula or WIC-eligible medical foods
at the same maximum monthly allowance as
infants ages 4 through 5 months of the same
feeding option.
Rationale: Comments expressed concern
about medically fragile infants 6 months of
age or greater whose medical condition
prevents them from consuming
complementary infant foods. The allowance
of exempt infant formula or WIC-eligible
medical foods will replace nutrition that
would result from the addition of
complementary foods.
Proposal Rule: Clarify language governing
Package III’s purpose and scope
• The proposed rule would provide
additional guidance to States on the nature
of medical conditions that qualify a WIC
participant for Package III medical foods.
• Prescription of a medical food would
also require additional justification and
instructions by a licensed health care
professional.
Interim rule: No change from Proposed
Rule.
Proposed rule: Make non-Package III foods
available to Package III recipients. In
addition to the medical foods and exempt
formulas currently prescribed to Package III
recipients, the proposed rule would offer
these individuals all of the foods in the
packages to which they would have been
eligible in the absence of their special
medical needs.
Interim rule: No change from Proposed
Rule, with the exception of whole milk.
Whole milk will be authorized for children
1 through 4 years of age and women
receiving Food Package III, with medical
documentation.
4. Food Package IV—Children From Age One
up to Age Five
Proposed rule: Reduce the prescribed
amount of milk; modify substitution options
• The maximum amount of milk that may
be prescribed to children would be reduced
from 24 quarts to 16 quarts per month.
• Under current rules, cheese may be
prescribed as a substitute for up to 12 quarts
of milk. The proposed rule would allow
cheese to replace up to three quarts of milk.
The substitution rate of one pound of cheese
for three quarts of milk would remain
unchanged.
• Soy products will be allowed as a milk
substitute on a restricted basis; soy may only
be prescribed to children with a documented
medical need.
Interim rule: In addition to the provisions
of the Proposed Rule, the interim rule
clarifies the authorization of lactose-reduced
and lactose-free milk, and that these products
should be offered before other authorized
milk substitutes to those participants who
cannot drink milk due to lactose intolerance.
The interim rule also clarifies that medical
documentation is not required for
participants to receive lactose-reduced and
lactose-free milk.
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Rationale: The IOM emphasized the
importance of milk in the diets of WIC
participants, and approached the issue of
milk substitutes with caution. The IOM
considered and rejected the substitution of
soy products for milk in the revised
childrens’ food package without documented
medical need.
Proposed rule: Provide only fat-reduced
milk to older children. Prescribe only fatreduced milk to children age two and above.
Prescribe only whole milk to children under
age two.
Interim rule: No change from Proposed
Rule.
Proposed rule: Modify/clarify
reconstitution rates for dry and evaporated
milk. The reconstitution rate for evaporated
milk is changed from 13 to 16 ounces of
evaporated milk per reconstituted quart. The
reconstitution rate for powdered milk is
restated in terms of fluid ounces rather than
quarts; this change does not alter the
reconstitution rate itself.
Interim rule: No change from Proposed
Rule.
Proposed rule: Reduce juice prescriptions;
add fruits and vegetables.
• Reduce monthly maximum juice
prescription from 288 fluid ounces to 128.
Clarify that juice must be 100% unsweetened
fruit or vegetable juice, that it contain a
minimum of 30 milligrams of vitamin C per
100 milliliters, and that it be pasteurized.
• Add a $6 monthly voucher to the
package for the purchase of any combination
of fresh or processed fruits and vegetables
other than white potatoes.
Interim rule: No change from Proposed
Rule.
Proposed rule: Add whole grain breads;
add whole grain requirement to cereal.
• Add two pounds of whole grain bread to
the food package. Only bread meeting U.S.
Food and Drug Administration (FDA)
standards for whole grain labeling would be
allowed.12
• Several whole grain products would be
allowed as substitutions for bread. These
include brown rice, bulgur, and whole grain
barley without added sugar, fat, oil, or
sodium. Soft corn or whole wheat tortillas
would be allowed as an additional substitute
at the option of State agencies. States may
limit or completely eliminate substitutes if
needed to control food costs.
• Require that WIC authorized breakfast
cereals 13 meet the same whole grain
requirements as bread.
Interim rule: Revise proposed whole grain
requirements.
• The cereal whole grain requirement in
the Proposed Rule will be modified to require
that at least one half of the total number of
breakfast cereals on a State’s authorized food
list meet the whole grain requirement as
defined in the interim rule, and that vendors
be required to stock at least one whole grain
12 See 21 CFR Part 136, Section 136.180, and
FDA’s Health Claim Notification for Whole Grain
Foods with Moderate Fat Content at https://
www.cfsan.fda.gov/dms/flgrain2.html.
13 The proposed rule would also replace the
existing terms ‘‘cereal (hot or cold)’’ and ‘‘adult
cereal (hot or cold)’’ with ‘‘breakfast cereal’’ in 7
CFR 246.10(c).
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cereal. The remaining authorized breakfast
cereals are required to meet only the iron and
sugar requirements.
• To assist in the identification of whole
grain bread, cereal, and whole grain foods,
the interim rule adds the requirement that a
whole grain must be the primary ingredient
by weight in all bread, cereal and whole grain
products.
Rationale:
• Comments expressed concern that the
proposed nutritional requirement for whole
grain breakfast cereal (using FDA’s Health
Claim 14) is too restrictive and would
eliminate corn and rice-based cereals that are
necessary for those participants with wheat
allergies or strong preferences for corn and
rice-based cereals. In addition, commenters
stated that whole grain cereals are less
palatable to young children.
• Comments expressed concern about
administrative difficulties in the
identification of whole wheat bread and
whole grain foods. To ensure State agencies
determine the correct foods to authorize for
State food lists, the Department has
determined that whole-grain foods must have
a whole-grain as the primary ingredient. This
will allow products that are 100 percent
whole grain, or are primarily whole wheat or
multi-grain, to be WIC-eligible as well as
provide an easy way for participants and
vendors to identify most whole grain bread
products by using the food ingredient label.15
Proposed rule: Reduce maximum egg
prescription.
Reduce the maximum egg prescription
from two and one-half dozen per month 16 to
one dozen.
Interim rule: No change from Proposed
Rule.
Proposed rule: Allow canned beans as a
substitute for dry beans.
Allow canned beans as a substitute for dry
at the rate of sixty-four ounces per pound.
Interim rule: No change from Proposed
Rule.
5. Food Package V—Pregnant and Partially
Breastfeeding Women Up to One Year
Postpartum
Proposed rule: Condition eligibility for
Package V on breastfeeding practice.
Mothers who request, and are prescribed,
more than the maximum amount of formula
allowed for partially breastfed infants will no
longer be eligible for Food Package V.
Currently, women who breastfeed at least
once per day are eligible for this package.
Reclassified as non-breastfeeding for
purposes of WIC food package issuance,
these women will be assigned Food Package
VI up to six months postpartum; they will
receive no food package after six months.
Interim rule: No change from Proposed
Rule.
Proposed rule: Reduce the prescribed
amount of milk; introduce new substitution
options.
14 See 21 CFR Part 136, Section 136.180, and
FDA’s Health Claim Notification for Whole Grain
Foods with Moderate Fat Content at https://
www.cfsan.fda.gov/dms/flgrain2.html.
15 Baked in-store breads generally have no label.
16 Some states currently allow just two dozen as
the monthly maximum.
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• The maximum amount of milk that may
be prescribed to Package V recipients would
be reduced from 28 quarts to 22 quarts per
month.
• Under current rules, cheese may be
prescribed as a substitute for up to 12 quarts
of milk. The proposed rule would allow
cheese to replace just three quarts of milk.
The substitution rate of one pound of cheese
for three quarts of milk would remain
unchanged.
• Calcium-set tofu 17, and calcium and
vitamin D fortified soy beverage would be
introduced as new milk substitutes. Each
pound of tofu would replace one quart of
milk. For most women, cheese and tofu,
combined, could replace no more than four
quarts of milk; women with documented
medical needs may be prescribed these
substitutes in amounts that exceed the four
quart maximum. No more than one pound of
cheese may be substituted for milk.
• Soy beverage would be allowed as a
substitute for Package V’s entire milk
allowance.
• IOM recommended yogurt as an
alternative to fluid milk. To ensure cost
neutrality yogurt was omitted as a fluid milk
substitution. (See discussion of yogurt as a
milk substitute in Section F, Item 1.)
Interim rule: In addition to the provisions
of the Proposed Rule, the interim rule
clarifies the authorization of lactose-reduced
and lactose-free milk, and that these products
should be offered before other authorized
milk substitutes to those participants who
can not drink milk due to lactose intolerance.
The interim rule also clarifies that medical
documentation is not required for
participants to receive lactose-reduced and
lactose-free milk.
Rationale: Lactose-reduced and lactose-free
milks conform to the FDA standard of
identity. The authorization of these milks
was not specified in the Proposed Rule.
Proposed rule: Reduce maximum juice
prescription; add fruits and vegetables.
• Reduce monthly maximum juice
prescription from 288 fluid ounces to 144.
Clarify that juice must be 100% unsweetened
fruit or vegetable juice, that it contain a
minimum of 30 milligrams of vitamin C per
100 milliliters, and that it be pasteurized.
• Add an $8 monthly voucher to the
package for the purchase of any combination
of fresh or processed fruits and vegetables
other than white potatoes.
Interim rule: No change from Proposed
Rule.
Proposed rule: Add whole grain breads;
add whole grain requirement to cereal.
• Add one pound of whole grain bread to
the food package. Only bread meeting U.S.
Food and Drug Administration (FDA)
standards for whole grain labeling would be
allowed.18
• Several whole grain products would be
allowed as substitutions for bread. These
include brown rice, bulgur, and whole grain
barley without added sugar, fat, oil, or
17 Tofu
prepared with only calcium salts.
21 CFR Part 136, Section 136.180, and
FDA’s Health Claim Notification for Whole Grain
Foods with Moderate Fat Content at https://
www.cfsan.fda.gov/dms/flgrain2.html.
18 See
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sodium. Soft corn or whole wheat tortillas
would be allowed as an additional substitute
at the option of State agencies. States may
limit or completely eliminate substitutes if
needed to control food costs.
• Require that WIC authorized breakfast
cereals meet the same whole grain
requirements as bread.
Interim rule: Revise proposed whole grain
requirements.
• The cereal whole grain requirement in
the Proposed Rule will be modified to require
that at least one half of the total number of
breakfast cereals on a State’s authorized food
list meet the whole grain requirement as
defined in the interim rule, and that vendors
be required to stock at least one whole grain
cereal. The remaining authorized breakfast
cereals are required to meet only the iron and
sugar requirements.
• To assist in the identification of whole
grain bread and whole grain foods, the
interim rule adds the requirement that a
whole grain must be the primary ingredient
by weight in all bread products.
Rationale:
• Comments expressed concern that the
proposed nutritional requirement for whole
grain breakfast cereal (using FDA’s Health
Claim 19) is too restrictive and would
eliminate corn and rice-based cereals that are
necessary for those participants with wheat
allergies or strong preferences for corn and
rice-based cereals.
• Comments expressed concern about
administrative difficulties in the
identification of whole wheat bread and
whole grain foods. To ensure State agencies
determine the correct foods to authorize for
State food lists, the Department has
determined that whole-grain foods must have
a whole-grain as the primary ingredient. This
will allow products that are 100 percent
whole grain, or are primarily whole wheat or
multi-grain, to be WIC-eligible as well as
provide an easy way for participants and
vendors to identify whole grain bread
products by using the food label.
Proposed rule: Reduce maximum egg
prescription.
Reduce the maximum egg prescription
from two and one-half dozen per month to
one dozen.
Interim rule: No change from Proposed
Rule.
Proposed rule: Allow canned beans as a
substitute for dry beans.
Allow canned beans as a substitute for dry
at the rate of sixty-four ounces per pound.
Interim rule: No change from Proposed
Rule.
Proposed rule: Increase total amount of
peanut butter and beans.
Peanut butter is currently offered as a
substitute for dry beans. The proposal would
provide both one pound of dry beans and 18
ounces of peanut butter to Package V
recipients. The rule also clarifies that
Package V recipients may replace both dry
beans and peanut butter with canned beans.
Interim rule: No change from Proposed
Rule.
19 See 21 CFR Part 136, Section 136.180, and
FDA’s Health Claim Notification for Whole Grain
Foods with Moderate Fat Content at https://
www.cfsan.fda.gov/dms/flgrain2.html.
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6. Food Package VI—Postpartum Women (Up
to Six Months Postpartum)
Proposed rule: Reduce the prescribed
amount of milk; introduce new substitution
options.
• The maximum amount of milk that may
be prescribed to Package VI recipients would
be reduced from 24 quarts to 16 quarts per
month.
• Under current rules, cheese may be
prescribed as a substitute for up to 12 quarts
of milk. The proposed rule would allow
cheese to replace just three quarts of milk.
The substitution rate of one pound of cheese
for three quarts of milk would remain
unchanged. Calcium-set tofu, and calcium
and vitamin D fortified soy beverage would
be introduced as new milk substitutes. Each
pound of tofu would replace one quart of
milk. For most women, cheese and tofu,
combined, could replace no more than four
quarts of milk; women with documented
medical needs may be prescribed these
substitutes in amounts that exceed the four
quart maximum. No more than one pound of
cheese may be substituted for milk.
• Soy beverage would be allowed as a
substitute for Package VI’s entire milk
allowance.
• IOM recommended yogurt as an
alternative to fluid milk. To ensure cost
neutrality yogurt was omitted as a fluid milk
substitution. (See discussion of yogurt as a
milk substitute in Section F, Item 1.)
Interim rule: In addition to the provisions
of the Proposed Rule, the interim rule
clarifies the authorization of lactose-reduced
and lactose-free milk, and that these products
should be offered before other authorized
milk substitutes to those participants who
can not drink milk due to lactose intolerance.
The interim rule also clarifies that medical
documentation is not required for
participants to receive lactose-reduced and
lactose-free milk.
Rationale: Lactose-reduced and lactose-free
milks conform to the FDA standard of
identity. The authorization of these milks
was not specified in the Proposed Rule.
Proposed rule: Reduce maximum juice
prescription; add fruits and vegetables.
• Reduce monthly maximum juice
prescription from 192 fluid ounces to 96.
Clarify that juice must be 100% unsweetened
fruit or vegetable juice, that it contain a
minimum of 30 milligrams of vitamin C per
100 milliliters, and that it be pasteurized.
• Add an $8 monthly voucher to the
package for the purchase of any combination
of fresh or processed fruits and vegetables
other than white potatoes.
Interim rule: No change from Proposed
Rule.
Proposed rule: Add whole grain
requirement to cereal.
• Require that WIC authorized breakfast
cereals meet the same whole grain
requirements as bread.
Interim rule: Add whole grain requirement
to cereal.
The cereal whole grain requirement in the
Proposed Rule will be modified to require
that at least one half of the total number of
breakfast cereals on the State’s authorized
food list meet the whole grain requirement as
defined in the interim rule, and that vendors
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69003
be required to stock at least one whole grain
cereal. The remaining authorized breakfast
cereals are required to meet only the iron and
sugar requirements. To assist in the
identification of whole grain cereal, the
interim rule adds the requirement that a
whole grain must be the primary ingredient
by weight.
Rationale:
Comments expressed concern that the
proposed nutritional requirement for whole
grain breakfast cereal (using FDA’s Health
Claim 20) is too restrictive and would
eliminate corn and rice-based cereals that are
necessary for those participants with wheat
allergies or strong preferences for corn and
rice-based cereals. Comments also expressed
concern about administrative difficulties in
the identification of whole wheat bread and
whole grain foods. To ensure State agencies
determine the correct foods to authorize for
State food lists, the Department has
determined that whole-grain foods must have
a whole-grain as the primary ingredient.
Proposed rule: Reduce maximum egg
prescription.
Reduce the maximum egg prescription
from two and one-half dozen per month to
one dozen.
Interim rule: No change from Proposed
Rule.
Proposed rule: Add beans and peanut
butter to the food package.
One pound of dry beans or 18 ounces of
peanut butter would be added to Package VI.
The same canned bean substitution option
added to Packages IV, V, and VII would be
extended to Package VI recipients as well.
Interim rule: No change from Proposed
Rule.
7. Food Package VII—Exclusively
Breastfeeding Women
Proposed rule: Reduce the prescribed
amount of milk; introduce new substitution
options.
• The maximum amount of milk that may
be prescribed to Package VII recipients would
be reduced from 28 quarts to 24 quarts per
month.
• Under current rules, cheese may be
prescribed as a substitute for up to 12 quarts
of milk. The proposed rule would allow
cheese to replace just six quarts of milk. The
substitution rate of one pound of cheese for
three quarts of milk would remain
unchanged.
• Calcium-set tofu, and calcium and
vitamin D fortified soy beverage would be
introduced as new milk substitutes. Each
pound of tofu would replace one quart of
milk. For most women, cheese and tofu,
combined, could replace no more than six
quarts of milk; women with documented
medical needs may be prescribed these
substitutes in amounts that exceed the six
quart maximum. No more than two pounds
of cheese may be substituted for milk.
• Soy beverage would be allowed as a
substitute for Package VII’s entire milk
allowance.
• IOM recommended yogurt as an
alternative to fluid milk. To ensure cost
20 See 21 CFR Part 136, Section 136.180, and
FDA’s Health Claim Notification for Whole Grain
Foods with Moderate Fat Content at https://
www.cfsan.fda.gov/dms/flgrain2.html.
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
neutrality yogurt was omitted as a fluid milk
substitution. (See discussion of yogurt as a
milk substitute in Section F, Item 1.)
Interim rule: In addition to the provisions
of the Proposed Rule, the interim rule
clarifies the authorization of lactose-reduced
and lactose-free milk, and that these products
should be offered before other authorized
milk substitutes to those participants who
can not drink milk due to lactose intolerance.
The interim rule also clarifies that medical
documentation is not required for
participants to receive lactose-reduced and
lactose-free milk.
Rationale: Lactose-reduced and lactose-free
milks conform to the FDA standard of
identity. The authorization of these milks
was not specified in the Proposed Rule.
Proposed rule: Reduce maximum juice
prescription; add fruits and vegetables.
• Reduce monthly maximum juice
prescription from 336 fluid ounces to 144.
Clarify that juice must be 100% unsweetened
fruit or vegetable juice, that it contain a
minimum of 30 milligrams of vitamin C per
100 milliliters, and that it be pasteurized.
• Add an $8 monthly voucher to the
package for the purchase of any combination
of fresh or processed fruits and vegetables
other than white potatoes.
• Eliminate the separate prescription of
carrots.
Interim rule: The provision of an $8
monthly voucher has been revised to reflect
a $10 monthly voucher.
Rationale: IOM recommended cash-value
food instruments for fruits and vegetables at
the level of $10 per month for women. To
ensure cost neutrality, cash-value food
instruments for fruits and vegetable was
decreased to $8 per month for women.
However, FNS has considered the benefits of
increasing the value of the vouchers for fully
breastfeeding women and has determined
that a $2 increase can be accomplished while
maintaining cost neutrality. In addition, the
increase further enhances the attractiveness
of the fully breastfeeding package and
provides an additional incentive for women
to breastfed.
Proposed rule: Add whole grain breads;
add whole grain requirement to cereal.
• Add one pound of whole grain bread to
the food package. Only bread meeting U.S.
Food and Drug Administration (FDA)
standards for whole grain labeling would be
allowed.21
• Several whole grain products would be
allowed as substitutions for bread. These
include brown rice, bulgur, and whole grain
barley without added sugar, fat, oil, or
sodium. Soft corn or whole wheat tortillas
would be allowed as an additional substitute
at the option of State agencies. States may
limit substitutes if needed to control food
costs.
Interim rule: Revise proposed whole grain
requirements.
• The cereal whole grain requirement in
the Proposed Rule will be modified to require
that at least one half of the total number of
breakfast cereals on the State’s authorized
food list meet the whole grain requirement as
defined in the interim rule, and that vendors
be required to stock at least one whole grain
cereal. The remaining authorized breakfast
cereals are required to meet only the iron and
sugar requirements.
• To assist in the identification of whole
grain bread and whole grain foods, the
interim rule adds the requirement that a
whole grain must be the primary ingredient
by weight in all bread products.
Rationale:
• Comments expressed concern that the
proposed nutritional requirement for whole
grain breakfast cereal (using FDA’s Health
Claim 22) is too restrictive and would
eliminate corn and rice-based cereals that are
necessary for those participants with wheat
allergies or strong preferences for corn and
rice-based cereals.
• Comments expressed concern about
administrative difficulties in the
identification of whole wheat bread and
whole grain foods. To ensure State agencies
determine the correct foods to authorize for
State food lists, the Department has
determined that whole-grain foods must have
a whole-grain as the primary ingredient. This
will allow products that are 100% whole
grain, or are primarily whole wheat or multigrain, to be WIC-eligible as well as provide
an easy way for participants and vendors to
identify whole grain bread products by using
the food label.
Proposed rule: Reduce maximum egg
prescription.
Reduce the maximum egg prescription
from two and one-half dozen per month to
one dozen.
Interim rule: No change from Proposed
Rule.
Proposed rule: Allow canned beans as a
substitute for dry beans.
Allow canned beans as a substitute for dry
at the rate of sixty-four ounces per pound.
Also clarifies that Package VII recipients may
replace both dry beans and peanut butter
with canned beans.
Interim rule: No change from Proposed
Rule.
Proposed rule: Modify Package VII’s
canned fish provision.
• Increase the maximum canned fish
prescription to 30 ounces. Clarify that fish
packaged in foil pouches meets WIC
requirements.
• Allow three varieties of canned fish
(light tuna, salmon and sardines) that are
cost-effective and do not pose a mercury
hazard as identified by federal advisories of
the Food and Drug Administration and the
U.S. Environmental Protection Agency for
breastfeeding women.
Interim rule: The interim rule allows
canned mackerel in addition to canned
salmon and sardines, and light tuna.
Rationale: In response to comment
requests, the interim rule also allows canned
mackerel. The rule specifies two species of
mackerel, both of which are also cost-
21 See 21 CFR Part 136, Section 136.180, and
FDA’s Health Claim Notification for Whole Grain
Foods with Moderate Fat Content at https://
www.cfsan.fda.gov/∼dms/flgrain2.html.
22 See 21 CFR Part 136, Section 136.180, and
FDA’s Health Claim Notification for Whole Grain
Foods with Moderate Fat Content at https://
www.cfsan.fda.gov/∼dms/flgrain2.html.
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effective and identified by the EPA and FDA
as having ‘‘lower levels of mercury.’’
8. Other Provisions (Non Food-Package
Specific)
Proposed rule: Clarifies the right of States
to impose restrictions on WIC foods.
States retain the right to exclude particular
products, by brand or variety, from the food
packages distributed to their residents. States
are authorized to set standards for WIC foods
that are more restrictive than those set by the
federal government; however, they may not
authorize the prescription of foods that do
not meet minimum WIC-eligibility
requirements set forth in regulations. The
States may take into account issues of cost,
nutrition, statewide availability, and
participant appeal in setting these
restrictions.
Interim rule: No change from Proposed
Rule.
Proposed rule: Ends the state practice of
categorical nutritional tailoring.
States will no longer be permitted to
construct their own standardized set of food
packages for WIC subpopulations with
common supplemental nutritional needs.
The full maximum monthly allowances of all
foods in all packages must be made available
to participants if medically or nutritionally
warranted. However, State agencies have the
authority to make adjustments to WIC foods
for administrative convenience and to control
costs. Such adjustments may involve
packaging methods, container sizes, brands,
types and physical forms of WIC foods.
Interim rule: No change from Proposed
Rule.
Proposed rule: Prohibit States from
proposing new food package substitutions.
The increased variety and choice in the
supplemental foods in the Proposed Rule is
based on IOM recommendations and the
consideration of cultural appropriate
packages for diverse groups. Therefore, WIC
State agency proposal for cultural food
substitutions will no longer be considered.
Future reviews of the WIC food packages by
FNS will be used to determine the need for
additional cultural accommodations.
Interim rule: State agencies may submit to
FNS a plan for substitution of foods to allow
for different cultural eating patterns. The
plan shall provide the State agency’s
justification, including a specific explanation
of the cultural eating pattern and other
information necessary for FNS to evaluate the
plan. FNS will evaluate a State agency’s plan
for substitution of foods for different cultural
eating patterns based on the following
criteria: (1) Any proposed substitute food
must be nutritionally equivalent or superior
to the food it is intended to replace; (2) The
proposed substitute must be widely available
to participants in the areas where the
substitute is intended to be used; and (3) The
cost of the substitute must be equivalent to
or less than the cost of the food it is intended
to replace. These criteria are the same as
those under current WIC regulations at 7 CFR
246.10(e).
Rationale: Comments requested that the
interim rule allow States the flexibility to
meet unanticipated cultural needs of
participants.
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Proposed rule: Rounding up for infant food
and infant cereal
A state agency may round up to the next
whole container for either infant formula or
infant foods (infant cereal, fruits and meats)
if needed to provide at least the maximum
authorized amount of these foods. For infant
formula, state agencies must issue the whole
containers that provide at the least the full
nutritional benefit (the maximum allowance
of reconstituted fluid ounces of liquid
concentrate) but not more than the maximum
allowance of infant formula for each food
package category and infant feeding option.
Interim rule: No change from Proposed
Rule.
69005
C. Summary of Key Provisions
The expected impact of the interim rules
on the federal government, state and local
WIC agencies, vendors, manufacturers, and
program participants is summarized in Table
1. Overall economic effects are noted with a
‘‘+$’’ for cost increases, and a ‘‘¥$’’ for cost
savings. A more detailed examination of
strictly economic effects follows Table 1.
TABLE 1.—SUMMARY OF KEY PROVISIONS
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
Current rule:
1. Food Package I serves infants from
birth through three months. Formula is
the only food prescribed under Package I.
State/local agencies
Vendors/industry
WIC participants
Reduces cost of infant
food packages. Interim packages for
four and five month
old infants (which
reduce calories
slightly) are less expensive than current
Food Package II.
Changes to current
rules will require the
implementation of
new state and local
administrative procedures.
May increase the sale
of infant formula at
the expense of juice
and infant cereal.
Provides a food package that conforms
more closely to the
diet recommended
by health professionals for four and
five month old infants.
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2. Infants from four through eleven
months are eligible for juice and infant
cereal, in addition to formula, under
Package II. The maximum formula
prescription in packages I and II are
the same.
Interim rule:
1. Expand Food Package I to serve infants up to six months. Delay the introduction of complementary foods by
two months.
2. Increase formula prescriptions at four
months to offset lost food energy.
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
¥$
Current rule:
Under Food Package I, an infant can receive up to the maximum infant formula for the package. Since the rule
does not separate partially and fully
formula fed infants, a single package
maximum applies to all partially and
fully formula-fed infants from birth
through three months. Food Package
V is provided to pregnant women and
to all new mothers, up to one year
postpartum, if they breastfeed at least
once per day. Food Package VII is
provided to fully breastfeeding mothers.
Interim rule:
Infants and mothers will be assigned
food packages based on the mother’s reported breastfeeding practice.
The corresponding amount of formula prescribed will distinguish infants less than 4 months of age as
partially breastfed or fully formulafed. The rule would provide a full
formula-feeding package to some
infants currently considered partially
breastfed; it would move some
mothers from Package V to Package VI. Partially breastfed infants
under one month of age would be
allowed to receive limited infant formula; this would move some mothers from Package VI or VII to Package V.
¥$
State/local agencies
Vendors/industry
WIC participants
If breastfeeding increases enough to
keep an infant classified as partially
breastfed who
would have been
classified as fully
formula fed otherwise, then formula
costs are reduced
and there is no
change in the mother’s status. For partially breastfed infants under one
month of age, the
low formula limit
provided during that
first month, paired
with the net effect of
mothers and infants
switching from fullyformula feeding or
fully breastfeeding
to partially
breastfeeding during
the first month may
reduce costs during
the infant’s first
month. However, a
sustained increase
in breastfeeding
during an infant’s
first year will affect
the food package
eligibility of both the
mother and the infant. Although the
economic effect of
such a sustained increase is dependent
on both
breastfeeding duration and on the relative rates of partial
and exclusive
breastfeeding, the
net economic effect
is likely to be a reduction in cost.
State and local agencies must develop
new guidelines to
implement and communicate this policy.
Negligible effect on
the sale of infant
formula for newborn
infants. But, the rule
provides an incentive to breastfeed,
which may ultimately reduce formula sales beyond
the infants’ first
month. Moving
mothers from the
fully formula fed
package to the partially or exclusively
breastfeeding packages, may slightly
increase food sales
to breastfeeding
mothers.
Although some participants may receive
less food or formula
under the interim
packages, in general, WIC infants
and mothers will
benefit from the enhanced packages
and package assignment method.
Breastfeeding education and limited
formula provided to
new mothers by
WIC staff may successfully increase
breastfeeding rates.
This is consistent
with the recommendations of
nutrition experts.
However, it is uncertain whether this
will have a significant impact on the
number of WIC
women who
breastfeed.
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Current rule:
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69007
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
The current infant food packages do not
distinguish between fully and partially
formula-fed infants. Infants receive infant formula based on an assessment
of their supplemental nutritional
needs, subject to a single package
maximum. Food Package V is provided to pregnant women and to all
new mothers, up to one year
postpartum, if they breastfeed at least
once per day and their infant receives
some formula.
pwalker on PROD1PC71 with RULES2
Interim rule:
Infants and mothers will be assigned
food packages based on the mother’s
reported breastfeeding practice. The
corresponding amount of formula prescribed will distinguish infants between partially breastfed and fully formula-fed. The rule would provide a full
formula-feeding package to some infants currently considered partially
breastfed; it would move some mothers from Package V to Package VI, or
after six months of participation, to no
package at all, depending on the
amount of formula requested.
¥$
Current rule:
Currently, the definition of breastfeeding
in WIC regulations allows women who
breastfeed once a day to be eligible
for the WIC program and receive supplemental foods.
State/local agencies
Vendors/industry
WIC participants
If the interim rule has
no direct effect on
the initiation and duration of
breastfeeding, the
cost of providing
food packages to
women will drop;
the cost of providing
infant formula will
remain unchanged.
If breastfeeding increases enough to
keep an infant classified as partially
breastfed who
would have been
classified as fully
formula fed otherwise, then formula
costs are reduced
and there is no
change in the mother’s status. Both result in cost reductions.
State and local agencies must conform
to a new definition
of breastfeeding for
WIC food package
purposes. Will also
encourage changes
in the approach to
nutrition education;
places greater emphasis on
breastfeeding promotion. Implementing new procedures will initially increase administrative burden.
Negligible effect in the
absence of changes
in breastfeeding behavior. Increased
breastfeeding would
reduce formula
sales but might
modestly increase
the sale of infant
food fruits, vegetables and meat to
WIC’s fully
breastfed population.
Although the WIC
food benefit received by women
who do not fully
breastfeed may be
reduced, in general,
WIC infants and
mothers will benefit
from the enhanced
packages and package assignment
method. The interim
packages encourage breastfeeding
consistent with the
best advice of nutrition science. However, breastfeeding
is a behavior with
many complex determinants, and it is
unlikely that the
food package
changes alone will
alter breastfeeding
practices.
These women are already counted as
participants when
they receive food
benefits as
breastfeeding
women, so the net
effect of the change
in the definition of
participation is minimal. These women
will continue to be
included in participation numbers and
State agencies will
be provided NSA
funds.
State agencies will be
provided NSA funds
for a very small
number of women
who are receiving
WIC benefits (nutrition education/
breastfeeding support and referrals to
health and social
services), but not
receiving supplemental foods.
Negligible effect because it applies only
to the few women
who breastfeed for
longer than six
months but request
the full formula fed
amount of infant formula for their infant.
These mothers
once received supplemental foods but
will no longer be eligible for these
foods. They will still
be visiting WIC approved vendors to
obtain infant formula.
Encourages more intensive
breastfeeding for
WIC women after
six months of participation.
Interim rule:
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
Revise the definition for WIC participation to include the number of
breastfeeding women who receive no
supplemental foods or food instruments but whose breastfed infant(s)
receives supplemental foods or food
instruments.
¥$
Current rule:
Infants from 4–11 months are eligible for
Food Package II. That food package
includes juice and infant cereal, as
well as formula.
pwalker on PROD1PC71 with RULES2
Interim rule:
The following changes are made to Food
Package II:
1. Change age eligibility to 6–11
months.
2. Eliminate juice.
3. Add infant food fruits and vegetables.
4. Reduce maximum formula amount.
+$
Current rule:
All infants are eligible for the same
amounts of formula, juice, and infant
cereal under Food Package II.
State/local agencies
Vendors/industry
WIC participants
The net effect of these
changes increases
the cost of Food
Package II.
Implementing new
procedures, such as
setting state policy
on allowed varieties
of infant food, will
increase short-term
administrative burden. MIS systems
will need to be revised for new foods
(infant fruits and
vegetables), quantities, and the new
age range. Need to
train WIC staff, vendors and participants on new foods.
May increase sales of
infant food and decrease sales of
juice and formula if
participants were
not already using
the quantities in the
interim rule. Some
vendors may need
to stock additional
infant food varieties
that meet the specific specifications
set by the states.
Vendors will need to
train personnel to
identify the newly
WIC-eligible infant
foods.
Restructures the infant
package according
to the recommendations of current nutrition science. Increases benefits by
adding fruits and
vegetables, but decreases maximum
allowance of infant
formula and eliminates juice. Encourages good infant
feeding practices
and the consumption of fruits and
vegetables.
The cost of the fully
breastfed package
for infants age six
months and older is
increased significantly.
Implementing new
procedures, such as
setting state rules
on permissible varieties of infant food
meat, will increase
short-term administrative burden. Need
to train WIC staff,
vendors and participants on new foods.
MIS systems will
need to be revised.
Increase in sales of
infant food meat is
likely to be negligible. The number
of fully breastfed
WIC infants age six
months and over is
small. Vendors will
need to train personnel to identify
the newly WIC-eligible infant foods and
distinguish them
from similarly packaged ineligible
items.
Provides added iron
and zinc to the diet
of fully breastfed infants age six
months and older.
Also encourages
breastfeeding by increasing benefits.
Both are consistent
with the recommendations of
current nutrition
science.
Interim rule:
Provide relatively more infant food fruit
and vegetables to fully breastfed infants at six months than to partially
breastfed or fully formula-fed infants.
Also provide infant food meat to this
group.
+$
Current rule:
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69009
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
1. Low iron infant formula may be prescribed with medical documentation.
2. Infant cereal must be iron-fortified;
WIC regulations contain no other
specifications.
Interim rule:
1. Disallow the prescription of low iron
infant formula.
2. Disallow the prescription of infant cereal with added ingredients.
(minimal economic effect)
Current rule:
Children and women with special dietary
needs are prescribed WIC-eligible
medical foods under Food Package
III. Infants with special dietary needs
are provided exempt infant formula
under Food Packages I or II.
pwalker on PROD1PC71 with RULES2
Interim rule:
Serve infants with special dietary needs
who receive exempt infant formulas
under Food Package III.
¥$
Current rule:
Current practice allows some women
and children with certain dietary restrictions, but without serious medical
conditions, to be prescribed medical
foods under Food Package III.
State/local agencies
Vendors/industry
WIC participants
These changes are
expected to have little effect on the
foods actually prescribed to WIC infants. The infant cereal rule simply formalizes what has
been federal policy
since 1980.
The states will incur
minimal short-term
administrative burden as they implement these minor
rule changes. Local
WIC agencies will
need to communicate the ‘‘no low
iron infant formula
from WIC’’ concept
to the local medical
community and
some participants.
MIS systems will
need to be revised.
Sales of low iron formula and certain infant cereal varieties
will be reduced
slightly, if at all, by
these rules.
The very few WIC
participants who
have been receiving
low iron formula
from WIC will either
need to purchase
the product or work
with their medical
provider to change
to an iron fortified
infant formula authorized by WIC.
The rule is intended to
reduce administrative costs and facilitate program management.
The rule is intended to
facilitate program
management. It
may also allow improved service to
WIC beneficiaries.
MIS systems will
need to be revised.
No impact.
No direct impact. Improved service at
the state and local
level may result, to
the benefit of WIC
participants.
Clarifies who is eligible for Food Package III and what
foods may be distributed as part of
that package. These
clarifications are
generally aimed at
tightening these criteria. Will, if anything, reduce Package III costs by
moving some participants to food
packages more appropriate for their
needs. But, given
the size of the current Package III
population (roughly
1% of all WIC participants) these savings will be small.
The rule may reduce
administrative burden by eliminating
Package III eligibility
issues. But, it may
require state efforts
to educate local
WIC officials, WIC
participants, and
health care professionals on the eligibility criteria.
Possible minimal reduction in the sale
of medical foods
due to eligibility requirements.
Some current participants receiving
Package III may be
served under food
packages more appropriate to their
needs.
Interim rule:
Clarify language governing the purpose
and scope of Package III eligibility.
¥$
Current rule:
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
Package III recipients are prescribed
medical foods only; they do not receive any of the standard food package foods.
Interim rule:
Make other WIC foods available to
Package III recipients.
+$
Current rule:
Food Packages IV through VII provide
WIC beneficiaries with 24 to 28 quarts
of milk per month. Cheese may be
substituted for milk at a rate of one
pound per three quarts; cheese may
replace a total of 12 quarts of milk.
State/local agencies
Vendors/industry
WIC participants
This rule will increase
costs in those cases
where Food Package III recipients
are able to consume the foods
contained in the
regular WIC food
packages to which
they would otherwise be eligible.
But, the Package III
population is small.
The costs will be
modest.
Administrative burden
of implementing the
new rule will be incurred in the short
run. Local agencies
will need to determine which WIC
foods can be purchased to each
Food Package III
recipient. MIS systems will need to be
revised.
May have a small
positive effect on
the sale of some
secondary WIC
foods. Will not affect
sales of infant formula.
For those Package III
recipients able to
consume at least
some non-Package
III WIC foods, this
rule will provide
them with additional
food.
The net effect of this
provision will be a
reduction in overall
cost, due to the reduction in quantities
allowed and reduced substitution
amounts.
The states will need to
establish new specifications and restrictions for the new
milk substitutes.
They will also incur
administrative burden in implementing
changes to reflect
reduced milk prescription maximums
and substitution limits. Local agencies
will need to educate
WIC vendors and
participants on new
food items. MIS
systems will need to
be revised.
The rule may result in
reduced milk and
cheese sales to
WIC participants. It
may lead to increased sales of
tofu and soy beverage. Vendors may
need to stock new
items that match the
specific product requirements set by
the states. Rule proposes nutritional
standards for soy
milk that are currently not met by
many products on
the market. Because these standards will also apply
to the school meals
programs, vendors
are likely to change
fortification so that
the variety of available soy beverages
that can be authorized improves over
time.
Reduces dairy component of WIC benefit.
WIC participants
who are unable to
drink milk may benefit most by the addition of these new
substitutes. Others
with individual or
cultural preferences
will also benefit by
the added choices.
All WIC participants
will benefit from a
package lower in
saturated and total
fat, consistent with
the recommendations of current nutrition science.
pwalker on PROD1PC71 with RULES2
Interim 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:
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
69011
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
Juice may be prescribed under Food
Packages IV through VII at maximum
levels that range from 192 to 336 fl.
oz. per month.
Interim rule:
Reduce maximum juice prescription
amounts in food packages for children
and women. Add a voucher for fruits
and vegetables (other than white potatoes) to those packages.
+$
Current rule:
Eggs are provided under Food Packages IV through VII. States may set
their monthly maximums at either 2 or
21⁄2 dozen per month.
State/local agencies
Vendors/industry
WIC participants
The fixed dollar values
of the fruit and vegetable vouchers in
the interim rule are
greater than the offsetting savings that
will be realized
through reduced
juice amounts.
States will need to authorize and develop
a structure to distribute and redeem
fruit and vegetable
vouchers, which will
be a new component of the programs. This administrative burden will
be on-going but part
of the current banking and MIS systems. State and
local agencies will
incur administrative
burden in developing educational
messages for WIC
participants concerning the selection of nutritious
fruits and vegetables. Need to train
WIC staff, vendors
and participants on
new food amounts.
MIS systems will
need to be revised.
Juice sales to WIC
participants may decline. Sales of fruits
and vegetables may
increase. Costs will
be incurred by vendors as they learn
to accommodate the
new WIC vouchers.
Some WIC authorized vendors may
need to add fruits
and vegetables to
their stocks in fresh,
frozen, or canned
form. Emphasis on
fresh fruits and
vegetables may encourage states to
authorize and participants to shop at
farmers markets
more often. (See
Market Analysis discussion in Section
G).
Expands WIC benefits
by adding fruits and
vegetables, while
reducing juice
amounts. The addition of fruits and
vegetables to the
WIC food packages
responds to the recommendations of
nutrition science.
And the flexibility of
a voucher will provide access to a variety of fruits and
vegetables, in some
form, year round, in
all markets.
Reducing the maximum egg prescription will produce a
modest reduction in
food package costs.
That reduction is
used to help offset
costs of new foods
and substitution options.
State and local administrative burden will
be incurred in the
short term as new
procedures are put
in place. Local
agencies will need
to educate WIC
vendors and participants on new food
amounts. MIS systems will need to be
revised.
Sales of eggs to WIC
participants will decline. Market effects
will be minimal.
This change reduces
food energy, cholesterol, and fat content of the WIC food
packages. The
changes are consistent with the advice of current nutrition science. The
reduction in food
energy also makes
room for the introduction of new
foods that address
priority nutrient
needs.
pwalker on PROD1PC71 with RULES2
Interim rule:
1. Reduce maximum egg prescription in
all food packages for women and children.
¥$
Current rule:
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69012
Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
There are no restrictions on the fat content allowed in milk.
pwalker on PROD1PC71 with RULES2
Interim rule:
1. Provide only fat reduced milk to
women as well as children age two
and older.
2. Provide only whole milk to children
one year of age.
¥$
Current rule:
Grains are included in the current food
packages for women and children in
the form of breakfast cereal. Current
regulations do not specify a minimum
whole grain content for that product.
State/local agencies
Vendors/industry
WIC participants
Prescribing only fat reduced milk to
women and children
age two and older
will have a negligible effect on
cost.
State and local administrative burden will
be incurred in the
short term as new
procedures are put
in place. Local
agencies will need
to educate WIC
vendors and participants on new food
amounts. MIS systems will need to be
revised.
Market effects will be
minimal. Vendors
will need to train
personnel to allow
the type of milk
specified on the
food instruments.
This proposal reduces
total fat and saturated fat content of
the WIC food packages. The change is
consistent with the
advice of current
nutrition science.
The addition of whole
grain bread to Packages IV, V, and VII
increases the cost
of those packages.
The requirement for
50 percent of available cereals for children and women to
be classified as
whole grain will
have a minor effect
on cost.
State and local agencies will incur administrative burden
to implement the
new rules. States
will incur administrative burden in establishing specifications and restrictions for the new
foods and substitution options and
local clinics will
incur additional administrative burden
to explain food options to participants.
Local agencies will
need to educate
WIC vendors and
participants on new
food amounts and
how to distinguish
them from similarly
packaged ineligible
items. MIS systems
will need to be revised.
Manufacturers may respond by reformulating popular WICapproved cereals in
whole grain form.
Smaller vendors
may need to modify
stocks to include
whole grain bread
varieties and at
least one whole
grain cereal. All
vendors will need to
train personnel to
readily identify WICeligible breads and
grains.
WIC participants will
benefit from food
packaged enhanced
with whole grain cereals and food products. The addition of
whole grains to the
WIC packages is
consistent with 2005
Dietary Guidelines
for Americans that
encourage increased consumption of these foods.
Interim rule:
1. Add whole grain bread to Food Packages IV, V, and VII. Allow substitutions of other whole grain foods for
bread.
2. Require that at least 50 percent of
breakfast cereals on State agency
food lists must have whole grain as
the primary ingredient and meet FDA
labeling requirements for making a
health claim as whole grain food of
moderate fat content.23 State agencies must require vendors to stock at
least one whole grain cereal.
+$
Current rule:
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69013
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
Dry beans are included in Food Packages IV, V, and VII. Canned beans
may be prescribed, instead of dry, to
WIC participants who lack cooking facilities.
Interim rule:
1. Allow canned beans as a substitute
for dry in all food packages for children and women.
2. Allow both Package V and Package
VII recipients to replace both their dry
bean and peanut butter allocations
with canned beans.
+$
Current rule:
Beans and peanut butter are not included in Food Package VI. Package
V currently provides a pound of dry
beans; those can be replaced with
18oz of peanut butter.
pwalker on PROD1PC71 with RULES2
Interim rule:
1. Add one pound of beans, with an
18oz 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 18oz of
peanut butter.
+$
Current rule:
26 oz of tuna is made available to exclusively breastfeeding women in Food
Package VII. White, light, or dark
tuna, packed in water or oil, is allowed.
State/local agencies
Vendors/industry
WIC participants
The rate of substitution between
canned and dry
beans in the interim
rule will increase
costs. However, the
cost of beans in the
food packages is
relatively small and
this change will
have a relatively
modest effect on
overall program
cost.
The option in the interim rule will
prompt states to set
specifications and
restrictions. Other
short-term administrative burden will
be incurred as the
new rule is put in
place. Local agencies will need to
educate WIC vendors and participants on new food
amounts. MIS systems will need to be
revised.
Market effects will be
minimal. But, as
with the addition of
any WIC substitution option, small
vendors may need
to add new items to
their stocks, and all
vendors will need to
train personnel to
identify the newlyeligible WIC foods.
By adding variety and
convenience, the
canned bean option
should increase the
appeal of that food.
It may also encourage greater consumption, replacing
less healthy foods
in the diets of WIC
participants.
The costs of food
packages V and VI
are increased.
Neither of these
changes introduces
foods not already
included in other
WIC packages.
Local agencies will
need to educate
WIC vendors and
participants on new
food amounts. MIS
systems will need to
be revised.
Minimal market impact.
The addition of beans
and peanut butter
increases benefits
to WIC participants.
These changes supplement the diets of
breastfeeding and
postpartum women
with several of the
priority nutrients
identified by the
IOM.
Costs will increase
slightly. While the
new substitution option may increase
the cost of individual prescriptions,
the number of WIC
participants eligible
for Food Package
VII is very small.
States and local agencies will incur administrative burden
in implementation.
State agencies will
adopt specifications
and restrictions for
the new substitution
option. Local agencies will need to
educate WIC vendors and participants on new food
amounts. MIS systems will need to be
revised.
Minimal market impact. But, may force
small vendors to
stock additional
types of canned fish
and will require all
vendors to train personnel to identify
newly-eligible WIC
foods.
These changes add
new choices that
may encourage
consumption. The
rule also responds
to medical advice
that breastfeeding
women avoid fish
species that are
high in mercury.
Interim rule:
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69014
Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
Authorize a variety of canned fish that
do not pose a mercury hazard to fully
breastfeeding women. Slightly increase the maximum amount allowed
to 30 ounces.
+$
Current rule:
State WIC agencies impose restrictions
on some foods by brand or variety in
order to limit cost or ensure statewide
product availability. The practice is accepted but not formally authorized by
regulation.
Interim rule:
Clarifies the right of States to restrict
WIC foods by variety or brand.
(minimal economic impact)
Current rule:
States are permitted to prescribe foods
to WIC participants in quantities that
are less than the package maximums
when nutritionally warranted. States
may also standardize these reductions
and apply the reduced amounts consistently to like groups of WIC participants. Such categorical food package
tailoring may be done for nutritional
reasons, but not to achieve cost reductions.
State/local agencies
Vendors/industry
WIC participants
This simply clarifies
what is already accepted policy. The
policy is an effective
way to control
costs. Since the rule
represents no
change from current
practice, it results in
no economic impact.
States are given formal approval for
current practice.
States should incur
little or no administrative burden in implementation.
If States adopt restrictions on the brands
or varieties of foods
newly added to the
WIC food packages,
then participants
who already purchase those foods
may switch their selection of brands or
varieties to the
WIC-approved
choices. A measurable shift in consumption by brand
or variety may result.
WIC participants may
need to switch
brands or varieties
of foods that they
currently consume
to brands and varieties consistent with
those added to the
WIC packages.
Assures more consistent WIC benefits
are delivered across
States.
The rule reduces the
level of work currently undertaken by
State officials. Administrative burden
will decrease to the
extent that states
will not undertake
their own review of
WIC prescription
maximums in response to the federal revisions to the
WIC food packages.
In the absence of
this rule, States
may have incurred
administrative burden.
Minimal effect on vendors and producers.
Assures more consistent WIC benefits
are delivered across
States. IOM has
based food prescription quantities
on current nutritional science rendering food package
tailoring unnecessary.
pwalker on PROD1PC71 with RULES2
Interim rule:
Ends the practice of categorical tailoring
of WIC food packages by States.
¥$
Interim rule:
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
69015
TABLE 1.—SUMMARY OF KEY PROVISIONS—Continued
Effect of interim rule on:
Current and interim rules:
USDA/Federal gov’t
Allow State agencies to round up to the
next whole container of infant foods if
needed to provide the maximum authorized amount of these foods.
+$
Interim rule:
Allow State agencies to propose plans
for additional package substitutions to
meet unanticipated cultural needs of
participants. State agencies will only
substitute foods after receiving written
approval from FNS.
D. Costs
1. Interim Rule
Under the interim rule, FNS estimates that
the revisions to the WIC food packages will
be cost-neutral. FNS estimates that the
State/local agencies
Vendors/industry
WIC participants
Minimal cost given the
small container
sizes involved.
Rounding up is likely to require the addition of little jarred
infant food to the
food packages; containers are typically
just 4oz. The current infant cereal
maximum of 24oz is
a multiple of a commonly prescribed
package size; 8oz
boxes are among
the standard package sizes.
States may incur
some administrative
burden to implement, particularly if
manufacturers
change container
sizes in response to
this rule. Local
agencies will need
to educate WIC
vendors and participants on rounded
formula amounts.
MIS systems will
need to be revised.
Unless manufacturers
change container
sizes to achieve
greater product
sales, no impact is
expected.
Will ensure WIC participants get the full
nutritional benefit
authorized.
Will increase administrative costs of considering proposals
but little effect on
program costs since
very few package
substitutions have
ever been approved.
Because of the interim
rule’s flexibility in
food offerings,
States will no longer
have as much, if
any, need to request substitutions
to meet cultural
preferences. Administrative savings will
accrue for those
States that do not
pursue substitutions.
Minimal since very
few food package
substitutions have
ever been permitted.
Minimal since very
few food package
substitutions have
ever been permitted.
changes will decrease costs by $29.7 million
over five years.
The economic effects of the interim rule on
the federal government over a five-year
period are summarized in Table 2, which
presents the impacts of the revisions by food
package type. These figures are limited to
food costs; no additional funds will be
provided to States or local clinics to
implement this rule. The costs have been
adjusted for the rule’s phasedimplementation schedule. Current and
interim food package costs are provided in
Tables A1-A3 in Appendix A.
TABLE 2.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS
[in millions]
Food package
FY 2008
I—Infants (0–5.9 months) ................................................
II—Infants (6–11.9 months) .............................................
III—Participants with qualifying conditions ......................
IV—Children (1–4.9 years) ..............................................
V—Pregnant and Partially Breastfeeding Women ..........
VI—Postpartum Women ..................................................
VII—Exclusively Breastfeeding Women ..........................
Total ..........................................................................
¥$12.6
23.9
3.0
¥18.4
6.5
0.5
2.1
5.0
FY 2009
FY 2010
¥$44.4
84.2
10.6
¥71.0
20.8
0.4
6.7
7.3
¥$53.4
101.2
12.8
¥92.0
22.6
¥0.9
7.2
¥2.5
FY 2011
¥$55.8
105.8
13.4
¥102.7
21.2
¥2.3
6.7
¥13.9
FY 2012
¥$58.3
110.4
14.0
¥113.8
19.7
¥3.8
6.1
¥25.6
pwalker on PROD1PC71 with RULES2
Negative values are cost reductions. Column and row totals may not be exact due to rounding. FY08 begins with December 2007.
2. Major Cost Drivers
Table 3 shows the major cost drivers for
each food package; provisions listed do not
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FY 2008–
FY 2012
¥$224.5
425.4
53.8
¥398.0
90.9
¥6.3
28.9
¥29.7
69016
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TABLE 3.—MAJOR COST DRIVERS OF WIC FOOD PACKAGES
Food package
Major cost drivers (2008–2012)
I ..........................
II .........................
• Formula is reduced for partially breastfed infants and eliminated for fully breastfed infants (¥$172 million post rebate).
• Formula is reduced for fully formula and partially breastfed infants and is eliminated for fully breastfed infants (¥$516 million post rebate).
• Juice is eliminated for all infants (¥$163 million).
• Infant fruits and vegetables are added along with infant meats for fully breastfed infants (+$1,117 million).
Package III recipients are eligible for foods in the other packages. Under the interim rule, nearly 76% of Package III recipients are infants, and 24% are children; fewer than 1% are women. (+$62 million).
• Juice is reduced (¥$930 million).
• Milk is reduced (¥$895 million),
• Cheese is reduced (¥$559 million).
• Eggs are reduced (¥$215 million).
• Whole grains added (+ $703 million).
• $6 cash-value instrument for fruits and vegetables is added (+ $1,314 million).
• Juice is reduced (¥$305 million).
• Cheese is reduced (¥$219 million).
• Milk is reduced (¥$219 million).
• Beans are increased (+$113 million).
• Milk substitutions are added (soy beverage and tofu) (+$180 million).
• $8 cash-value instrument for fruits and vegetables is added (+$486 million).
• Milk is reduced (¥$166 million).
• Juice is reduced (¥$124 million).
• Cheese is reduced (¥$99 million).
• $8 cash-value instrument for fruits and vegetables is added (+$272 million).
• Juice is reduced (¥$124 million).
• Milk is reduced (¥$75 million).
• $10 cash-value instrument for fruits and vegetables is added (+$175 million).
III ........................
IV .......................
V ........................
VI .......................
VII ......................
Negative values (¥) are cost reductions, positive values (+) are cost increases. There are a total of $581 million in increases and $239 million
in decreases that are not reflected in this table.
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3. Fruit and Vegetable Option
Due to the seasonal fluctuation in price
and availability of fresh fruits and vegetables,
and the inability to purchase them in
uniform weight units, it is difficult to set
quantity terms for fruits and vegetables and
still estimate the cost of the WIC food
packages. In order to accurately capture the
cost of providing fresh fruits and vegetables
in WIC Food Packages III-VII, the interim rule
includes fruit and vegetable vouchers. Due to
the administrative ease of implementation,
the IOM recommended cash-value
instruments be issued.24 The IOM also
recommended that states provide fruit and
vegetable vouchers at the level of $10 per
month for women and $8 per month for
children. However, to achieve cost neutrality
with the changes, FNS set the vouchers at the
level of $8 per month for pregnant, partially
breastfeeding and postpartum women and $6
per month for children in the year in which
the food package revisions take effect. Fully
breastfeeding women receive the
recommended $10 voucher as part of WIC’s
breastfeeding promotion initiatives. Vouchers
will be adjusted for inflation. The effects of
inflation will be accrued annually, but not
realized until the cumulative increase in the
CPI is sufficient to raise the voucher’s value
by a dollar. Inflation is measured as the
change in the Consumer Price Index (CPI) for
fresh fruits and vegetables, as detailed in the
interim rule.
4. Cost Estimate Methodology
Overview
The impacts of the interim rule on Federal
expenditures are projected by comparing
24 IOM,
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current policy to the interim rule with regard
to total food costs. (Administrative funds are
excluded; as noted above, no increase in
funds will be provided to States or local
clinics to implement this rule.)
For both current and new rules, food costs
are calculated as the sum of the aggregate
annual expenditures on each available food
package. These expenditures are calculated
separately as the product of:
• Participants—the number of women,
infants, and children who receive each WIC
food package;
• Food Prescriptions—the specific types
and quantities of food contained in each
package distributed to WIC participants; and
• Food Prices—the cost of the food items
contained in WIC food packages.
The data sources and assumptions used in
projecting each of these elements are
summarized briefly here. Greater detail is
provided on the pages that follow.
i. Participation—Participation statistics are
remitted by State WIC agencies to FNS on a
monthly basis. These are the product of
routine recordkeeping by WIC clinics. They
include counts of the number of women,
infants, and children who receive WIC
services. FNS collects additional programrelevant participant demographic
characteristics such as age and life stage data
through biennial data collections from WIC
State agencies, as well as supplemental data
on current breastfeeding practice.
Participants are distributed as recipients of
specific food packages under the current and
new rules. Growth in program participation
is based on projection of historical
participation figures alone.
ii. Prescriptions—FNS gathers detailed
information on the amount of food prescribed
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to individual WIC participants through the
same survey of WIC providers that serves as
FNS’s source for participant demographics.
FNS uses these current prescription records,
plus a set of explicit assumptions about
participant preferences, to generate
prescription totals for each of the foods in the
interim rule’s revised packages.
iii. Prices—FNS tabulated average prices
for each of the foods contained in the current
and revised food packages from AC Nielsen’s
calendar year 2005 Homescan dataset. The
final prices used in the cost estimate are
these tabulated figures, adjusted for inflation
and for rebates negotiated with infant
formula manufacturers.
FNS has posted these participation,
prescription, and price figures on its Web site
(https://www.fns.usda.gov), in Microsoft Excel
format. Separate figures are given for each of
the current and proposed food packages, and
for each of the five fiscal years 2008 through
2012.
The posted data will permit interested
parties to reproduce the results of the cost
estimate presented here. FNS encourages
interested parties to examine the spreadsheet
after reading the more detailed methodology
that follows.25
a. Food Package Costs
i. Prescriptions
FNS’s primary data source for participant
prescription data is its 2002 WIC Participant
and Program Characteristics (‘‘PC2002’’)
dataset. PC2002 is the eighth in a series of
biennial reports and datasets on WIC
25 Additional information on the posted data, or
on any other aspect of this cost estimate, is
available from FNS on request.
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participant and program characteristics.
PC2002 employs the reporting system
developed by FNS in 1992, which compiles
key features of WIC participant information
from State WIC agencies. The current system
for reporting participant data is based on the
automated transfer of an agreed upon set of
data elements held in State management
information systems. As part of the
documentation needed to process the WIC PC
participant data, each State also provides a
food package code list which shows types
and amounts of WIC food prescribed along
with the State coding scheme.
PC2002 summarizes demographic
characteristics of WIC participants
nationwide as of April 2002, along with
information on participant income and
nutrition risk characteristics. PC2002
contains information on a near-census of WIC
enrollees for whom food benefits were made
available in WIC management information
systems in April 2002.26 The dataset and the
report’s tabulations are based on over 8
million records.27
FNS used prescription data from the
PC2002 dataset to establish a baseline food
cost and to estimate the costs of the package
revisions. Actual participant-level
prescriptions provide a useful starting point
for this analysis. Data at the participant level
captures the preferences and dietary
restrictions of the current WIC population.
Assuming little change in the distribution of
the WIC population by life stage, food
preference, or supplemental dietary need
over the short term, the 2002 prescription
data offers the best opportunity for estimating
likely prescription amounts under the
interim food package rule.28 FNS estimated
participant-specific prescription amounts for
each of the foods in the packages other than
infant formula. In an effort to reflect the
interim rule’s requirements that (1)
participants be issued prescriptions at the
maximum level per package, unless that level
for one or more items is medically
contraindicated, or the participant declines
to accept the item; and (2) States may no
longer adjust or ‘‘tailor’’ packages
categorically, but that WIC professionals may
do so, the following assumptions guided this
analysis: 29
• For foods that are part of both the current
WIC packages and the revised packages:
• WIC participants currently prescribed
none of that food will continue to be
prescribed none (presumed medically
contraindicated).
• If the participant’s current prescription
exceeds the interim rule’s maximum for the
item, then the participant will be prescribed
the new maximum amount.
• If the participant’s current prescription is
less than the maximum amount allowed by
the state under current rules, and less than
the interim rule’s amount, then the
participant’s prescription will remain
unchanged.
• For foods newly added to the WIC
packages by the interim rule:
• Generally, prescription rates are set to
observed rates for comparable foods already
contained in the WIC packages.30
• Foods newly added to the WIC packages
as substitutes for standard WIC foods were
prescribed to a subset of the WIC population
equal to the percent of all low income U.S.
households that currently purchase those
items.31 For example, market consumption
data indicates that about 3% of U.S.
households with WIC-eligible incomes
purchased tofu, so 3% of WIC participants
are assumed to be prescribed tofu.32
Participants prescribed one of the new
substitutes will be provided with the
maximum required under the interim rule
given any other substitutions allowed.
• Fruit and vegetable vouchers are
assumed to be prescribed to all participants
at the full amount.
This methodology tends to produce
prescription estimates that are at or near the
maximum quantities specified in the revised
packages. (See Table 4.)
ii. Infant Formula and Rounding
In this analysis, infant formula and infant
foods were treated slightly differently than
the other foods. Using a micro-simulation
program with PC2002 data to model
prescription amounts for infant formula and
foods would not account for ‘‘rounding up’’.
Rounding up refers to the ability of state
agencies to round up to the next whole
container to provide the maximum infant
formula allowance. State agencies may only
include an option to round-up in infant
formula contracts renewed on or after
October 1, 2004. The interim rule extends
this rounding option to infant foods (cereal,
fruit and vegetables, and meat).
Since the PC2002 data do not reflect the
costs of states rounding up, the cost estimates
of the current and interim rule packages use
a different approach to factor in the cost of
states rounding up. Given current container
sizes, rounding up is only required when
26 For the month of April 2002, each State WIC
agency was required to submit MDS data on a
census of its WIC participants. All but 4 of the
eighty-eight State WIC agencies (Mississippi,
Choctaw Nation (OK), Eastern Shoshone and
Rosebud Sioux) were able to provide sufficient data
for tabulation in PC2002.
27 Fewer participants—approximately 7.5
million—actually picked up their vouchers in April
2002 and were counted according to WIC
regulations as participants for WIC administrative
funding purposes.
28 Due to insignificant differences in the PC2002
and PC2004 data, this analysis was not updated
with the PC2004 dataset.
29 The description that follows is a simplification
of the process used to develop the estimated
prescriptions.
30 For example, the prescription rates for whole
grain bread and bread substitutes are set to the
observed prescription rates for cereal. The April
2002 Food Package IV cereal prescription rate was
applied to Package IV bread prescriptions; the
average Package V and Package VII cereal
prescription rate was used to estimate Package V
and Package VII bread prescriptions.
31 Market consumption data is based on 2003 AC
Nielsen Homescan survey data.
32 This method of identifying general consumer
preferences for particular items cannot be used to
estimate the share of the infant population that
consumes fresh bananas. It is assumed, then, that
infants will be prescribed bananas as a substitute
for jarred infant food fruits and vegetables at the
average prescription rate for all foods across all food
packages.
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69017
issuing powder infant formula and infant
fruit and vegetables. The maximum
allowances for liquid concentrate infant
formula, ready-to-feed infant formula, infant
cereal and infant meat are evenly divisible by
whole containers. To capture the effect of
rounding, the following assumptions have
been made:
• Current Food Packages I and II
• Estimated infant formula prescription
amounts for Packages I and II incorporate
rounding because the estimated reconstituted
amounts fall below the package maximum.
Estimated prescribed amounts for Packages I
and II are set at the maximum amounts of 806
reconstituted liquid ounces for liquid
concentrate and ready to feed infant
formulas; for powder infant formula the
current 8 pound limit is used.
• The reconstituted fluid ounces from
powder infant formula is a weighted average
of the powder container yield for the three
infant formula brands with which state
agencies have rebate contracts: Mead
Johnson, Ross and Nestle (as determined by
State agency contracts as of February
2007.) 33
• Total infant formula allowance for each
package is weighted by the percentage of
infants receiving each of the three forms
(liquid concentrate, ready to feed, and
powder) as distributed in the WIC participant
characteristic data set.
• Interim Food Packages I and II
• Infant Formula:
• All packages are set at the maximum
monthly allowance for liquid concentrate,
ready to feed and powder infant formulas as
detailed in the interim rule.
• Powder infant formula is rounded up to
meet the Full Nutritional Benefit (the
maximum monthly allowance of
reconstituted liquid concentrate), but to not
exceed the maximum monthly powder infant
formula limit.
• The reconstituted fluid ounces from
powder infant formula is a weighted average
of the powder container yield for the three
formula brands with which state agencies
have rebate contracts: Mead Johnson, Ross
and Nestle (as determined by state agency
contracts as of February 2007). 34
• Interim Food Package I BF/FF–A
assumes 100 percent powder infant formula.
This is consistent with IOM
recommendations.
• Total infant formula allowance for each
package is weighted by the percentage of
infants receiving each of the three forms
(liquid concentrate, ready to feed, and
powder) as distributed in the WIC participant
characteristic data set.
• Infant Foods:
• Only Package II has infant foods.
Container sizes are based on IOM
assumptions: infant fruits and vegetables
amounts are determined using Gerber
33 The primary DHA/ARA enhanced powder
formulas prescribed by WIC clinics for each of the
manufacturers was used in computing the weighted
average.
34 The primary DHA/ARA enhanced powder
formulas prescribed by WIC clinics for each of the
manufacturers was used in computing the weighted
average.
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
container sizes weighted over the 6 month
package period.35
• Bananas are allowed to be substituted for
infant fruit at the rate of 2 pounds per 16
ounces of fruit. The interim package cost
estimate assumes 1.8 pounds of bananas as
substitution.
The interim rule requires State agencies to
issue at least the full nutritional benefit of
infant formula but not more than the
maximum monthly allowance for the food
package category and infant feeding option.
However, rounding up to the whole container
to meet the full nutritional benefit under the
interim rule, when compared to the
maximum monthly allowance under the
current rule, provides more containers per
month, which in turn results in higher costs.
In addition, under both the current and
interim packages, the round up provision is
assumed to apply in all States at full
implementation beginning in FY08.
Therefore, this analysis provides the most
conservative estimate of the additional cost
due to rounding (assuming container sizes do
not change), as there is no way to accurately
determine which States will elect to include
a round up provision in their infant formula
rebate contract and opt to round up going
forward.
iii. Redemption rates
Tables 4 and 5 show the maximum amount
per food category and estimated average
prescribed amounts used to calculate costs
for the food packages under the interim rule
and under the current rule, respectively.
Each table includes the individual food
package component and its corresponding
unit of measurement.
WIC foods are provided by quantity, except
for the fruit and vegetable voucher. As stated
in the interim rule, participants will be given
a fruit and vegetable voucher with a fixed
dollar value which can be used to purchase
fruit and vegetables. Because the fruit and
vegetable voucher provides WIC benefits in
a different form than is currently used,
different redemption behavior is to be
expected. Therefore, in developing a cost
estimate for the rule, it is assumed that these
vouchers will be redeemed at a rate of 87.5
percent, which is consistent with an
evaluation of a WIC fruit and vegetable
intervention in Los Angeles in 2004.36 Per
participant, a redemption value of $5.25 for
children, $7.00 for pregnant, partially
breastfeeding and postpartum women, and
$8.75 for fully breastfeeding women was
included in the cost of the respective food
package.
All other WIC foods are assumed to be
redeemed at a 100% rate. The assumption of
100% redemption rates for other WIC foods
reflects research findings which indicate that
redemption rates for current WIC foods are
high and vary little by food item (ranging
from 94–99 percent).37 Variation in the
quantity of foods purchased by participants
is reflected in the prescription rates. Thus a
simplifying assumption of 100 percent
redemption rates was used for WIC foods
prescribed by quantity.
TABLE 4.—PRESCRIPTION ESTIMATES UNDER INTERIM RULE 38
Maximum
amount per
food category 40
Units 39
Food package
Estimated
average
prescribed
amount
Infants: Food Package I
I–FF–A (0–3.9 mo):
Formula (post-rebate) ...........................................
I–FF–B (4–5.9 mo):
Formula (post-rebate) ...........................................
I–BF/FF–A (0–0.9 mo):
Formula (post-rebate)41 ........................................
I–BF/FF–B (1–3.9 mo):
Formula (post-rebate) ...........................................
I–BF/FF–C (4–5.9 mo):
Formula (post-rebate) ...........................................
I–BF–A (0–3.9 mo):
Formula (post-rebate) ...........................................
I–BF–B (4–5.9 mo):
Formula (post-rebate) ...........................................
reconstituted fluid oz ...................................................
806
842.65
reconstituted fluid oz ...................................................
884
931.37
reconstituted fluid oz ...................................................
104
0.00
reconstituted fluid oz ...................................................
364
390.14
reconstituted fluid oz ...................................................
442
470.66
reconstituted fluid oz ...................................................
0
0.00
reconstituted fluid oz ...................................................
0
0.00
Infants: Food Package II
II–FF (6–11.9 mo):
Formula (post-rebate) ...........................................
Cereal ....................................................................
Baby fruits & vegetables .......................................
Bananas .........................................................
II–BF/FF (6–11.9 mo):
Formula (post-rebate) ...........................................
Cereal ....................................................................
Baby fruits & vegetables .......................................
Bananas .........................................................
II–BF (6–11.9 mo):
Cereal ....................................................................
Baby fruits & vegetables .......................................
Bananas .........................................................
Infant food meat ....................................................
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
lb .................................................................................
624
24
128
..........................
656.66
20.10
105.37
1.80
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
lb .................................................................................
312
24
128
..........................
355.32
20.93
105.37
1.80
oz ................................................................................
oz ................................................................................
lb .................................................................................
oz ................................................................................
24
256
..........................
77.5
22.27
225.03
1.80
73.06
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Children: Food Package IV
IV–A (1–1.9 yrs):
Juice ......................................................................
35 The prescription rates for infant cereal, fruit
and vegetables, and meat are set to the average
prescription rate of juice across all of the women’s
food packages. The estimate assumes that no state
will authorize rounding of infant foods.
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oz ................................................................................
36 Herman, Dena and Harrison, Gail, ‘‘Are
Economic Incentives Useful for Improving Dietary
Quality among WIC participants and their
Families?’’ ERS, USDA, 2004.
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128
127.59
37 Food and Nutrition Service, U.S. Department of
Agriculture, ‘‘National Survey of WIC Participants’’,
October 2001.
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
69019
TABLE 4.—PRESCRIPTION ESTIMATES UNDER INTERIM RULE 38—Continued
Estimated
average
prescribed
amount
Food package
Units 39
Maximum
amount per
food category 40
Milk (whole) ...........................................................
Cheese ...........................................................
Cereal ....................................................................
Eggs ......................................................................
Whole grain bread .................................................
Other grains ...................................................
Beans, dried 42 ......................................................
Beans, canned ...............................................
Peanut butter .................................................
Fruit and vegetable voucher.43 .............................
IV–B (2–4.9 yrs):
Juice ......................................................................
Milk, fat-reduced ....................................................
Cheese ...........................................................
Cereal ....................................................................
Eggs ......................................................................
Whole grain bread .................................................
Other grains ...................................................
Beans, dried ..........................................................
Beans, canned ...............................................
Peanut butter .................................................
Fruit and vegetable voucher.43 .............................
qt .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
oz ................................................................................
voucher ($) ..................................................................
16
..........................
36
1
2
..........................
1
..........................
..........................
6.00
13.01
0.96
34.39
1.00
1.22
0.69
0.30
19.54
6.27
5.25
oz ................................................................................
qt .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
oz ................................................................................
voucher ($) ..................................................................
128
16
..........................
36
1
2
..........................
1
..........................
..........................
6.00
127.59
13.01
0.96
34.39
1.00
1.22
0.69
0.30
19.54
6.27
5.25
144
22
..........................
..........................
..........................
36
1
1
..........................
1
..........................
18
8.00
143.40
16.90
1.66
0.05
0.97
35.09
1.00
0.63
0.35
0.60
38.63
13.41
7.00
96
16
..........................
..........................
..........................
36
1
1
..........................
..........................
8.00
95.54
11.68
1.29
0.02
0.95
34.70
0.95
0.23
14.69
9.06
7.00
144
24
..........................
..........................
..........................
1
36
2
1
..........................
30
..........................
143.64
17.51
1.46
0.01
1.60
1.00
35.87
1.98
0.63
0.35
........................
22.44
Women: Food Package V
V:
Juice ......................................................................
Milk, fat-reduced ....................................................
Soy beverage .................................................
Tofu ................................................................
Cheese ...........................................................
Cereal ....................................................................
Eggs ......................................................................
Whole grain bread .................................................
Other grains ...................................................
Beans, dried 44 ......................................................
Beans, canned ...............................................
Peanut butter .................................................
Fruit and vegetable voucher.43 .............................
oz ................................................................................
qt .................................................................................
qt .................................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
oz ................................................................................
voucher ($) ..................................................................
Women: Food Package VI
VI:
Juice ......................................................................
Milk, fat-reduced ....................................................
Soy beverage .................................................
Tofu ................................................................
Cheese ...........................................................
Cereal ....................................................................
Eggs ......................................................................
Beans, dried 44 ......................................................
Beans, canned ...............................................
Peanut butter .................................................
Fruit and vegetable voucher.43 .............................
oz ................................................................................
qt .................................................................................
qt .................................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
oz ................................................................................
oz ................................................................................
voucher ($) ..................................................................
Women: Food Package VII
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VII:
Juice ......................................................................
Milk, fat-reduced ....................................................
Soy beverage .................................................
Tofu ................................................................
Cheese ...........................................................
Cheese ..................................................................
Cereal ....................................................................
Eggs ......................................................................
Whole grain bread .................................................
Other grains ...................................................
Canned fish ...........................................................
Tuna ...............................................................
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oz ................................................................................
qt .................................................................................
qt .................................................................................
lb .................................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
oz ................................................................................
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69020
Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
TABLE 4.—PRESCRIPTION ESTIMATES UNDER INTERIM RULE 38—Continued
Units 39
Maximum
amount per
food category 40
oz ................................................................................
lb .................................................................................
oz ................................................................................
oz ................................................................................
voucher ($) ..................................................................
..........................
1
..........................
18
10.00
Food package
Salmon, sardines, mackerel ..........................
Beans, dried 44 ......................................................
Beans, canned ...............................................
Peanut butter .........................................................
Fruit and vegetable voucher.43 .............................
Estimated
average
prescribed
amount
6.11
0.60
38.63
13.41
8.75
TABLE 5.—PRESCRIPTION ESTIMATES FOR CURRENT FOOD PACKAGES
Maximum
amount per
food category
Units 45
Food package
Estimated
average
prescribed
amount
Infants: Food Package I
I—Fully breast-fed:
Formula .................................................................
I—Partially breast-fed:
Formula .................................................................
I—Fully formula-fed:
Formula .................................................................
reconstituted fluid oz ...................................................
806
79.58
reconstituted fluid oz ...................................................
806
546.55
reconstituted fluid oz ...................................................
806
906.33
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
806
96
24
77.38
34.09
20.63
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
806
96
24
613.76
53.80
16.60
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
806
96
24
906.33
41.93
16.99
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
806
96
24
77.12
81.15
22.28
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
806
96
24
637.89
69.30
21.08
reconstituted fluid oz ...................................................
oz ................................................................................
oz ................................................................................
806
96
24
906.33
76.42
20.27
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II—Fully breast-fed 4–6.9 mo:
Formula .................................................................
Juice ......................................................................
Cereal ....................................................................
II—Partially breast-fed 4–6.9 mo:
Formula .................................................................
Juice ......................................................................
Cereal ....................................................................
II—Fully formula-fed 4–6.9 mo:
Formula .................................................................
Juice ......................................................................
Cereal ....................................................................
II—Fully breast-fed 7–11.9 mo:
Formula .................................................................
Juice ......................................................................
Cereal ....................................................................
II—Partially breast-fed 7–11.9 mo:
Formula .................................................................
Juice ......................................................................
Cereal ....................................................................
II—Fully formula-fed 7–11.9 mo:
Formula .................................................................
Juice ......................................................................
Cereal ....................................................................
38 The only significant change to Food Package III
in the interim rule is the proposed addition of foods
to these recipients’ packages when their medical
circumstances allow it. The PC2002 data set
indicates that about 1 percent of WIC participants
receive Food Package III. FNS assumes that half of
them will be able to and will choose to receive all
of the other foods available to them under the
proposed rule. Therefore, we do not calculate
prescription rates for Food Package III.
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39 Units are expressed in: fluid ounces (fluid oz);
ounces (oz); pounds (lb); quarts (qt); and, dozens
(doz).
40 Infant formula amounts are expressed in the
full nutritional benefit amount of reconstituted
liquid concentrate required for that age group. The
interim rule details the maximum formula amounts
allowed for each form of infant formula.
41 Although partially breastfed infants will be
allowed up to 104 reconstituted fluid ounces in the
first month following birth in the interim rule, this
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analysis does not estimate a prescribed amount. For
more discussion, see Section E, Item 3.
42 Total ounces for dried beans, canned beans and
peanut butter exceed 1lb because participants can
substitute 64 ounces of canned beans or 18 ounces
of peanut butter for 1lb of dried beans.
43 Prescribed amount for fruit and vegetable
vouchers is the redemption rate as discussed in 3a
(iii) within this section.
44 Total ounces for dried and canned beans
exceed 1lb because participants can substitute 64
ounces of canned beans for 1lb of dried beans.
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TABLE 5.—PRESCRIPTION ESTIMATES FOR CURRENT FOOD PACKAGES—Continued
Maximum
amount per
food category
Units 45
Food package
Estimated
average
prescribed
amount
Children: Food Package IV
IV:
Juice ......................................................................
Milk ........................................................................
Cheese ..................................................................
Cereal ....................................................................
Eggs ......................................................................
Beans, dried ..........................................................
Peanut butter .........................................................
oz ................................................................................
qt .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
oz ................................................................................
288
24
..........................
36
2.5
1
..........................
232.77
16.58
1.57
34.39
1.83
0.61
6.27
288
28
..........................
36
2.5
1
..........................
267.83
20.94
1.84
35.09
1.99
0.55
7.29
192
24
..........................
36
2.5
185.54
17.15
1.65
34.70
1.78
336
28
..........................
1
36
2.5
1
18
26
2
319.32
22.28
1.65
1.00
35.87
2.00
1.20
13.41
24.75
1.99
Women: Package V
V:
Juice ......................................................................
Milk ........................................................................
Cheese ..................................................................
Cereal ....................................................................
Eggs ......................................................................
Beans, dried ..........................................................
Peanut butter .........................................................
oz ................................................................................
qt .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
oz ................................................................................
Women: Package VI
VI:
Juice ......................................................................
Milk ........................................................................
Cheese ..................................................................
Cereal ....................................................................
Eggs ......................................................................
oz ................................................................................
qt .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
Women: Package VII
VII:
Juice ......................................................................
Milk ........................................................................
Cheese as milk substitute .....................................
Cheese ..................................................................
Cereal ....................................................................
Eggs ......................................................................
Beans, dried ..........................................................
Peanut butter .........................................................
Tuna ......................................................................
Carrots ...................................................................
iv. Food Prices
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The price data used in this analysis is
based primarily on tabulations from the
calendar year 2005 AC Nielsen Homescan
dataset.46 Homescan data is captured by AC
Nielsen panel members who record their
purchases at home with handheld scanners.
This type of panel data is well-suited to the
WIC food package analysis. Unlike data
gathered from point of sale scanners, panel
data is potentially more comprehensive; it is
able to capture purchases from retailers of
every size and type, including supermarkets,
convenience stores, drug stores, and vendors
45 Units are expressed in fluid ounces (fluid oz),
ounces (oz), pounds (lb), quarts (qt), and dozens
(doz).
46 Prices displayed in Table 6 are inflated to FY
2006 levels using Bureau of Labor Statistics CPI
estimates.
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oz ................................................................................
qt .................................................................................
lb .................................................................................
lb .................................................................................
oz ................................................................................
doz ..............................................................................
lb .................................................................................
oz ................................................................................
oz ................................................................................
lb .................................................................................
who lack checkout scanning equipment.47 In
addition, demographic information collected
from Homescan panelists allows FNS to
distinguish shoppers with WIC-eligible
incomes from the rest of the population.
Homescan panels are geographically and
demographically stratified random samples
of individuals weighted to represent all U.S.
households. A few of the demographic strata
used by Nielsen are household size,
household income, household race, and
several characteristics of the head of
household. Nielsen monitors and evaluates
the performance of panelists, and data
collected by panelists undergo various
internal consistency checks. (No commenters
on the proposed rule raised questions or
identified potential limitations with regard to
AC Nielsen Homescan data.)
47 Homescan data also captures purchases of nonUPC coded (non-scannable) random weight items
such as fresh produce.
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FNS had access to two Homescan panel
samples. The 39,000 panelists in the first
sample record calendar year 2005 purchases
of all scannable products. A smaller
subsample of 8,200 panelists record
purchases of all items, including random
weight, non-UPC-coded items. Most of the
foods in the current and interim rule food
packages are UPC-coded, standard-weight,
pre-packaged (i.e., scannable) items. For that
reason, most of the prices computed by FNS
are taken from purchases recorded by the
larger Homescan panel.
FNS focused its analysis on purchases by
individuals with WIC-level incomes. FNS
generated its own subsamples of panelists
whose reported household size and annual
income indicate that they are WIC incomeeligible. The income-eligible working dataset
drawn from the larger of the two Homescan
panels (used for most of FNS’s price
computations) contains 8,400 panelists. The
working dataset drawn from the smaller
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panel (used in few of FNS’s price
computations) contains 1,600 panelists.
a. Computation of Average Prices
For each of the food items in the current
or interim packages, FNS computed the
average price paid by households with WICeligible incomes. All prices are weighted by
the aggregate volumes purchased by WICeligible product variety, container size,
flavor, brand, etc.
Product descriptions captured by Nielsen
sometimes lack the detail necessary to
separate WIC-eligible items from non-eligible
items. For this reason, the selection of
products from the Nielsen datasets
necessitates some compromise. The average
prices computed by FNS and a brief
description of FNS’s product selection
criteria are shown in Table 6.
Food prices obtained from AC Nielsen
Homescan data are inflated to FY 2006 levels
with CPI estimates published by Bureau of
Labor Statistics. Food items or categoryspecific inflation estimates were used, when
available. For years after FY 2006, food costs
are inflated by the Office of Management and
Budget’s November, 2006 Thrifty Food Plan
(TFP) index except for the fruit and vegetable
vouchers which are inflated by the USDA’s
agricultural baseline projections for retail
fruit and vegetable prices. (See Tables B and
C in Appendix A for more detail.)
In each case, prices are computed only for
products in container sizes consistent with
current WIC regulations, typical state agency
requirements, or the interim rule. Products
identified as organic were excluded; states
typically disallow organic varieties for cost
reasons. FNS also adjusted infant formula
prices to account for State agencies
prescribing infant formulas enhanced with
DHA/ARA, which tend to cost WIC more
than non-enhanced infant formulas. This
analysis provides a conservative estimate that
assumes all states will issue enhanced infant
formulas exclusively during the five-year
period.48
TABLE 6.—WIC FOODS: FOOD ITEM, SELECTION CRITERIA, UNITS, AND PRICES PER UNIT
Food item
Infant formula (post rebate):49
Powdered ..............................................................
Weighted average of all forms.51 .........................
Infant cereal (post rebate) ...........................................
Infant food:
Infant fruit and vegetables ....................................
Infant food meat ....................................................
Bananas ................................................................
Milk:
Whole ....................................................................
Reduced fat ..........................................................
Cheese .........................................................................
Yogurt ...........................................................................
Tofu ..............................................................................
Soy beverage ...............................................................
Juice .............................................................................
Adult cereal ..................................................................
Eggs .............................................................................
Beans:
Dry ........................................................................
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Canned .................................................................
Peanut butter ...............................................................
Whole-grain bread .......................................................
Brown rice ....................................................................
Tuna .............................................................................
Other canned fish ........................................................
Carrots .........................................................................
48 This assumption is based on the percentage of
States exclusively issuing enhanced formula as of
the February 2007 rebate contract summary of 94%.
Based on current trends, FNS believes the
percentage of States exclusively issuing enhanced
formula will be 100% at the time of
implementation.
49 The average prices computed for infant formula
are based on a range of container sizes commonly
prescribed by WIC clinics. Formula prices, unlike
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Price per unit
(inflated to
FY06)
Retail sales database selection criteria
Jkt 214001
Units
Enhanced formulas 50 in powdered, liquid concentrate, and ready-to-feed forms.
....................................................................................
Dry grains without added fruit or other flavors ..........
oz ....................
$0.0312
oz ....................
oz ....................
0.0331
0.125
Any texture; plain fruits or vegetables .......................
All plain meat varieties ..............................................
Fresh. .........................................................................
oz ....................
oz ....................
lb .....................
0.122
0.346
0.456
Fresh dairy milk only, 1⁄2 gallon or gallon containers.
Reduced fat includes skim milk and milk identified
as 2% or lower milk fat.
....................................................................................
Processed American and domestic natural cheddar,
Colby, mozzarella, brick, Monterey jack. Sliced or
un-sliced varieties.
Quart sized containers and larger. Plain, vanilla, and
fruit flavors.
Plain varieties ............................................................
Half gallon or larger sizes. Plain varieties.52 .............
Apple, grape, orange, grapefruit, tomato. Unsweetened 100% juice.
Weighted average of cereals commonly prescribed
by state WIC agencies and whole-grain varieties.
Hot or ready-to-eat.
Large or medium, white. One-dozen containers only
qt .....................
0.767
qt .....................
lb .....................
0.708
3.292
qt .....................
2.068
lb .....................
qt .....................
oz ....................
1.467
1.370
0.032
oz ....................
0.159
doz ..................
0.931
lb .....................
0.805
oz ....................
oz ....................
lb .....................
lb .....................
oz ....................
oz ....................
lb .....................
0.037
0.094
1.422
1.178
0.101
0.114
0.953
Most varieties, excluding string beans and immature
peas. Not mixed with other foods.
....................................................................................
All forms and varieties. Not mixed with jelly .............
Wheat or grain bread .................................................
Instant or regular .......................................................
Chunk light, canned ...................................................
Salmon, sardines and mackerel, canned ..................
Fresh, frozen, canned ................................................
the prices computed for other products in this
analysis, are based on purchases by all individuals,
not just those with WIC-eligible incomes. This has
little consequence on the average price since more
than half of the infant formula purchased in the
U.S. is purchased by WIC participants.
50 The term ‘‘enhanced formulas’’ means formulas
that have been enhanced with two fatty acids, DHA
and ARA.
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51 The weighted average price is used throughout
this analysis except when pricing the value of
formula prescriptions, under the interim rule, for
partially breastfeeding infants age 0–3 months. For
that one group, the interim rule recommends the
prescription of powder alone.
52 The price reflects purchases by individuals at
all income levels. The dataset contained too few
sample records when limited to purchases by
individuals with WIC-eligible incomes.
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v. Participant Projections
For this analysis, FNS makes the
straightforward assumption that overall WIC
participation will grow at a fixed 2.08%
annual rate from February 2007 through the
end of fiscal year 2012. 2.08% is a simple
average of the annual observed rates of
growth for each of the seven years that ended
in January 2007. The participant data used to
generate this growth rate is remitted by the
States to FNS on a monthly basis. Participant
data are reviewed for possible collection,
transmission, or keying errors, but are
otherwise unadjusted by FNS. The
participant growth assumption used in this
analysis is intended to illustrate the potential
cost impacts of the revised food package over
time and should not be construed as
reflecting any policy or projection of future
WIC participation.
Consistent with the IOM assumptions, we
do not assume any changes in participation
under the interim rule due to potential
participants finding the revised package more
or less attractive. (For more detail on
participation levels by food package see
Tables D and E in Appendix A.)
Many of the package changes were
intended to encourage breastfeeding.
However, it is important to note that this
analysis does not provide an estimate of the
increase in the number of breastfed infants or
the additional length of time that infants will
be breastfed. Due to the complex set of
factors (demographic, social, environment,
clinical, etc.) that influence breastfeeding
duration, we are unable to estimate the
number of infant/mother pairs that will
switch food packages as their feeding
practices change. This is consistent with the
analysis provided by IOM.
The assumption of no change in
breastfeeding patterns yields the most
conservative cost estimate, as the net impact
of increases in breastfed infants and
breastfeeding women participants reduces
the costs of this proposal. IOM conducted a
sensitivity analysis by simulating possible
shifts in participation rates. Shifting infant/
mother pairs from the fully formula-fed
package to the breastfeeding packages has the
effect of moving infant/mother pairs from the
most expensive set of packages to less
49 The average prices computed for infant formula
are based on a range of container sizes commonly
prescribed by WIC clinics. Formula prices, unlike
the prices computed for other products in this
analysis, are based on purchases by all individuals,
not just those with WIC-eligible incomes. This has
little consequence on the average price since more
than half of the infant formula purchased in the
U.S. is purchased by WIC participants.
50 The term ‘‘enhanced formulas’’ means formulas
that have been enhanced with two fatty acids, DHA
and ARA.
51 The weighted average price is used throughout
this analysis except when pricing the value of
formula prescriptions, under the interim rule, for
partially breastfeeding infants age 0–3 months. For
that one group, the interim rule recommends the
prescription of powder alone.
52 The price reflects purchases by individuals at
all income levels. The dataset contained too few
sample records when limited to purchases by
individuals with WIC-eligible incomes.
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expensive ones. A constant shift of 30
percent for one to 11 months of age from
partial to full breastfeeding and a smaller
range of shifts from full formula feeding to
full breastfeeding (with an appropriate shift
in the mother’s classification) decreased the
average package cost by nearly two percent.53
vi. Phased Implementation
The analysis assumes the rule takes effect
in December 2007 (FY08). During the phasein period, State agencies will be required to
issue food benefits based on either the new
food packages or current food packages but
cannot combine the two. State agencies may
also phase-in new food packages on a
participant category basis.
Based on comments from State and local
agencies, the interim rule’s phased-in period
has been revised to reflect an 18-month
period, six months longer than the
implementation period in the proposed rule.
In the interim rule, the elimination of juice
from the infant food packages is phased-in
over 18 months, rather than six months as
stated in the proposed rule, from publication
of the rule.
All phase-in effects are reflected in the cost
estimates contained in Table 2. This analysis
assumes that the remaining provisions of the
rule will be phased-in over the course of 18
months beginning December 2007. It is
assumed, as above, that States will
implement the provisions of the rule
throughout the phase-in period; the effective
rate of implementation is averaged over the
course of 18 months.54 The rule’s phase-in
schedule reduces total costs in FY 2008 by
$11.1 million. FY 2009 costs are reduced by
an estimated $1.1 million.
vii. State Cost Variation
This analysis is based on national average
prescription and price data, which indicates
that program-wide, the changes are cost
neutral. States may vary somewhat in their
implementation experiences, depending on
how closely their prescription practices and
prices correspond to the national averages.
WIC funding rules help address these
implementation issues. The food funding
formula provides mechanisms for
transferring funds from States which are not
fully utilizing their grants to those with need
for additional funding, and these
mechanisms have been successfully used in
the past to address variations in States’
funding needs.
b. Administrative Costs
State agencies and local WIC providers will
incur some new costs to implement the rule.
A total of six State agencies provided
comments on the proposed rule that
specifically addressed costs associated with
implementation. In general, these States
believed that additional nutrition services
and administration (NSA) funds would be
needed to update and enhance MIS systems,
53 See
IOM, p. 140.
the phase-in rate increases linearly, the rule
would not be fully effective until July 2009. As a
rough approximation, it is assumed that the
effective rate of implementation of all provisions
throughout FY 2008 averages 31 percent, with the
remainder realized in the first eight months of FY
2009.
54 If
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69023
train staff, participants and vendors, and
update food lists. However, none of these
commenters attempted to quantify their
expected costs.
Many of the costs of implementation are
similar in type to the routine recurring costs
of operating a WIC program. These include
training WIC clinic and administrative staff,
and the periodic review and updating of
WIC-approved food lists to assist vendors
with their own staff training. Much of the
training-related cost that State and local
agencies will incur as a result of the rule will
therefore displace similar recurring expenses
during the phase-in period.
Other costs, such as modifying MIS
systems, are non-routine expenses tied
exclusively to the transition to a new set of
food packages. However, MIS systems vary
greatly across the States, and the effort
needed to modify these systems will vary as
well. FNS is not in a position to assess the
level of work faced by State and local
agencies. As a result, the cost of modifying
State MIS systems cannot be estimated.
Despite their concerns, States were
overwhelmingly supportive of the proposed
changes; one State comment stated directly
the judgment that the benefits from
implementing the new packages will
outweigh the effort needed to implement the
changes.
FNS believes that State agencies and local
WIC providers will be able to absorb the
burden associated with implementing this
rule within current NSA funds. State and
local agencies have substantial flexibility in
how they spend their NSA funds and may
need to reprioritize or postpone some
initiatives to undertake the implementation
activities associated with this rule. Given the
extremely positive response that this rule has
received within the WIC community at both
the State and local levels, we fully expect
that implementation will be a priority.
E. Uncertainties
The estimate developed above is sensitive
to changes in several key assumptions. A few
of the most significant are discussed here.
1. Price Volatility in the Dairy Market
Instability in dairy prices over the last
several years presents a major element of
uncertainty in the cost estimate. However,
the maximum amount of milk available in
each of the food packages is reduced. The
total amount of milk that can be replaced
with more expensive substitutes has been
reduced as well. These factors make the
revised food packages less sensitive to dairy
price fluctuations than the current WIC
packages. FNS examined the impact of a 10%
increase and a 10% decrease in the price of
milk and cheese. Since the amount of milk
and cheese is being reduced in the interim
packages, higher dairy prices would produce
a net savings. That is, while higher dairy
prices would increase the absolute cost of the
interim rule’s food packages, an equivalent
dairy price increase would increase the
absolute cost of the current rule’s packages
by an even greater amount. Because the
increased cost is relatively smaller under the
interim rule, a dairy price increase will
reduce the cost of adopting the rule; the
$29.7 million savings under our baseline
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assumptions would become a $222.5 million
savings. Similarly, lower dairy prices would
increase the cost of adopting the interim rule.
The impact of these price changes is
summarized in the following table:
TABLE 7.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS, ASSUMING A 10% INCREASE OR A 10% DECREASE IN
DAIRY PRICES
[In $ millions]
FY 2008
Cost/Savings of Rule with 10% Increase in Dairy Prices .......................
Cost/Savings of Interim Rule ...................................................................
Difference Between Base Assumption and 10% Price Increase ............
Cost/Savings of Rule with 10% Decrease in Dairy Prices ......................
Cost/Savings of Interim Rule ...................................................................
Difference Between Base Assumption and 10% Price Decrease ...........
FY 2009
FY 2010
FY 2011
FY 2012
–$5.8
5.0
10.8
15.8
5.0
–10.8
–$30.8
7.3
38.2
45.5
7.3
–38.2
–$48.4
–2.5
45.9
43.3
–2.5
–45.9
–$61.8
–13.9
47.9
34.0
–13.9
–47.9
–$75.7
–25.6
50.0
24.4
–25.6
–50.0
Total
–$222.5
–29.7
192.8
163.1
–29.7
–192.8
Negative values are cost reductions. Differences may not be exact due to rounding.
2. Assumed Preference for Soy Beverage
FNS estimates that as many as 10% of
women will request soy beverage in place of
liquid milk, if provided the choice.55 The
IOM cites high rates of lactose maldigestion
and low rates of cultural acceptability of milk
among African American and Asian women
as important factors in its decision to
introduce substitutes for milk.56 African
American women are represented in the WIC
population at a level disproportionate to their
share of the general population. In part for
that reason, it is appropriate to assume a WIC
participant preference for soy beverage at or
near the upper range of estimates of soy
beverage consumption in the U.S. as a whole.
And because WIC participants may choose
freely between milk and the more expensive
soy substitute, without regard to cost, a
natural response is consumption at a rate
above the rate of those whose choice between
the two products has personal cost impact.
FNS determined which women in the 2002
WIC prescription dataset were provided
neither milk nor cheese. Those individuals,
as a group, are assumed to be the WIC
participants most inclined to request a
prescription of soy beverage in place of milk.
FNS’ simulation model prescribes an amount
of soy beverage to those individuals equal to
the maximum allowed under their respective
food packages. The program then substitutes
soy beverage for the existing milk
prescriptions of other WIC participants to the
extent necessary to reach the 10% participant
target. The program prescribes cheese and
tofu before soy beverage; it does not replace
the prescription of those milk substitutes
with soy beverage. IOM took a similar
approach in developing its cost estimate; it
assumed that soy beverage would replace
10% of liquid milk prescriptions. In IOM’s
analysis, 8.7% of all milk and milk
substitutes prescribed to women is in the
form of soy beverage. FNS’ methodology,
which incorporates the more detailed data
available from PC2002, results in a somewhat
lower 7.6% substitution rate for soy beverage.
Precise data on which to base a soy
beverage consumption rate for adult women
is not available; it is not known whether
consumption is appreciably higher or lower
among women than among the population
generally. For these reasons, the cost of the
interim rule has been re-estimated using two
alternate assumptions. If soy beverage is
prescribed to only 5% of women, the average
Package V, VI, and VII soy beverage
substitution rate is 3.8%. Conversely if soy
beverage is prescribed to approximately 15%
of women, the average Package V, VI, and VII
soy beverage substitution rate is 11.4%.
Given the high cost of soy beverage relative
to milk, this uncertainty would have cost
implications.
TABLE 8.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS, ASSUMING 5% OR 15% OF WOMEN ARE PRESCRIBED
SOY BEVERAGE
[in $ millions]
FY 2008
Cost/Savings of Rule with alternate 5% prescription rate .......................
Cost/Savings of Interim Rule ...................................................................
Difference Between Base Assumption and 5% Prescription Rate ..
Cost/Savings of Rule with alternate 15% prescription rate .....................
Cost/Savings of Interim Rule ...................................................................
Difference Between Base Assumption and 15% Prescription Rate
FY 2009
FY 2010
FY 2011
FY 2012
$1.5
5.0
3.5
8.4
5.0
–3.5
–$4.9
7.3
12.2
19.5
7.3
–12.2
–$17.2
–2.5
14.7
12.1
–2.5
–14.7
–$29.2
–13.9
15.3
1.4
–13.9
–15.3
–$41.6
–25.6
16.0
–9.6
–25.6
–16.0
Total
–$91.4
–29.7
61.6
31.9
–29.7
–61.6
Negative values are cost reductions. Differences may not be exact due to rounding.
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3. State option to provide formula for infants
0–0.9 months of age
The proposed rule put forth three options
for infant feeding within the first month of
birth: (1) Fully formula feeding; (2) fully
breastfeeding; or (3) partially breastfeeding.
The Proposed Rule did not allow formula to
be provided for partially breasted infants
under one month of age. This interim rule
will allow partially breastfed infants in the
first month of life to receive no more than
104 reconstituted fluid ounces of infant
formula. Food Package V will be provided to
mothers of these partially breastfeeding
infants.
As shown in Table 9, the low amount of
formula provided to partially breastfeeding
infants under one month of age and the
difference in the women’s packages provides
a cost savings when infant/mother pairs
move to the partially breastfeeding packages
during the first month after birth. FNS does
not know how many fully formula feeding
and fully breastfeeding mothers would opt to
partially breastfeed during the infant’s first
month. However, given that the monthly cost
of the food packages for a partially
breastfeeding pair is less than the cost of the
packages for either a fully breastfeeding or
fully formula feeding pair, even a relatively
55 AC Nielsen Homescan data indicate that
approximately 10% of households with WICeligible incomes purchased some type of soy
beverage during FY 2003. Soy beverage cannot be
identified precisely in the AC Nielsen dataset. The
10% consumption figure is based on a broad
product definition that includes soy beverage
varieties that are not WIC-eligible under the interim
rule. FNS sought to identify women who might
request plain soy beverage if it is offered, cost-free,
as a milk substitute. The estimate developed here
assumes that this group will include some women
who are current consumers of more popular soy
beverage varieties.
56 IOM, p. 119.
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large shift to the partially breastfeeding
69025
packages does not threaten the overall cost
neutrality of the interim rule.
TABLE 9.—COMBINED MONTHLY FOOD PACKAGE COSTS FOR INFANT/MOTHER PAIRS OF INFANTS 0–0.9 MONTHS,
ASSUMING ONE CAN OF FORMULA FOR PARTIALLY BREASTFEEDING INFANTS IN FIRST MONTH
Monthly food package costs (FY 2006)
Mother
Fully Formula Fed Feeding Pair ..................................................................................................
Partially Breast Fed Feeding Pair ...............................................................................................
Cost/Savings of Moving to Partially Breast Fed Packages .................................................
Fully Breast Fed Feeding Pair .....................................................................................................
Partially Breast Fed Feeding Pair ...............................................................................................
Cost/Savings of Moving to Partially Breast Fed Packages .................................................
4. Prescription Assumptions for Whole Grain
Bread and Bread Substitutes
Because whole grain bread and bread
substitutes are new additions to the WIC food
packages, FNS had to develop prescription
assumptions for these foods without the
benefit of historic prescription data. For
Infant
$31.23
40.09
$8.86
51.30
40.09
–$11.21
purposes of this cost estimate FNS assumed
that whole grain bread and bread substitutes
would be prescribed to WIC participants at
rates comparable to the observed prescription
rates for breakfast cereal, the most closely
related food in the current WIC packages.57
For children’s Package IV, FNS applied an
observed cereal prescription rate of 95.4%.
Pair
$27.90
3.25
–$24.66
0.00
3.25
$3.25
$59.14
43.34
–$15.80
51.30
43.34
–$7.96
For packages V and VII, FNS applied an
observed average rate of 97.7%.
Table 10 recomputes the cost effect of the
interim rule under the alternate assumptions
that the actual whole grain bread prescription
rates for food packages IV, V, and VII will be
as low as 90%, or as high as 100%.
TABLE 10.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS ASSUMING 90% AND 100% WHOLE GRAIN
PRESCRIPTION RATES
FY 2008
Cost/Savings of Rule with 90% Whole Grain Prescription Rate .............
Cost/Savings of Interim Rule ...................................................................
Difference Between Base Assumption and 90% Prescription Rate
Cost/Savings of Rule with 100% Whole Grain Prescription Rate ...........
Cost/Savings of Interim Rule ...................................................................
Difference Between Base Assumption and 100% Prescription Rate
5. Prescription Assumptions for Infant Food
Fruits and Vegetables, and Infant Food Meat
Jarred infant foods, like whole grain
breads, are new additions to the WIC food
packages. Without the benefit of historic
prescription rates for these foods, FNS had to
look elsewhere for a prescription assumption
to use in its cost estimate. FNS considered
FY 2009
FY 2010
FY 2011
FY 2012
$2.6
5.0
$2.4
6.8
5.0
–$1.8
$1.2
7.3
$8.5
13.7
7.3
–$6.4
–$12.8
–2.5
$10.3
5.1
–2.5
–$7.7
–$24.6
–13.9
$10.7
–5.9
–13.9
–$8.0
–$36.8
–25.6
$11.2
–17.3
–25.6
–$8.4
and rejected infant fruit juice prescriptions as
a proxy, despite the fact that the jarred food
benefit is comprised primarily of fruits and
vegetables. Infant juice prescriptions fall well
below 100%, largely because states recognize
that the current package maximums exceed
amounts recommended by current nutrition
science. FNS believes that the interim rule’s
infant foods will be prescribed at a much
Total
–$72.9
–29.7
$43.1
2.5
–29.7
–$32.3
higher rate. For this reason, FNS assumes
that the jarred infant food prescription rate
will match the observed 94.3% prescription
rate for fruit juice across WIC’s women’s food
packages.58
Table 11 recomputes the cost effect of the
interim rule under the alternate assumptions
that jarred infant food prescriptions will be
as low as 90%, or as high as 100%.
TABLE 11.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS ASSUMING 90% AND 100% JARRED INFANT FOOD
PRESCRIPTIONS
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
Total
$2.1
5.0
¥$2.7
7.3
¥$14.6
¥2.5
¥$26.5
¥13.9
¥$38.8
¥25.6
¥$80.4
¥29.7
Difference Between Base Assumption and 90%
Prescription Rate ...................................................
2.8
10.0
12.0
12.6
13.1
50.6
Cost/Savings of Rule with 100% Infant Food Prescription Rate .......................................................................
Cost/Savings of Interim Rule ...........................................
8.7
5.0
20.4
7.3
13.1
¥2.5
2.5
¥13.9
¥8.6
¥25.6
36.0
¥29.7
Difference Between Base Assumption and 100%
Prescription Rate ...................................................
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Cost/Savings of Rule with 90% Infant Food Prescription
Rate ..............................................................................
Cost/Savings of Interim Rule ...........................................
¥3.7
¥13.0
¥15.6
¥16.3
¥17.1
¥65.8
57 Observed
rates were taken from PC2002.
the estimate assumes no rounding up
of jarred infant foods, the net average prescription
58 Because
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rate is slightly less than 94.3% for baby food fruits
and vegetables. The average prescription for baby
food meat is a full 94.3%, however, because the
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6. Changes in Current Food Package Sizes
The current and interim rules specify
maximum food allowances in units of weight
or volume. Several comments on the
Proposed Rule asked that food allowances be
expressed in package units, such as number
of jars or containers, or that maximum
weights and volumes match package sizes
currently available. Specifically, issues were
raised regarding current package sizes of
juice, jarred infant foods and whole grain
bread (further discussed in Section F, Item 2).
FNS recognizes that package sizes of WICeligible foods vary among manufacturers as
well as regions. FNS also recognizes that
manufacturers may change package sizes at
any time. However, basing the maximum
allowances in the interim rule on package
sizes does not reduce the possibility of future
changes in package sizes. This cost estimate
does not incorporate any potential changes in
package sizes but assumes that the maximum
monthly allowance will be able to
accommodate future changes to food
packages sizes.
7. Uncertainties Summary
Table 12 presents two additional cost
estimates that reflect the potential aggregated
effect of these alternative assumptions. The
first assumes that all of the cost increasing
alternate assumptions discussed above are
realized. The second assumes that all of the
cost decreasing alternate assumptions are
realized.
Scenario 1:
a. Jarred infant foods will be prescribed at
a 100% rate to eligible infants
b. Whole grain bread and bread substitutes
will be prescribed at a 100% rate
c. 15% of women will be prescribed some
soy beverage as a milk substitute
d. Dairy prices will decrease by 10%
Scenario 2:
a. Jarred infant foods will be prescribed at
a 90% rate to eligible infants
b. Whole grain bread and bread substitutes
will be prescribed at a 90% rate
c. 5% of women will be prescribed some
soy beverage as a milk substitute
d. Dairy prices will increase by 10%
The resulting combined range of
uncertainty based on these assumptions is
from a savings of $342 million to a cost of
$359 million over five years, or ¥1.1% to
+1.2% of total projected WIC program costs
during that period, relative to the base
assumptions.
TABLE 12.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS UNDER ALTERNATE EXTREME ASSUMPTIONS
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
Total
Cost of Rule Under Scenario 1 .......................................
Cost/Savings of Interim Rule ...........................................
$25.1
5.0
$78.4
7.3
$82.9
¥2.5
$75.4
¥13.9
$67.6
¥25.6
$329.3
¥29.7
Difference Between Base Assumption and Scenario
1 ............................................................................
¥20.1
¥71.0
¥85.4
¥89.3
¥93.2
¥359.1
Savings of Rule Under Scenario 2 ..................................
Cost/Savings of Interim Rule ...........................................
¥14.2
5.0
¥60.3
7.3
¥83.8
¥2.5
¥98.8
¥13.9
¥114.3
¥25.6
¥371.4
¥29.7
Difference Between Base Assumption and Scenario
2 ............................................................................
19.2
67.6
81.3
84.9
88.7
341.6
F. Alternatives
Based on comments received, FNS
considered several alternatives to the
Proposed Rule. Some of these alternatives are
discussed below. Each of these alternatives
was ultimately rejected because FNS believes
that a food package which reflects the IOM
recommendations as closely as possible
within the constraint of cost neutrality best
reflects current scientific consensus on how
to meet the dietary needs of WIC
participants.
1. Include Yogurt as a Milk Substitute for
Food Packages IV–VII
For Food Packages IV–VII, the IOM
identified yogurt, tofu, and soy beverage as
new milk substitutes to help ensure adequate
calcium intake by those who cannot consume
milk and to accommodate cultural
preferences. Under the current rule cheese is
also available as a milk substitute for up to
three quarts of milk. IOM’s recommendation
specifically called for substituting one quart
of yogurt or tofu for one quart of milk, and
for limiting substitutions of cheese, yogurt,
and tofu to four quarts of milk for Food
Packages IV, V and VI, and six quarts of milk
for Food Package VII. Soy beverage would be
allowed for the entire milk allowance for
Food Packages V, VI, and VII.
In order to maintain cost-neutrality, the
Proposed Rule eliminated yogurt as a milk
substitute, but allows the substitution of tofu,
cheese and soy beverages up to the IOM
maximum substitution level. As shown in
Table 13, the price of yogurt, $2.07 per quart,
as compared to $.71 per quart for reducedfat milk, considerably increases the monthly
cost of Food Packages IV–VII. Soy beverage
and tofu also have higher per unit costs than
milk; however, the estimated amount of tofu
purchased by WIC participants is
substantially lower than that of yogurt, and
soy beverage is priced lower than yogurt
($.70 less per quart) making it a more costefficient substitute.
TABLE 13.—PROJECTED COST OF YOGURT AS A MILK SUBSTITUTE
Estimated
average
prescribed
amount (qt.)
Food package
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IV ..............................................................................................................................................................
V ...............................................................................................................................................................
VI ..............................................................................................................................................................
VII .............................................................................................................................................................
The economic impact of including yogurt
as a milk substitute is shown in Table 14.
The five year cost of the rule, as modified by
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this alternative, is $384.0 million. The cost of
the interim rule without yogurt is ¥$29.7
million (see Table 2). Therefore, the
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0.86
0.84
0.66
0.83
Price per
unit
(inflated to
FY06)
Cost per
food
package
$2.07
2.07
2.07
2.07
elimination of yogurt is retained in this
interim rule.
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1.37
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69027
TABLE 14.—PROJECTED COST OF WIC FOOD PACKAGE REVISIONS, INCLUDING YOGURT AS A MILK SUBSTITUTE
[In $ millions]
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
Total
Total Cost of Rule with Alternate Assumption .................
Total Cost of Interim Rule ................................................
$28.2
5.0
$89.2
7.3
$95.9
¥2.5
$88.9
¥13.9
$81.8
¥25.6
$384.0
¥29.7
Difference ..................................................................
¥23.2
¥81.9
¥98.4
¥102.8
¥107.4
¥413.7
Negative values are cost reductions. Differences may not be exact due to rounding.
2. Increase the Whole Grain Maximum
Allowance for Women to 24 Ounce
Increments
The Proposed Rule established a maximum
of whole wheat bread or other whole grain—
rice, barley (whole-grain), bulgur (cracked
wheat), oatmeal and soft corn tortillas—
monthly allowance of two pounds for
children in Food Package IV and one pound
for women in Food Packages V and VII. As
recommended by the IOM, this is an
enhancement to the current food packages
which do not provide whole grains (except
in breakfast cereals).
Some comments on the Proposed Rule
stated that most bread loaves are not sold in
one or two pound packages and participants
would have difficulty purchasing the
maximum monthly allowance. In order to
accommodate current bread package sizes the
maximum allowance for whole grains would
need to be increased to 48 ounces for
children and 24 ounces for women. Not only
would changing the whole grain maximum
allowance to accommodate package sizes
currently available in the market significantly
increase the overall cost of the interim rule
(as shown in Table 15), it is not
administratively practical for FNS to change
maximum allowances based on current
manufacturer packaging as they may vary by
region and may change in future years.
Therefore, whole grain maximum allowances
set in the Proposed Rule are retained in this
interim rule.
TABLE 15.—PROJECTED COST (+) / SAVINGS (-) ASSOCIATED WITH INCREASING THE WHOLE GRAIN MAXIMUM
ALLOWANCE FOR WOMEN AND CHILDREN
[In $ millions]
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
Total
Total Cost of Rule with Alternative ........................
Total Cost of Interim Rule ......................................
$25.2
5.0
$78.7
7.3
$83.3
–2.5
$75.8
–13.9
$68.0
–25.6
$331.1
–29.7
Difference ........................................................
–$20.2
–$71.4
–$85.8
–$89.7
–$93.7
–$360.8
Negative values are cost reductions. Differences may not be exact due to rounding.
3. Fresh Fruits and Vegetables for Infants
The Proposed Rule added jarred infant
fruits and vegetables to Food Package II and
jarred infant meats to Food Package II for
fully breast fed infants. Food Package II also
provides a maximum allowance of two
pounds of fresh bananas. Comments on the
Proposed Rule asked that fresh, canned or
frozen fruits and vegetables be allowed in
Food Package II instead of or as an option to
jarred infant fruits and vegetables.
The estimate shown below assumes that
cash value vouchers replace the interim
rule’s current infant fruit and vegetable
provision. The initial value of the vouchers
are set to the nearest whole dollar equivalent
of the interim rule’s recommended quantity
of infant fruits and vegetables. It is assumed
that the vouchers are redeemed and inflated
in the same manner as the fruit and vegetable
vouchers for women and children. In place
of the interim rule’s current provision, a fruit
and vegetable voucher for infants would
reduce the overall cost of the rule by $133.2
million over five years.59
TABLE 16.—PROJECTED COST (+) / SAVINGS (-) ASSOCIATED WITH ISSUING FRESH FRUIT AND VEGETABLE VOUCHERS TO
INFANTS 6–11.9 MONTHS OF AGE
[In $ millions]
FY 2008
FY 2009
FY 2010
FY 2011
FY 2012
Total
Total Cost of Rule with Alternative ..................................
Total Cost of Interim Rule ................................................
$1.0
5.0
–$11.0
7.3
–$27.6
–2.5
–$44.6
–13.9
–$50.9
–25.6
–$133.2
–29.7
Difference ..................................................................
4.0
18.3
25.0
30.8
25.3
103.5
Negative values are cost reductions. Differences may not be exact due to rounding.
pwalker on PROD1PC71 with RULES2
The IOM recommended that commercial
baby food fruits and vegetables and fresh
bananas replace juice in the current package.
The IOM encourages the continuation of full
breastfeeding past 6 months, and
recommended that higher amounts of baby
food fruits and vegetables and baby food
meats be provided to fully breastfeeding
infants. Commercial baby foods were
recommended due to nutrient content,
availability in developmentally appropriate
textures, and food safety.60 In addition, the
59 The savings is a consequence of two factors.
The first is the assumption that fruit and vegetable
vouchers for infants will be issued at their full
values, but redeemed at a rate of just 87.5% (the
same assumption that applies to fruit and vegetable
vouchers for women and children in the baseline
estimate.) The jarred fruit and vegetable benefit, by
contrast, is assumed to be prescribed at an average
rate equal to 94.3% of the package maximum
(95.8% after rounding up to an even number of jars)
and redeemed by beneficiaries at 100%. The second
factor which makes the voucher option relatively
less expensive is the voucher inflation and
rounding rule which limits future increases to
whole dollar increments. The effects of inflation are
accrued annually, but not realized until the
cumulative increase in the CPI is sufficient to raise
the voucher’s value by a dollar. See interim rule
section 246.16(j).
60 IOM, p. 103.
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the price differential between reduced fat
milk ($.71 per quart) and soy beverage ($1.37
per quart), and the number of WIC-eligible
children, substitution of soy beverage for
milk without medical documentation could
result in a significant increase to the overall
cost of the rule.
On both economic grounds and on the
expert recommendation of the IOM, FNS
retains the medical documentation
requirement for soy beverage in the
children’s food package.
provision of commercial baby food fruits and
vegetables helps ensure that these items are
consumed by infants and not other
household members. FNS believes that
nutrition education provided by WIC staff
related to appropriate food choices and home
preparation of foods for infants is compatible
with provision of jarred infant foods.
Therefore, this alternative was rejected.
4. Soy Beverage Substitution for Children
Without Medical Documentation
The Proposed Rule allowed State agencies
to authorize, with medical documentation,
soy-based beverages and tofu substitutions
for milk for children in Food Package IV.
Some comments received on the Proposed
Rule expressed opposition to the medical
documentation requirement citing that it
creates barriers for children to obtain foods
that meet cultural needs.
Requiring medical documentation for dairy
alternatives ensures that a health care
provider is aware that children may be at
nutritional risk when milk is replaced by
other foods. The IOM recommended that soy
beverage not be made available to children to
satisfy participant preference in the absence
of medical need.
Research suggests that up to 4% of
children consume some sort of soy beverage
and that percentage increases as they get
older.61 FNS does not collect data on the
percentage of WIC children who request milk
alternatives, and the percentage of children
that would request soy beverage in place of
milk is difficult to estimate. However, given
G. Market Share Analysis
The changes in the quantities and types of
foods provided by the WIC program should
result in changes in the quantities and types
of foods that WIC participants buy with their
WIC vouchers. The complete market impact
of this rule is difficult to accurately quantify
because we do not know the extent to which
WIC foods substitute for purchases WIC
participants would have otherwise made
with their own funds. Empirical research on
this issue is inconclusive.62 Because of this
uncertainty, we present two scenarios. In the
first (Table 17), we assume full substitution—
that is, all foods purchased with WIC
vouchers under the current packages would
otherwise be purchased with the
participants’ own funds under the interim
rule. In the second (Table 18), we assume the
alternate—that none of the foods purchased
with WIC vouchers would otherwise be
purchased with the participants’ own funds.
In both scenarios, the potential impact of the
interim rule on the total market size for most
foods is relatively modest, as is the impact
on WIC’s share of the total market.
We estimated the total value of WIC sales63
for each food item and the total annual U.S.
retail sales for each WIC food item. To
estimate WIC sales, we multiplied the
average unit price per food item by an
estimate of the quantity of food purchased by
WIC participants (the average estimated
participation multiplied by the amount of
food prescribed to a participant throughout
the course of a year).64 To estimate total
annual sales, 2005 AC Nielsen Productscan
data was used to calculate total volume and
annual grocery store sales of the different
categories of food products.65 We used
calendar year (CY) 2005 participation, cost
and sales estimates for our market share
analysis. Although the rule does not take
effect until FY2008, we cannot reliably make
projections about the overall sales of WIC
food items for the next two years; we believe
the CY2005 data provides a good indication
of the relative impact of the rule’s changes on
each food item.
It is important to note that this approach
understates the size of the total markets for
WIC food items (and thus overstates both
WIC’s market share and the potential impact
of the changes on WIC food markets), because
the data used to estimate total market size is
limited to grocery store sales. Data on sales
through other outlets was not available, but
would likely significantly increase the
estimated size of the total market for WIC
foods.
TABLE 17.—ESTIMATED TOTAL ANNUAL SALES, WIC SALES, AND WIC PERCENT OF MARKET FOR CURRENT FOOD PACKAGE AND INTERIM FOOD PACKAGE, ASSUMING FULL SUBSTITUTION OF WIC FOODS IN TOTAL ANNUAL SALES,
CY2005
Current food package
Estimated total annual sales
($)
Formula ............................
Beans ...............................
Peanut butter ...................
Milk ...................................
Adult cereal ......................
Juice .................................
Rice ..................................
Fruit and vegetables ........
Eggs .................................
Cheese .............................
Bread ................................
Canned fish ......................
Infant cereal 68 .................
Baby food 68 .....................
Tofu 68 ..............................
Soy beverage 68 ...............
pwalker on PROD1PC71 with RULES2
WIC food item
3,600,257,587
874,176,643
1,133,273,041
16,043,036,006
9,697,058,781
14,203,760,671
737,198,377
15,761,934,300
2,959,401,900
12,329,016,799
17,028,860,749
1,917,928,393
..................................
..................................
..................................
..................................
61 United Soybean Board, Current Knowledge on
Soy and Children’s Diets, August 2004, prepared by
N. Chapman and Associates. https://
www.soyfoods.org/wp-content/uploads/2006/11/
soy_and_child_diet.pdf.
62 Mary Kay Fox, William Hamilton, Biing-Hwan
Lin, Effects of Food Assistance and Nutrition
Programs on Nutrition and Health, Volume 3,
Literature Review, Economic Research Service, U.S.
Department of Agriculture, Food Assistance and
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Interim food package
Estimated total WIC
sales
($) 66
WIC % of
market 67
Estimated total annual sales
($)
2,533,590,541
32,179,354
40,935,940
975,287,323
399,336,655
556,756,383
0
7,512,820
120,241,255
386,210,204
0
9,191,549
56,640,143
0
0
0
70.4
3.7
3.6
6.1
4.1
3.9
................
0.0
4.1
3.1
................
0.5
................
................
................
................
3,600,257,587
874,176,643
1,133,273,041
16,043,036,006
9,697,058,781
14,203,760,671
737,198,377
15,761,934,300
2,959,401,900
12,329,016,799
17,028,860,749
1,917,928,393
..................................
..................................
..................................
..................................
Nutrition Research Report Number 19–3. October
2004.
63 WIC sales refer only to sales produced by the
use of WIC vouchers, not the total sales from all
purchases made by WIC participants.
64 Prescription amounts used in this market share
analysis are the same as those used in the cost
analysis.
65 Total annual sales include foods that fit in the
category of food product, but may not be WIC
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Estimated total WIC
sales
($)
WIC % of
market 67
2,025,525,861
82,632,904
54,492,515
712,840,678
399,336,655
281,143,313
43,442,898
431,691,818
67,192,054
247,273,210
93,740,564
10,885,456
42,641,463
185,899,515
1,088,288
49,561,168
56.3
9.5
4.8
4.4
4.1
2.0
5.9
2.7
2.3
2.0
0.6
0.6
................
................
................
................
eligible (i.e., within cereal, total sales include
cereals of any sugar content and cereals without
whole grains). This was done to accurately portray
the impact of the proposed food package on the
whole market and not just the narrow sub-market
of ‘‘WIC eligible’’ food. Because AC Nielsen
Productscan data covers approximately 70% of the
total grocery market, total annual sales were
adjusted by dividing by 70%.
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69029
TABLE 17.—ESTIMATED TOTAL ANNUAL SALES, WIC SALES, AND WIC PERCENT OF MARKET FOR CURRENT FOOD PACKAGE AND INTERIM FOOD PACKAGE, ASSUMING FULL SUBSTITUTION OF WIC FOODS IN TOTAL ANNUAL SALES,
CY2005—Continued
Current food package
WIC food item
Estimated total annual sales
($)
Total ..........................
Interim food package
Estimated total WIC
sales
($) 66
96,285,903,247
WIC % of
market 67
5,117,882,167
6.4
Estimated total annual sales
($)
Estimated total WIC
sales
($)
WIC % of
market 67
4,729,388,359
4.6
96,285,903,247
TABLE 18.—ESTIMATED TOTAL ANNUAL SALES, WIC SALES, AND WIC PERCENT OF MARKET FOR CURRENT FOOD
PACKAGE AND INTERIM FOOD PACKAGE, ASSUMING NO SUBSTITUTION OF WIC FOODS IN TOTAL ANNUAL SALES, CY2005
Current Food Package
WIC food item
Estimated total annual sales
($)
Formula ............................
Beans ...............................
Peanut butter ...................
Milk ...................................
Adult cereal ......................
Juice .................................
Rice ..................................
Fruit and vegetables ........
Eggs .................................
Cheese .............................
Bread ................................
Canned fish ......................
Infant cereal 71 .................
Baby food 71 .....................
Tofu 71 ..............................
Soy beverage) 71 ..............
Total ..........................
Interim food package
Estimated total WIC
sales
($)
WIC % of
market 70
0.0
4.1
3.1
................
0.5
................
................
................
................
3,092,192,907
924,630,192
1,146,829,616
15,780,589,361
9,697,058,781
13,928,147,601
780,641,275
16,186,113,298
2,906,352,699
12,190,079,804
17,122,601,313
1,919,622,300
..................................
..................................
..................................
..................................
2,025,525,861
82,632,904
54,492,515
712,840,678
399,336,655
281,143,313
43,442,898
431,691,818
67,192,054
247,273,210
93,740,564
10,885,456
42,641,463
185,899,515
1,088,288
49,561,168
65.5
8.9
4.8
4.5
4.1
2.0
5.6
2.7
2.3
2.0
0.5
0.6
6.4
95,674,859,149
4,729,388,359
4.7
Estimated total WIC
sales
($) 69
WIC % of
market 70
3,600,257,587
874,176,643
1,133,273,041
16,043,036,006
9,697,058,781
14,203,760,671
737,198,377
15,761,934,300
2,959,401,900
12,329,016,799
17,028,860,749
1,917,928,393
..................................
..................................
..................................
..................................
2,533,590,541
32,179,354
40,935,940
975,287,323
399,336,655
556,756,383
0
7,512,820
120,241,255
386,210,204
0
9,191,549
56,640,143
0
0
0
70.4
3.7
3.6
6.1
4.1
3.9
96,285,903,247
5,117,882,167
Estimated total annual sales
($)
pwalker on PROD1PC71 with RULES2
It is important to note that the numbers in
Tables 17 and 18 differ from the costs
reported in Table 3 mainly because the
market analysis uses pre-rebate formula and
cereal costs as compared to the cost estimate
which factors in the post-rebate savings. In
addition, the data in the market impact
analysis is based on 2005 participation,
whereas the cost estimate uses the projected
participation estimates for 2008 and beyond.
Finally, the market analysis does not take
into account any phase-in period.
Overall, the changes in the WIC food
package will have a modest impact on WIC
sales as a percentage of total annual sales of
these food item categories. Market shares are
slightly higher under the no substitution
scenario. (See Table 17.) For the foods that
are currently part of the food package, the
interim food package has the largest dollar
impact on the infant formula and beans
markets. Under the interim food package, the
market share of WIC sales for infant formula
is less than with the current food package.
The decline is mostly due to a reduction in
the maximum allowance of infant formula for
partially breastfed and fully formula-fed
infants 6 through 11 months of age (Food
Package II FF). The market share of beans
will increase from 3.7% to 8.9%–9.5%. The
majority of this impact stems from the fact
that participants can now substitute canned
beans, which are more expensive, for dried
beans.
The other markets that will be impacted
and are currently part of the food package are
the milk, juice, eggs, cheese, peanut butter,
and fruit and vegetable markets. The market
share of these items will change slightly. The
items that will have decreases are milk, juice,
eggs, and cheese, while the items that will
have increases are peanut butter, and fruits
and vegetables. The WIC market share of
milk will change from 6.1% to 4.4%–4.5%
due to lower prescription amounts and the
ability of participants to substitute tofu, and
soy beverage for fluid milk. The decline in
cheese is also due to these reasons. The share
of the juice market shifts from 3.9% to 2.0%,
66 Total WIC sales reported here are less than the
$5.3 billion (pre-rebate) reported in WIC 2005 food
costs. The estimates of total WIC food sales for the
current and proposed packages are likely to be
lower than actual WIC food expenditures because
the AC Nielsen Productscan and Homescan data
used to estimate food prices may not fully capture
the higher prices charged by WIC vendors such as
small, non-chain, convenience and ‘‘WIC-Only’’
stores.
67 ‘‘WIC % of Market’’ estimates are calculated
only for items for which we have both a numerator
and denominator.
68 We were unable to assess the market impact of
infant cereal, baby food, tofu and soy beverage
items in the WIC food package. These items are not
included in the Productscan data; however, we are
able to estimate WIC sales because these items are
part of the Homescan data, which is our source for
item price data.
69 Total WIC sales reported here are less than the
$5.3 billion dollars (pre-rebate) reported in WIC
2005 food costs. The estimates of total WIC food
sales for the current and proposed packages are
likely to be lower than actual WIC food
expenditures because the AC Nielsen Productscan
and Homescan data used to estimate food prices
may not fully capture the higher prices charged by
WIC vendors such as small, non-chain, convenience
and ‘‘WIC-Only’’ stores.
70 ‘‘WIC% of Market’’ estimates are calculated
only for items for which we have both a numerator
and denominator.
71 We were unable to assess the market impact of
infant cereal, baby food, tofu and soy beverage
items in the WIC food package. These items are not
included in the Productscan data; however, we are
able to estimate WIC sales because these items are
part of the Homescan data, which is our source for
item price data.
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
while the share of the egg market shifts from
4.1% to 2.3%. Both of these declines stem
from changes in the package that are
designed to improve the overall nutritional
benefit of the package. Participants will be
receiving less juice, but more fruits and
vegetables. The amount of eggs will be
lowered consistent with recommendations of
the IOM on cholesterol intake and to permit
a wider variety of foods to be included in the
WIC food packages. The market share of
peanut butter will increase from 3.6% to
4.8%. Lastly, the WIC percent of the fruit and
vegetable market will increase from 0% to
2.7%. This is due to the fact that the only
fruit or vegetable that WIC participants
currently receive are carrots and only
exclusively breastfeeding mothers receive
them. Under the new rule, the fruit and
vegetable vouchers will encourage WIC’s
women and children participants to consume
these foods.
For the foods being added to the WIC food
package, the WIC market share percentages
are, for the most part, small, 0.5%–0.6% and
5.6%–5.9%, for bread and rice, respectively.
We were unable to assess the market impact
of baby food, infant cereal, tofu and soy
beverage. These items are not included in the
Productscan data; however, we are able to
estimate WIC sales because these items are
part of the Homescan data, which is our
source for item price data.
Given the changes in market share and
potential changes in total market demand,
changes in the purchases of WIC-provided
foods could theoretically have an impact on
prices for WIC foods. However, because the
demand impacts for most foods are small and
impossible to estimate precisely, we are
unable to determine the potential price
effects.
WIC purchases of infant formula represent
a larger share of the total market of WICprovided foods than do WIC purchases of the
other WIC foods. The Economic Research
Service (ERS) recently studied the
relationship between retail prices of infant
formula and demand for WIC-provided
formula. ERS findings suggest that the
amount of WIC-provided formula purchased
has an effect on retail prices; specifically,
larger WIC demand leads to higher retail
prices for non-WIC consumers who purchase
the state’s contract brand of formula.72 ERS
estimates, for example, that a non-WIC family
in a State whose WIC program serves twothirds of all formula fed infants would spend
roughly $3 to $5 more, per month, on
contract brand powder formula for their child
than a family in a State whose WIC program
serves just half of formula-fed infants.
However, it is difficult to project the exact
impact of the reduction in WIC demand for
infant formula under the interim rule based
on this study. The ERS analysis was limited
to formulas sold in supermarkets, whereas
projecting the impact of the rule on overall
demand would require an analysis of the
behavior of non-WIC consumers, which have
more diverse purchasing habits. For instance,
many non-WIC formula purchases are at
prices below that of supermarkets from mass
merchandisers that do not participate in the
WIC Program. In addition, the change in WIC
formula sales as a percentage of retail grocery
sales due to this interim rule (from 70.4% to
56.3%–65.5%) is smaller than the changes in
WIC sales examined in the ERS report (from
50% to 66%).
Appendix A: Additional Cost Estimate
Assumptions
TABLE A1.—FY 08 FOOD PACKAGE COSTS
[Monthly costs, post-rebate]
Food package
Current
I—0 to 5.9 month infants 73 .....................................................................................................................................................
II—6 to 11.9 month infants ......................................................................................................................................................
III—Participants with qualifying conditions 74 ..........................................................................................................................
IV—Children 1 to 4.9 years .....................................................................................................................................................
V—Women: Pregnant and partially breastfeeding ..................................................................................................................
VI—Women: Postpartum .........................................................................................................................................................
VII—Women: Fully breastfeeding ............................................................................................................................................
$24.49
33.32
0.00
35.18
39.82
32.15
51.23
Interim
$20.84
41.06
21.07
34.49
42.66
33.38
54.56
TABLE A2.—ANNUAL CURRENT FOOD PACKAGE COSTS (POST-REBATE) FY08–FY12
[In $ millions]
FY08 75
Food package
pwalker on PROD1PC71 with RULES2
I ................................................................................................................
II ...............................................................................................................
III 74 ..........................................................................................................
IV ..............................................................................................................
V ...............................................................................................................
VI ..............................................................................................................
VII .............................................................................................................
72 Victor Oliveira, Mark Prell, David Smallwood,
˜
Elizabeth Frazao, WIC and the Retail Price of Infant
Formula, Economic Research Service, U.S.
Department of Agriculture, May 2004, p. 60.
73 To permit a direct comparison against the
current rule, average food package costs under the
current rule are weighted by the number of children
who fall into the age categories that correspond to
the interim rule food packages. Although the
current cost figures for infants do not correspond
to the food package definitions under the interim
rule, the average costs of foods prescribed to infants
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FY09
$272.18
331.53
0.00
1,454.11
456.17
206.42
169.47
FY10
FY11
FY12
$342.02
416.59
0.00
1,827.21
573.22
259.39
212.95
$357.69
435.68
0.00
1,910.94
599.49
271.27
222.71
$373.79
455.29
0.00
1,996.95
626.47
283.48
232.74
$390.35
475.46
0.00
2,085.41
654.22
296.04
243.05
within the stated age categories are correct. That is,
the cost of monthly food prescriptions to infants up
to 5 months old is lower under the interim rule by
approximately $3.60.
[Current Food Package I is for infants 0–3.9
months of age; interim Food Package I is for infants
0–5.9 months of age. Current Food Package II is for
infants 4–11.9 months of age; interim Food Package
II is for infants 6–11.9 months of age. Food package
costs are weighted by the respective age groups as
shown in Tables D and E in Appendix A.]
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74 Current Food Package III is $0 because the
analysis only considers the incremental costs
associated with the proposal. Interim Food Package
III represents the incremental costs as a result of the
changes in the proposed rule. FNS does not have
comprehensive data on the current cost of medical
foods provided in Food Package III. However, the
medical foods associated with this package are
assumed to stay the same under the current and
interim rules. The incremental cost is extending
foods from other packages to Food Package III
recipients.
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69031
TABLE A3.—ANNUAL INTERIM FOOD PACKAGE COSTS (POST-REBATE) FY08–FY12
[In $ millions]
FY08 75
Food package
I ................................................................................................................
II ...............................................................................................................
III 74 ..........................................................................................................
IV ..............................................................................................................
V ...............................................................................................................
VI ..............................................................................................................
VII .............................................................................................................
TABLE B.—CY05 TO FY06 PRICE IN
FLATION ASSUMPTIONS—FOOD SPECIFIC CPIS
Inflation rate
(percent)
Food item
Infant Formula ..........................
Infant cereal ..............................
Infant food fruit and vegetables
Infant food meat .......................
Bananas ....................................
Milk:
Whole ....................................
Reduced fat ...........................
Cheese .....................................
Yogurt .......................................
Tofu ...........................................
Soy beverage ...........................
1.3
¥1.7
2.5
2.5
4.2
¥0.7
¥0.5
¥0.9
¥0.3
1.3
1.3
FY09
FY11
FY12
$297.59
500.78
10.64
1,756.20
594.06
259.75
219.70
$259.58
355.40
3.02
1,435.66
462.71
206.88
171.61
FY10
$304.29
536.88
12.79
1,818.93
622.09
270.33
229.93
$317.98
561.05
13.36
1,894.24
647.66
281.14
239.41
$332.07
585.90
13.95
1,971.64
673.95
292.25
249.14
TABLE B.—CY05 TO FY06 PRICE INFLATION ASSUMPTIONS—FOOD SPECIFIC CPIS—Continued
TABLE C.—INFLATION ASSUMPTIONS,
FY05–FY12
Inflation rate
(percent)
Food item
Juice .........................................
Adult cereal:
Whole grain ...........................
Current WIC cereals .............
Eggs ..........................................
Beans:
Dry .........................................
Canned ..................................
Peanut butter ............................
Whole grain bread ....................
Brown rice .................................
Tuna ..........................................
Canned Fish .............................
Carrots ......................................
3.9
¥1.7
¥1.7
2.9
1.0
1.0
0.9
3.2
3.7
2.5
2.5
3.4
Year
Thrifty food
plan
(% change)
CPI: fruit
and
vegetables
(% change)
¥0.32
¥0.75
2.05
2.62
2.58
2.45
2.37
2.30
3.74
4.76
1.03
1.96
1.88
1.92
1.92
1.92
FY05 * ...............
FY06 * ...............
FY07 * ...............
FY08 .................
FY09 .................
FY10 .................
FY11 .................
FY12 .................
*Actual WIC Food Package Inflation as of
January 2007.
TABLE D.—PROJECTED PARTICIPATION IN THE WIC PROGRAM, BY FOOD PACKAGE TYPE: CURRENT PACKAGES
Food package
FY08
I
0–3.9 month Infants:
Fully formula-fed ...........................................................
Partially breast-fed ........................................................
Fully breast-fed .............................................................
FY09
FY10
FY11
FY12
435,882
115,169
204,159
444,956
117,567
208,409
454,218
120,014
212,747
463,674
122,513
217,176
Subtotal ..................................................................
II
4–5.9 month Infants:
Fully formula-fed ...........................................................
Partially breast-fed ........................................................
Fully breast-fed .............................................................
6–11.9 month Infants:
Fully formula-fed ...........................................................
Partially breast-fed ........................................................
Fully breast-fed .............................................................
pwalker on PROD1PC71 with RULES2
426,994
112,821
199,996
739,810
755,211
770,932
786,980
803,362
283,539
31,566
56,262
289,441
32,223
57,433
295,466
32,894
58,628
301,617
33,579
59,849
307,895
34,278
61,095
840,456
56,380
98,114
857,952
57,554
100,156
875,811
58,752
102,241
894,043
59,975
104,369
912,654
61,224
106,542
Subtotal ..................................................................
III
Participants with qualifying conditions 76 .............................
IV
Children: 1–4.9 years ...........................................................
V
Women:
Pregnant .......................................................................
Partially breastfeeding ..................................................
1,366,316
1,394,759
1,423,793
1,453,432
1,483,687
92,470
94,395
96,360
98,366
100,414
4,133,746
4,219,798
4,307,640
4,397,311
4,488,849
958,254
187,421
978,202
191,323
998,564
195,305
1,019,351
199,371
1,040,571
203,521
Subtotal ..................................................................
1,145,675
1,169,524
1,193,870
1,218,722
1,244,092
75 For both the current and interim rules, FY 08
figures represent just 10 months (the interim rule
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interim rule figures are not fully phased-in until FY
2010.
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Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 / Rules and Regulations
TABLE D.—PROJECTED PARTICIPATION IN THE WIC PROGRAM, BY FOOD PACKAGE TYPE: CURRENT PACKAGES—
Continued
Food package
FY08
VI
Women: Postpartum ............................................................
VII
Women: Fully breastfeeding ................................................
FY09
FY10
FY11
FY12
642,045
669,054
682,981
697,198
330,813
337,700
344,730
351,906
359,231
8,450,876
Total .......................................................................
655,410
8,626,796
8,806,378
8,989,698
9,176,834
TABLE E.—PROJECTED PARTICIPATION IN THE WIC PROGRAM, BY FOOD PACKAGE TYPE: INTERIM RULE
Food package
FY08
FY09
FY10
FY11
FY12
I
0–3.9 month Infants:
Fully formula-fed ...........................................................
Partially breast-fed ........................................................
Fully breast-fed .............................................................
4–5.9 month Infants:
Fully formula-fed ...........................................................
Partially breast-fed ........................................................
Fully breast-fed .............................................................
.
........................
........................
........................
........................
........................
426,994
112,821
199,996
435,882
115,169
204,159
444,956
117,567
208,409
454,218
120,014
212,747
463,674
122,513
217,176
283,539
31,566
56,262
289,441
32,223
57,433
295,466
32,894
58,628
301,617
33,579
59,849
307,895
34,278
61,095
Subtotal ..................................................................
II
6–11.9 month Infants:
Fully formula-fed ...........................................................
Partially breast-fed ........................................................
Fully breast-fed .............................................................
1,111,176
1,134,307
1,157,920
1,182,024
1,206,630
840,456
56,380
98,114
857,952
57,554
100,156
875,811
58,752
102,241
894,043
59,975
104,369
912,654
61,224
106,542
Subtotal ..................................................................
III
Participants with qualifying conditions 76
IV
Children:
1–1.9 years ...................................................................
2–4.9 years ...................................................................
994,950
1,015,662
1,036,805
1,058,387
1,080,420 *
92,470
94,395
96,360
98,366
100,414
1,364,955
2,768,791
1,393,369
2,826,428
1,422,374
2,885,265
1,451,984
2,945,327
1,482,209
3,006,639
4,133,746
4,219,798
4,307,640
4,397,311
4,488,849
958,254
187,421
978,202
191,323
998,564
195,305
1,019,351
199,371
1,040,571
203,521
Subtotal ..................................................................
VI
Women: Postpartum
VII
.
1,145,675
1,169,524
1,193,870
1,218,722
1,244,092
642,045
655,410
669,054
682,981
697,198
Women: Fully breastfeeding
Total .......................................................................
330,813
8,450,876
337,700
8,626,796
344,730
8,806,378
351,906
8,989,698
359,231
9,176,834
Subtotal ..................................................................
V
Women:
Pregnant .......................................................................
Partially breastfeeding ..................................................
[FR Doc. E7–23033 Filed 12–5–07; 8:45 am]
pwalker on PROD1PC71 with RULES2
BILLING CODE 3410–30–P
76 The interim rule moves infants with qualifying
medical conditions from Food Packages I and II to
a revised Food Package III. The number of Package
III beneficiaries shown here includes those who are
reassigned to Package III as a result of the interim
rule. Individuals who are currently Package III
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20:58 Dec 05, 2007
Jkt 214001
recipients, and those who are newly moved to
Package III by the interim rule, are affected
differently by the interim rule than are other
participants. The current and newly assigned
Package III recipients are also handled differently
than other participants throughout this cost
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analysis. For purposes of clarity and consistency,
all of these individuals are shown as Package III
recipients from the first through the final steps of
the analysis.
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Agencies
[Federal Register Volume 72, Number 234 (Thursday, December 6, 2007)]
[Rules and Regulations]
[Pages 68966-69032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23033]
[[Page 68965]]
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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; Interim Rule
Federal Register / Vol. 72, No. 234 / Thursday, December 6, 2007 /
Rules and Regulations
[[Page 68966]]
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DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
7 CFR Part 246
[FNS-2006-0037]
RIN 0584-AD77
Special Supplemental Nutrition Program for Women, Infants and
Children (WIC): Revisions in the WIC Food Packages
AGENCY: Food and Nutrition Service, USDA.
ACTION: Interim rule.
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SUMMARY: This interim rule revises regulations governing the WIC food
packages to align the WIC food packages with the Dietary Guidelines for
Americans (DGA) \1\ and current infant feeding practice guidelines of
the American Academy of Pediatrics, better promote and support the
establishment of successful long-term breastfeeding, provide WIC
participants with a wider variety of food, and provide WIC State
agencies with greater flexibility in prescribing food packages to
accommodate participants with cultural food preferences.
DATES: Effective Date: This rule is effective February 4, 2008.
Implementation Date: State agencies must implement the provisions
of this rule no later than August 5, 2009.
Comment Date: To be considered, comments on this interim rule must
be postmarked on or before February 1, 2010.
ADDRESSES: The Food and Nutrition Service (FNS) invites interested
persons to submit comments on this interim rule. Comments may be
submitted by any of the following methods:
Federal eRulemaking Portal: Go to https://
www.regulations.gov, select ``Food and Nutrition Service,'' from the
agency drop-down menu, then click ``Submit.'' In the Docket ID column,
select FNS-2006-0037 to submit or view public comments and to view
supporting and related materials available electronically. Information
on using Regulations.gov, including instructions for accessing
documents, submitting comments, and viewing the docket after the close
of the comment period, is available through the site's ``User Tips''
link.
Mail: Send comments to Patricia N. Daniels, Director,
Supplemental Food Programs Division, Food and Nutrition Service, USDA,
3101 Park Center Drive, Room 528, Alexandria, Virginia 22302, (703)
305-2746.
Comments submitted in response to this interim rule will be
included in the record and will be made available to the public. Please
be advised that the substance of the comments and the identities of the
individuals or entities submitting the comments will be subject to
public disclosure. FNS will make the comments publicly available on the
Internet via https://www.regulations.gov. Information regarding the
interim rule will be available on the FNS Web site at https://
www.fns.usda.gov/wic. A regulatory impact analysis has been prepared
for this rule. It follows this regulation as an Appendix.
FOR FURTHER INFORMATION CONTACT: Debra Whitford, Chief, Policy and
Program Development Branch, Supplemental Food Programs Division,
Supplemental Food Programs Division, Food and Nutrition Service, USDA,
3101 Park Center Drive, Room 528, Alexandria, Virginia 22302, (703)
305-2746, or Debbie.Whitford@fns.usda.gov.
SUPPLEMENTARY INFORMATION:
I. Overview
This interim rule implements the first comprehensive revisions to
the WIC food packages since 1980. These revised food packages were
developed to better reflect current nutrition science and dietary
recommendations than do current food packages, within the parameters of
current program costs.
II. Background
The WIC food packages provide supplemental foods designed to
address the nutritional needs of low-income pregnant, breastfeeding,
non-breastfeeding postpartum women, infants and children up to five
years of age who are at nutritional risk. WIC food packages and
nutrition education are the chief means by which WIC affects the
dietary quality and habits of participants. WIC is a unique nutrition
assistance program in that it also serves as an adjunct to good health
care during critical times of growth and development to prevent the
occurrence of health problems and to improve the health status of
Program participants. WIC was never intended to be a primary source of
food, nor of general food assistance. Rather, WIC food benefits are
scientifically-based and intended to address the supplemental
nutritional needs of a specific population--low income pregnant,
breastfeeding, non-breastfeeding postpartum women, infants and children
up to five years of age who are at nutritional risk. In addition to
WIC, the Food and Nutrition Service (FNS) administers a variety of
other complementary nutrition assistance programs that work together to
provide a more complete diet to low-income persons. Low-income families
can, and frequently do, receive benefits from more than one of these
programs. The largest of these programs, the Food Stamp Program,
provides general food assistance intended to increase the food buying
power of low-income households.
The ability of the WIC food packages to reinforce nutrition
education messages provided to participants is critical to affecting
the dietary quality and habits of infants, children and mothers served
by WIC. The nutrition education provided by WIC enables participants to
make informed decisions in choosing foods that, together with the
supplemental foods contained in the WIC food packages, can meet their
total dietary needs. The intent is to help participants continue
healthful dietary practices after leaving the Program.
Since the creation of the WIC Program in the 1970s, and the last
major revision of the WIC food packages in the early 1980's, much has
been learned about the nutritional needs of Americans, including WIC's
target population of pregnant and postpartum women, infants, and
preschool aged children. In recent years the ability of the WIC Program
to address the supplemental nutritional needs of WIC participants
through its food packages and nutrition education has received growing
attention. Significant interest in updating the food packages based on
new information about the needs of low-income, culturally diverse
women, infants, and children has been voiced by WIC Program
administrators, the medical and scientific communities, advocacy
groups, and Congress.
III. General Summary of Comments Received on the Proposed Rule To
Revise the WIC Food Packages
The Proposed Rule to revise regulations pertaining to the
supplemental foods provided through the WIC Program was published in
the Federal Register on August 7, 2006 (71 FR 44784), with a 90-day
comment period. The proposed rule largely reflected recommendations
made by the National Academies' Institute of Medicine (IOM) in its
Report ``WIC Food Packages--Time for a Change,'' \(2)\ with
modifications found necessary by FNS to ensure cost neutrality.
A total of 46,502 comment letters were received on the Proposed
Rule; of those, 23,908 were form letters. A total of 38,257 letters
were received from program participants; 18,080 of those were form
letters. The remaining comment letters were submitted from a
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variety of sources, including WIC State and local agencies and Indian
Tribal Organizations, the National WIC Association (NWA), professional
organizations and associations, advocacy groups, healthcare
professionals (including universities), members of Congress, the food
industry, vendors, farmers, and private citizens.
In general, the proposed changes to the WIC food packages garnered
broad support from public commenters. A total of 21,042 commenters
(8,293 of these form letters) made explicit statements regarding the
merits of the proposed rule as a whole. Of those, 20,438 (8,292 of
which were form letters) expressed support for the majority of the
proposed revisions. A total of 604 commenters (1 of these a form
letter) disagreed with the majority of the proposed rule provisions--
these letters were primarily from participants who did not want to see
any changes to the current WIC food packages. FNS considered all
comments without regard to whether they were provided by a single
commenter or repeated by many. Importance was given to the substance or
content of the comment, rather than the number of times a comment was
submitted.
IV. Discussion of the Proposed Provisions
The following is a discussion of the major provisions set forth in
the proposed rule, a brief summary of the comments received that
addressed these issues, and FNS' rationale for either modifying each
section in the interim rule, or retaining its provisions as initially
proposed. Provisions not addressed in the preamble to this interim rule
did not receive significant or substantial public comments and are
retained in this interim rule as proposed.
This preamble articulates the basis and purpose behind significant
changes from the August 7, 2006, proposal. The reasons supporting
provisions of the proposed regulations were carefully examined in light
of the comments to determine the continued applicability of the
justifications. Unless otherwise stated, or unless inconsistent with
the interim rule or this preamble, the rationales contained in the
preamble to the proposed regulations should be regarded as a basis for
the interim rule. Therefore, a thorough understanding of the rationales
for the interim regulations may require reference to the preamble of
the August 7, 2006 proposal (71 FR 44784).
A. Definitions
1. Participation. FNS proposed to revise the definition for WIC
``participation'' to include the number of breastfeeding women who
receive no supplemental foods or food instruments but whose breastfed
infant(s) receives the supplemental foods or food instruments. The
definition means, therefore, that a partially breastfeeding woman who
requests, after the sixth month postpartum, more than the maximum
amount of formula allowed for a partially breastfed infant would no
longer receive a food package but would continue to count as a WIC
participant and receive other Program benefits and nutrition services
(nutrition education, including breastfeeding promotion and support,
and referrals to health and social services.) Thirty-two commenters (15
form letters) were opposed to not providing a food package to partially
breastfeeding women who request, after the sixth month postpartum, more
formula than the maximum.
The IOM recommended that a partially breastfeeding woman who
requests, after the sixth month postpartum, more than the maximum
amount of formula for a partially breastfed infant, no longer be
certified for the WIC Program. However, FNS determined that this
approach is incongruous with the definition of breastfeeding in WIC
regulations at 7 CFR 246.2--the practice of feeding a mother's
breastmilk to her infant(s) on the average of at least once per day. In
WIC, this definition is used to determine Program eligibility, and
allows all breastfeeding women, regardless of feeding pattern, to
participate in the WIC Program, be counted as a breastfeeding woman,
and receive supplemental foods, breastfeeding promotion and support,
and referrals to health care. The definition recognizes that any
breastfeeding, even if only on an average of once a day, provides some
immunological and nutritional benefits that would otherwise not be
provided to an infant. Rather than adopt IOM's recommendation in its
entirety, FNS proposed to revise the definition for WIC
``participation'' to include breastfeeding women who receive no
supplemental foods or food instruments but whose breastfed infant(s)
receives supplemental food or food instruments. Counting these women,
although they are not receiving a food package, is consistent with the
current practice of counting the infants of exclusively breastfeeding
women. Therefore, a partially breastfeeding woman who requests, after
the sixth month postpartum, more than the maximum amount of formula
allowed for a partially breastfed infant would no longer receive a food
package but would continue to count as a WIC participant and receive
other Program benefits (nutrition education, including breastfeeding
promotion and support, and referrals to health and social services).
This would serve to meet the intent of IOM's recommendations within the
context of WIC regulations.
As recommended by some commenters, FNS clarifies that breastfeeding
women who receive no supplemental foods or food instruments but whose
breastfed infant(s) receives the supplemental foods or food instruments
continue to be eligible to receive nutrition services, and breast pumps
are a part of nutrition services. With this clarification, the
definition of participation is retained in this interim rule as
proposed at 7 CFR 246.2.
2. WIC-eligible medical foods. FNS proposed to revise the
definition for ``WIC-eligible medical foods'' to clarify that medical
foods are designed for children 12 months and older and adults and that
WIC-eligible medical foods are not conventional foods, drugs,
flavorings or enzymes. A few commenters disagreed with the proposed
definition for WIC-eligible medical foods stating that the definition
as proposed would exclude infants from receiving certain medical foods
that are appropriate for them such as modular formulas that are not
nutritionally complete but add specific nutrients such as protein, fat,
and carbohydrate. FNS acknowledges that certain medical foods exist
that are appropriate for use by infants and that medically fragile
infants should be included as a participant category in the WIC-
eligible medical food definition. Several other commenters believe that
FNS should rely on Food and Drug Administration (FDA) expertise for the
definition of medical foods since FDA is the regulatory authority for
medical foods. FNS acknowledges FDA's role in the regulation of medical
foods. However, specific requirements for the safety or appropriate use
of medical foods have not yet been established by FDA.
FNS agrees with commenter concerns that the proposed definition for
WIC-eligible medical foods excludes infants as a participant category.
Therefore, the proposed definition for WIC-eligible medical foods is
revised in this interim rule to include infants as a participant
category.
[[Page 68968]]
B. General Provisions That Affect All WIC Food Packages
1. Food Lists
The proposed rule would have continued to require State agencies to
identify brands and package sizes that are acceptable for use in their
States from among those authorized and to provide to local agencies a
list of acceptable foods and their maximum monthly allowances in
accordance with WIC requirements. This provision is retained in this
interim rule at 7 CFR 246.10(b)(2)(i). A conforming amendment in this
interim rule at 7 CFR 246.4 clarifies that a copy of the food list must
be included in the State Plan.
2. Nutrition Tailoring
Current FNS policy allows both categorical and individual nutrition
tailoring of WIC food packages. Categorical nutrition tailoring is the
process of modifying the WIC food packages for participant groups or
subgroups with similar supplemental nutrition needs, based on
scientific nutrition rationale and State established policies. The
proposed rule would have prohibited categorical nutrition tailoring,
but continue to allow individual nutrition tailoring based on the
Competent Professional Authority's assessment of a participant's
supplemental nutrition needs.
A total of 528 commenters (of these, 505 were form letters) agreed
with the proposal to eliminate State authority to categorically tailor
food packages, stating that the careful balance achieved by the IOM's
recommendations to revise the WIC food packages should be maintained.
In contrast, 187 commenters (of these, 151 were form letters) were
opposed to the provision, stating that States need the flexibility to
propose modifications to food packages that respond to rapid changes in
food industry, science, demographics, and other factors.
As discussed at length in the preamble to the proposed rule, the
revised food packages have the potential to address current nutrient
inadequacies and excesses; discrepancies between dietary intake and
dietary guidance; and current and future health-related problems in
WIC's target population. The IOM was also charged with considering the
cultural needs of WIC participants and its recommendations for
revisions to the WIC food packages, and the proposed rule, reflect
those considerations. The IOM had the resources and capacity to conduct
an independent, rigorous scientific review of the nutritional needs of
WIC participants in each category prior to recommending the quantities
and types of WIC foods to address those needs in its Report.\(2)\
Because the IOM based the revisions to the WIC food packages on current
nutrition science, FNS proposed that State agencies would no longer be
authorized to categorically tailor food packages.
FNS believes that State agencies will best be able to meet the
nutritional needs of each WIC participant through nutrition assessment
and individual tailoring of the food package. Therefore, the provision
to disallow State agency proposals to categorically tailor WIC food
packages is retained in this interim rule at 7 CFR 246.10(c). FNS
clarifies that, in addition to having the authority to individually
tailor food packages, State agencies continue to have the authority to
make adjustments to WIC foods for administrative convenience and to
control costs. Such adjustments may involve packaging methods,
container sizes, brands, types and physical forms of WIC foods.
3. Cultural Food Package Proposals
A total of 174 commenters (of these, 149 were form letters) were
opposed to FNS' proposal to no longer consider WIC State agency
requests for cultural food substitutions. Commenters cited the need for
State agencies to have the flexibility to keep pace with demographic
changes in the WIC population.
FNS believes that the increased variety and choice in the
supplemental foods in this interim rule provide State agencies expanded
flexibility in prescribing culturally appropriate packages for diverse
groups. Section 203(c) of Public Law 108-265 amended Section 17(c)(2)
of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by
requiring the Secretary to conduct, as often as necessary, a scientific
review of supplemental foods available under the program and to amend
the foods, as needed, to reflect nutrition science, public health
concerns, and cultural eating patterns. As such, future reviews of the
WIC food packages by FNS will be used to determine the need for
additional cultural accommodations. However, in response to requests by
commenters to allow State agencies the flexibility to meet
unanticipated cultural needs of participants, a new 7 CFR 246.10(i) has
been added to this interim rule that allows State agencies to submit to
FNS a plan for substitution of food(s) to allow for different cultural
eating patterns. The criteria for submitting plans for substitutions
for different cultural eating patterns and the criteria FNS will use to
evaluate such plans are the same as those under current WIC regulations
at 7 CFR 246.10(e).
4. Medical Documentation and Supervision Requirements
Under the proposed rule, medical documentation would have been
required for certain milk alternatives for children and women and for
any supplemental foods authorized in proposed Food Package III. Under
the proposed rule, medical documentation would continue to be required
for any contract brand infant formula that does not meet the
requirements of an infant formula as specified in Table 4 of 7 CFR
246.10(e)(12) of the proposed rule, any non-contract brand infant
formula, any exempt infant formula, or any WIC-eligible medical food.
Under current WIC regulations, the technical requirements for
medical documentation include:
Brand name of the WIC formula prescribed;
Medical diagnosis warranting the WIC formula;
Length of time the prescribed WIC formula is medically
required by the participant; and
Signature (or name, if the initial documentation was
received by telephone) of the requesting health care provider.
Under the proposed rule, additional technical requirements would
have been added as follows:
Contact information for the participant's healthcare
provider making the medical determination;
Date of medical determination;
Name of specific supplemental food(s) to be prescribed;
Amount prescribed per day of WIC formula and/or
supplemental foods;
Qualifying condition that warrants the issuance of the
specific supplemental food(s); and
Length of time the specific supplemental food(s) is
medically required.
A total of 2,107 comment letters (1,945 of these were form letters)
opposed the proposed medical documentation, primarily the documentation
for children to receive soy-based beverage. Commenter's stated that the
medical documentation requirement for soy-based beverage for children
would create barriers to services and undermine FNS' efforts to provide
foods that meet the cultural needs of participants. A small number of
comments received from WIC staff primarily at the local level expressed
concern that requiring medical documentation for the additional
supplemental foods allowed in proposed Food Package III and requiring
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a prescribed amount per day is burdensome to participants, the medical
community and WIC agencies.
FNS understands the potential administrative impact of requiring
medical documentation for the provision of supplemental foods in Food
Package III. However, these medical documentation requirements were
proposed to ensure that the participant's healthcare provider, licensed
in the State to write prescriptions, has determined that the
supplemental foods are not medically contraindicated by the
participant's qualifying condition. Participants that receive Food
Package III are medically fragile and should be under the care of a
healthcare professional for the purpose of close medical supervision
essential for the participant's overall dietary management.
Participants that receive Food Package III have qualifying medical
conditions that preclude or restrict their use of conventional foods.
Requiring medical documentation to include the additional supplemental
foods allowed in proposed Food Package III and requiring an amount
prescribed per day will ensure that the participant's health care
provider is aware that WIC is providing supplemental foods that the
health care provider has determined are not medically contraindicated
by the participant's qualifying medical condition. Requiring the health
care provider to designate an amount of WIC formula and the WIC
supplemental foods allowed in the participant's diet will help the
Certified Professional Authority (CPA) in designing nutrition education
and a food package prescription that is appropriate to the
participant's medical needs.
FNS acknowledges that some additional administrative tasks will
occur because of medical documentation requirements for dairy
alternatives. However, requiring medical documentation for soy-based
beverage for children ensures that a child's health care provider is
aware that the child may be at nutritional risk when milk is replaced
by other foods. The DGA \(1)\ stress the importance of milk consumption
in the development of bone mass for children. The IOM noted that while
soy products may be an appropriate choice for children who cannot
consume milk, soy should not be made available to satisfy participant
preference in the absence of medical need. Therefore, the proposed
provisions for medical documentation for certain milk alternatives for
children and women and for any supplemental foods authorized in
proposed Food Package III are retained in this interim rule at 7 CFR
246.10(d). Proposed provisions related to revised medical documentation
requirements that are not addressed in this preamble did not receive
significant or substantial public comments and are retained in this
interim rule as proposed.
5. Organic Foods
A number of commenters asked FNS to allow organic products within
the authorized categories of foods in the WIC food packages. FNS points
out that some organic forms of WIC-eligible foods meet the nutritional
requirements set forth in current WIC regulations and are therefore
authorized; this interim rule continues to authorize organic forms of
foods that meet minimum nutrition requirements described in Table 4 of
7 CFR 246.10(e)(12). However, WIC State agencies are responsible for
determining the brands and types of foods to authorize on their State
WIC food lists. Some State agencies may allow organic foods on their
foods lists, but this will vary by State. The decision may be
influenced by a number of factors such as cost, product distribution
within a State, and WIC participant acceptance.
C. Supplemental Foods and Food Packages
Note: In the interest of clarity, specific food package issues
are discussed according to food item rather than food package and
then the food package categories are discussed. The order of some of
the topics in this section is modified from the proposed rule for
the purposes of discussion.
1. Fruits and Vegetables in Food Packages III Through VII
The addition of fruits and vegetables to the WIC food packages was
the most welcomed provision of the proposed rule across all commenter
categories. Of the total of 40,026 comment letters that addressed
fruits and vegetables, 39,961 (22,935 of these form letters) were
favorable. The majority of the few opposing comments were from
participants who did not want to see any changes to the current WIC
food packages.
a. Maximum Monthly Allowances
The IOM recommended that fruits and vegetables be provided at
levels of $10 per month for women and $8 per month for children. To
achieve cost neutrality, the proposed rule would have established the
value of fruit and vegetable vouchers at levels of $8 per month for
women and $6 per month for children. A total of 3,166 commenters (2,940
of these form letters) asked FNS to increase the cash-value vouchers to
the level recommended by the IOM so that participants could receive one
additional serving of fruits and vegetables per day. Commenters cited
(1) the important benefits of fruits and vegetables in decreasing high
blood pressure, heart disease, obesity, and cancer; (2) the generally
low consumption of fruits and vegetables among WIC participants; and
(3) the role that WIC can play in helping participants meet the
DGA\(1)\ for fruit and vegetable intake. Commenters urged FNS to seek
additional funds to provide the cash-value vouchers at the level
recommended by IOM.
A total of 692 commenters (562 of these form letters) asked FNS to
consider, at a minimum, increasing the cash-value fruit and vegetable
voucher to $10 for fully breastfeeding women to further enhance the
attractiveness of this package and provide an additional incentive for
women to breastfeed.
While FNS is in full agreement with the IOM and commenters
regarding the benefits of fruits and vegetables for WIC participants,
it is important that revisions to the WIC food packages be cost neutral
to protect the program's ability to serve the greatest number of
eligible women, infants, and children. For fruits and vegetables, the
IOM's intent was to move WIC participants towards some amount of
increased fruit and vegetable consumption and, at the same time,
reinforce the role of the WIC food packages in nutrition education. The
proposed $8 and $6 cash-value fruit and vegetable voucher fulfilled
this intent while ensuring cost neutrality. Therefore, the provision
will be retained in this interim rule as proposed for children and
women in Food Packages III-VI in Table 2 of 7 CFR 246.10(e)(10) and
Table 3 of 7 CFR 246.10(e)(11). However, FNS has considered the
benefits of increasing the value of the vouchers for fully
breastfeeding women and has determined that a $2 increase can be
accomplished while maintaining cost neutrality. This provision is
therefore revised in the interim rule in Table 2 of 7 CFR 246.10(e)(10)
and Table 3 of 7 CFR 246.10(e)(11) to reflect a cash-value voucher of
$10 for fully breastfeeding women in Food Packages III and VII.
Thirty commenters (23 of which were form letters) preferred that a
set amount of fruits and vegetables be authorized per month, e.g., 3
pounds for a child, in lieu of a cash-value voucher, for administrative
ease and to control costs. FNS disagrees with this approach. A voucher,
rather than a more narrowly defined fruit and vegetable option, offers
flexibility, ensures participant access, and minimizes costs of
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compliance by administrative agencies and WIC-approved vendors.
Allowing participants to choose a wide variety of fruits or vegetables
is intended to increase consumption by accommodating individual and
culturally-based preferences.
(1) State agency responsibility to make available to participants
at least two fruits and two vegetables from the category of fruits and
vegetables in each authorized food package. FNS proposed that State
agencies be required to make available at least two fruits and two
vegetables to participants in Food Packages III-VII. A total of 487
commenters (of which 418 were form letters) opposed the provision,
believing that it undermines the IOM's recommendation to allow
participants a wide variety of choices within the authorized fruit and
vegetable options by authorizing State agencies to limit the number and
variety of fruits and vegetables.
FNS' intention with this proposed provision was to ensure
participant choice among the fruit and vegetables authorized by the
State agency by expanding current WIC regulations that require State
agencies to make available at least one food from each group in each
food package. As described in the preamble to the proposed rule, it was
FNS' expectation that more than two varieties each of fruits and
vegetables would be authorized by State agencies. Therefore, the
proposed provision is clarified in the interim rule at 7 CFR
246.10(b)(2)(ii)(B) to ensure its original intent to require State
agencies to allow participants to use their cash value vouchers to
purchase any WIC-eligible fruits and vegetables from among those
authorized in Table 4 of 7 CFR 246.10(e)(12). This allows participants
a wide variety of choices within the authorized fruit and vegetable
options without restriction, in keeping with IOM recommendations.
Further, the proposed provision at 7 CFR 246.10(b)(1)(i) is revised in
this interim rule to disallow further restrictions on eligible fruits
and vegetables.
(2) Minimum vendor stocking requirement. Similarly, at 7 CFR
246.12(g)(3)(i), FNS proposed that WIC authorized vendors carry a
minimum of two varieties of fruits and vegetables to ensure participant
choice at the retail level, while acknowledging that certain smaller
vendors may not be able to stock as wide a variety of fruits and
vegetables as larger vendors. A total of 472 commenters (418 form
letters) disagreed with this provision, stating that setting a minimum
vendor stocking requirement of two fruits and vegetables undermines the
IOM recommendation to allow participants a wide variety of choices. Of
these commenters, 269 (221 form letters) stated that State agencies
should be allowed to specify minimum stocking requirements.
FNS points out that the proposed provision authorizes State
agencies to establish different minimums for different vendor peer
groups, thus allowing State agencies the flexibility to work with
vendors to provide the maximum number and variety of fruits and
vegetables that are locally accessible, culturally appropriate and
affordable. However, it is required that all authorized vendors must
stock at least two varieties of fruits, two varieties of vegetables,
and one whole grain cereal authorized by the State agency. Therefore,
the provision at 7 CFR 246.12(g)(3)(i) is retained in the interim rule
as proposed; however, a technical oversight in the proposed rule has
been corrected by clarifying that authorized vendors must stock at
least two different varieties of fruits and two different varieties of
vegetables.
b. Inflation Adjustment
FNS proposed an option to increase the value of the cash-value
fruit and vegetable vouchers by a whole dollar increment. A total of
124 commenters (75 of which were form letters) asked that FNS commit to
a yearly inflation adjustment. FNS agrees with commenter that it is
important to maintain the value of the vouchers over time. Cash-value
vouchers will be set at $6 for children and $8 for pregnant and
partially breastfeeding and $10 for fully breastfeeding women in the
year in which the food package revisions take effect. This interim rule
adds a provision at 7 CFR 246.16(j) to adjust the maximum value of the
vouchers in whole dollar increments using the Bureau of Labor
Statistics' Consumer Price Index for Fresh Fruits and Vegetables.
c. Minimal Restrictions on Authorized Fresh Fruits and Vegetables
To improve the consumption of fresh fruits and vegetables and to
appeal to participants of different cultural backgrounds, the proposed
rule would have authorized a wide variety of choices within the
authorized fruit and vegetable options. To ensure nutritional integrity
and cost neutrality, some minimal restrictions were proposed, e.g., no
herbs or spices, edible blossoms of flowers, fruit leathers and fruit
roll-ups. The majority of commenters favored the provision to authorize
a wide variety of fruits and vegetables; however, 9 commenters (1 of
which was a form letter) stated the opinion that the fruit and
vegetable selections should be limited to sources of priority
nutrients.
As stated in the Regulatory Impact Analysis that was published in
the Federal Register as an appendix to the proposed rule, FNS
considered alternatives to the proposed provision, including
authorizing a more restrictive dark green and orange vegetable
provision. This alternative was rejected because FNS believes that WIC
food packages that reflect the IOM recommendations as closely as
possible within the constraints of cost neutrality best reflect current
scientific consensus on how to meet the supplemental dietary needs of
WIC participants. The IOM chose not to emphasize the dark green and
orange vegetable groups that tend to offer the highest concentrations
of certain priority nutrients and instead recommended a fruit and
vegetable option with few restrictions. Nutrition education offered by
local WIC agencies will remain the primary method of encouraging
participants to incorporate these high nutrient fruits and vegetables
into their diets; under this interim rule participants remain largely
free to choose the fruits and vegetables that they find most appealing.
Thirteen commenters (2 of which were form letters) believe that FNS
should simplify the proposed minimal restrictions to ease
interpretation and implementation for participants, vendors, and staff.
A total of 128 commenters (125 of which were form letters) asked FNS to
allow State agencies flexibility to promote produce selections that
come in standard packages with Universal Product Codes to minimize
burden. As stated above, the nutrition education provided to
participants is intended not only to encourage participant choice in
the selection of fruits and vegetables, but also to provide information
on shopping tips to obtain the maximum value of the voucher.
FNS is aware that State agencies will need to provide training and
technical assistance to participants and vendors in implementing the
food package changes. State agencies generally update their food lists
on a biennial basis which requires training for both participants and
vendors. Recognizing the extensive changes that will be necessary as a
result of this rule, FNS will assist State agencies on vendor training,
participant education, and other implementation issues. FNS also
encourages State agencies to work with their vendor associations as
they develop their new State procedures, particularly in regard to the
cash-value fruit/vegetable voucher.
[[Page 68971]]
d. Disallowance of White Potatoes
Under the proposed rule, white potatoes would have been excluded
from authorization in the WIC food packages. A total of 324 commenters
(of these 291 were form letters) opposed the restriction of white
potatoes. Twenty-four commenters stated that white potatoes should be
included in the WIC food packages because they are versatile,
economical and contain key nutrients. Thirteen commenters (1 form
letter) from WIC State and local agencies stated that the exclusion of
white potatoes would be hard to administer.
The restriction of white potatoes, as recommended by the IOM, is
based on the amounts suggested in the DGA\(1)\ for consumption of
starchy vegetables; food intake data indicating that consumption of
starchy vegetables meets or exceeds these suggested amounts; and food
intake data showing that white potatoes are the most widely used
vegetable. Therefore, this provision is retained in the interim rule as
proposed in Table 4 of 7 CFR 246.10(e)(12).
e. Implementation of Fruit and Vegetable Options
(1) Small dollar denomination of fruit and vegetable food
instruments. In the preamble to the proposed rule, FNS encouraged State
agencies to issue small denomination, i.e., $2, cash-value fruit and
vegetable food instruments. The small denominations were encouraged so
the participant could obtain small amounts of fresh produce at various
times during the month, lessening the chance of food spoilage and
waste. A total of 200 commenters (of which 133 were form letters)
disagreed with FNS' recommendation to provide the fruit and vegetable
value in small denominations. The majority of those in opposition were
WIC State and local agencies who stated that they should be allowed to
determine, in partnership with vendors, the most cost effective method
to provide the fruit and vegetable food instrument. FNS clarifies that
although State agencies are encouraged to provide the cash-value food
instrument in small denominations for the reasons cited above and in
the proposed rule, State agencies will determine the dollar
denomination that is most beneficial to participants and cost effective
given the State agency's infrastructure and environment.
(2) Paying cash with the fruit/vegetable voucher. Nineteen
commenters asked that participants be allowed to pay the difference
when the purchase exceeds the value of the fruit/vegetable voucher.
Under current rules at 7 CFR 246.12(c), State agencies must ensure that
participants receive their authorized supplemental foods free of
charge. Such a restriction is necessary with the ``traditional'' WIC
food instrument which reflects a specific quantity of foods that a
participant must receive. In contrast, the fruit/vegetable cash-value
voucher reflects a maximum dollar allotment for the participant.
Because it may be difficult to accurately estimate the exact purchase
price of the fruit and vegetable selections, particularly when fresh
and canned or frozen items are combined in one purchase, FNS concurs
with commenters that participants should be allowed to pay the
difference when the purchase of allowable fruits and vegetables exceeds
the value of the fruit/vegetable voucher. This option would promote
increased consumption of fruits and vegetables because participants
would be more likely to utilize the full cash value, rather than
partially redeem the voucher for fear of exceeding its cash value. The
rule prohibits giving cash or credit to the participant for any unused
portion of the fruit/vegetable voucher.
(3) Benefit delivery. While most of the food package changes will
be administered via existing State benefit delivery systems, the cash-
value fruit/vegetable voucher will require changes to WIC benefit
delivery systems to accommodate a more open-ended benefit determined by
a cash value rather than a fixed quantity of a specific food item.
State agencies and vendors must modify operations and procedures to
issue, transact, and process the redemption of a cash value benefit. As
described in the proposed rule, options for benefit delivery include
Electronic Benefit Transfer (EBT) and farmers' markets.
(4) Farmers' markets. A total of 936 commenters (of which 170 were
form letters) agreed with the provision to allow the fruit/vegetable
cash-value voucher to be redeemed by farmers at farmers' markets.
Eleven commenters disagreed with the provision. Many commenters
suggested that FNS ``Do no harm to the WIC Farmers' Market Nutrition
Program (FMNP),'' and that funding for the FMNP not be reduced or
procedures established that would adversely affect its operation or
effectiveness.
FNS would like to clarify that the regulatory requirements for the
FMNP are unchanged by this interim rule. Many commenters incorrectly
believed that the proposal would have allowed FMNP coupons to be
redeemed at authorized WIC vendors. This is not true; the proposal
would have allowed the WIC fruit/vegetable cash-value voucher to be
redeemed at farmers' markets.
Of the commenters supporting the provision to allow farmers at
farmers' markets to accept the fruit/vegetable cash-value voucher,
clarification was requested on several issues--would State agencies be
required to authorize farmers at farmers' markets if they do not
currently administer the FMNP; can farmers at farmers' markets be
treated as seasonal vendors and only be allowed to accept the fruit/
vegetable voucher; can the State agency enter into one contract with
the farmer that includes requirements for both WIC and the FMNP; and,
can farmers' markets be excluded from the WIC vendor monitoring and
audit requirements?
In response to commenter questions, this interim rule will not
require State agencies to authorize farmers to accept the WIC fruit/
vegetable voucher. If a State agency chooses to authorize farmers at
farmers' markets, it may modify its standard vendor agreement to
address the unique circumstances of farmers' markets, as allowed by 7
CFR 246.12(h)(2). For example, the farmer's market agreement may only
allow the farmer to accept the fruit/vegetable cash-value voucher. In
addition, the State agency can choose to enter into one agreement with
the farmer that includes the requirements for both the WIC and WIC
Farmers' Market Nutrition Programs. Further, farmers would be excluded
from the vendor cost containment requirements. The farmers may also be
excluded from the WIC monitoring requirements provided that they are
included in the sample of farmers upon which the FMNP monitoring
requirement is drawn. A new 7 CFR 246.12(v) has been added that
specifies the requirements regarding the authorization of farmers at
farmers' markets. The rule also adds definitions for cash-value voucher
and farmer (the same as that used in the FMNP), and modifies the food
instrument requirements to identify the provisions that do not apply to
the cash-value voucher. As a result of the addition of the definitions
of farmer and cash-value voucher, we have made conforming amendments to
the definitions of ``compliance buy,'' ``employee fraud and abuse,''
``participants,'' ``participant violations,'' ``proxy,'' and
``nutrition services and administration'' to include these new terms as
appropriate.
(5) Electronic Benefit Transfer (EBT). While the majority of State
WIC agencies deliver benefits via paper checks or vouchers, 5 States
are testing the feasibility of EBT and an additional State has adopted
EBT statewide.
[[Page 68972]]
Although it will take a number of years to implement WIC EBT fully in
all States, the fruit and vegetable benefit may provide opportunities
for alternative forms of benefit delivery and allow some States to move
toward limited electronic benefit processing prior to the
implementation of EBT for all WIC purchases. In an effort to explore
the range of possibilities for using existing commercial infrastructure
to administer the fruit and vegetable benefit including WIC EBT
smartcard and online solutions, commercial debit cards, and other
technologies, FNS commissioned a study by the State Information
Technology Consortium (SITC). Although the report is not yet final,
preliminary findings indicate that for redemption of the fruit/
vegetable benefit, paper fruit and vegetable cash-value checks or
vouchers appear to be the least costly and easiest to implement by
State agencies and food vendors within a 12-month time period. The
accountability for purchasing authorized fruits and vegetables remains
the same as other food instruments--subject to training store clerks
regarding eligible food items and State compliance monitoring.
Debit type cards (EBT or credit/debit) with a magnetic strip offer
potentially cost-effective solutions that leverage the widely available
card payment infrastructure in the United States. Magnetic strip cards
in volume can be purchased for less than 25 cents each. There are, for
instance, many large and smaller food vendors that already accept
credit card payments or accept EBT cards using a four digit Personal
Identification Number (PIN). These vendors include most authorized WIC
vendors. Focus groups with participants were favorable to this type of
alternative because of lessened stigma while shopping and the ability
to purchase foods incrementally rather than forfeiting some items with
a paper instrument. Technical standards would need to be modified to
enable card use only within authorized WIC vendor locations and there
may be a need to define standards to facilitate retailer and/or EBT
contractor changes to existing store equipment and software. The
accountability for purchasing eligible foods only is similar to paper
food instruments.
WIC EBT solutions, on-line using magnetic-strip cards or off-line
using smart cards, offer the greatest potential to ensure that only
eligible fruits and vegetables are purchased with WIC cash-value
vouchers, but it would be more costly for all stakeholders. These
solutions would match each item scanned to a State list of authorized
UPC's and/or Price Look-Up codes or PLUs. These solutions require
additional investment by State agencies in cards, equipment, and
maintenance of a much larger number of product Universal Product Codes
and Price Look-Up (PLUs) codes for fresh produce. The fresh produce
industry has taken steps to institute greater standardization of PLUs;
however, the seasonal and local produce suppliers do not always have
means to use PLUs effectively. The draft SITC report suggests that
pilot design and development will be necessary to identify cost
effective solutions that can be widely adopted by State agencies and
authorized vendors.
2. Peanut Butter and Legumes
The proposed rule would have added 18 ounces of peanut butter in
Food Package V to improve the intake of several nutrients in the diets
of pregnant and breastfeeding women. The proposed rule would also add
legumes (dried beans/peas or peanut butter) in Food Package VI for
postpartum women. Canned beans were proposed as an optional substitute
for dry beans in Food Packages III-VII. Of the 3,091 comment letters
that addressed these provisions, 3,085 commenters (21 form letters)--a
large majority of whom were participants--were in favor of the proposed
changes.
Six commenters asked that FNS eliminate peanut butter in the food
packages for children because of concerns about peanut allergies. The
IOM advised that children should avoid eating peanut butter from a
spoon for safety reasons until age 3, but recommended that peanut
butter continue to be offered in the WIC food packages for young
children from 1 to 5 years of age. IOM has advised FNS that assessing
for allergies and tailoring a young child's food package based on such
assessment, as is current practice in WIC, is appropriate.
Therefore, the proposed peanut butter and legume provisions are
retained in this interim rule as proposed.
3. Milk and Milk Alternatives
a. Maximum Monthly Milk Allowances
The proposed rule would have decreased the maximum monthly
allowances for milk in all food packages--for children and postpartum
women, from 24 quarts to 16 quarts; for pregnant and partially
breastfeeding women, from 28 to 22 quarts; and for fully breastfeeding
women, from 28 quarts to 24 quarts of milk. Reducing the amount of milk
provided through WIC is consistent with recommended limits on saturated
fat, total fat, and cholesterol consumption put forth in the DGA,\(1)\
better aligns the amount of milk provided by WIC with the amounts
recommended by the DGA\(1)\ and is consistent with the supplemental
nature of the WIC Program.
The majority of non-participant commenters were in favor of the
proposed reductions in milk. A total of 2,088 non-participant
commenters (1,874 of which were form letters) were supportive of the
reductions, while 66 commenters were opposed. Commenters opposing the
reductions cited the contribution of milk to intakes of priority
nutrients for WIC participants, e.g., calcium, Vitamin A, and
potassium. Seventeen commenters stated that the food package for
postpartum women should be increased to the levels provided to pregnant
and partially breastfeeding women. Six commenters urged FNS to maintain
milk at current levels and increase funding for other proposed food
package provisions.
Comment letters from program participants reflected disappointment
with the reductions in milk. A total of 1,831 comment letters were
received from program participants who opposed the reductions; 225
participants wrote in favor of the proposed reductions.
FNS believes that the IOM set forth a series of science-based
recommendations that, taken together, balance the various supplemental
nutritional needs of participants. According to the IOM, amounts of
milk provided by the WIC food packages need not exceed amounts
recommended by the DGA.\(1)\ The proposed dairy levels for children (2
cups/day) and pregnant and breastfeeding women (3 cups/day) provide at
least 100 percent of the servings recommended by the DGA.\(1)\ The
level for non-breastfeeding postpartum women is at least \2/3\ of the
amount set forth by the DGA.\(1)\ The proposed maximum monthly
allowance of milk allows a more balanced food package to provide the
various high priority nutrients within cost constraints. Therefore, the
proposed maximum allowances for milk are retained in this interim rule
in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11).
b. Low-Fat Milk
Under the proposed rule, only whole milk (not less than 3.25% milk
fat) would have been authorized for children less than 2 years of age.
For children two years of age and older and women, the proposed rule
would have authorized only milk with no more than 2% milk fat to be
consistent with current recommendations of the DGA
[[Page 68973]]
2005 to limit saturated fat and dietary cholesterol intake. A total of
3,058 commenters (2,663 of which were form letters) agreed with the
provisions as written; 222 (10 of which were form letters) were
opposed. One hundred seventy of those opposed were program
participants. A total of 1,379 commenters (1,338 of which were form
letters) stated that the fat content of milk for children and women
should be reduced even further--to no more than 1% of milk fat.
Seventy-eight commenters (23 of which were form letters) asked FNS
to allow the CPA the authority to prescribe the type of milk (whole
milk or low fat milk) to participants, regardless of age or category,
if medically necessary for such reasons as failure to thrive,
underweight or overweight. FNS' position is that participants who have
medical conditions that lead to a diagnosis of failure to thrive will
likely be issued Food Package III. Therefore, to address commenters'
concerns, this interim rule will authorize whole milk for children 1
through 4 years of age and women in Food Package III, with medical
documentation. As proposed, only milk with no more than 2% milk fat is
authorized for children 2 years of age and older and women in Food
Packages IV-VII. For these participants, nutrition education directed
towards appropriate foods and food amounts should be provided for
underweight or overweight participants. Nutrition education and
individual tailoring of the food package within authorized parameters
remain the most effective tools for WIC staff to use to help
participants make appropriate choices based on their specific needs.
c. Lactose Free Milk
Under the proposed rule, as long as a milk conforms to the FDA
standard of identity for milk as defined by 21 CFR Part 131 and meets
WIC Federal requirements, it would be an authorized milk in Food
Packages IV, V, VI, and VII. Although not specified in the proposed
rule, authorized milks that conform to the FDA standard of identity
include, but are not limited to, calcium-fortified, lactose-reduced and
lactose-free, acidified, and ultra-high temperature (UHT) milks. FNS
clarifies that these products are authorized, and that lactose-free or
lactose-reduced dairy products should be offered before non-dairy milk
alternatives to those participants with lactose intolerance who cannot
drink milk. FNS also clarifies that medical documentation is not
required for participants to receive lactose-reduced and lactose-free
milk.
d. Authorized Substitutions for Milk (Cheese, Tofu, Soy-Based Beverage)
(1) Cheese. The proposed rule would have reduced the amount of
cheese that may be substituted for milk to one pound per month for
children and pregnant, postpartum and partially breastfeeding women,
and two pounds for fully breastfeeding women. Reducing the amount of
cheese that may be substituted for milk will reduce saturated fat and
total fat intake by children age two and older and women consistent
with the DGA\(1)\ recommendations. Amounts of cheese that exceed the
maximum substitution amounts may be authorized with medical
documentation in cases of lactose intolerance or other qualifying
conditions.
The majority of non-participant commenters were in favor of the
proposed reduced cheese substitution amounts. A total of 754 non-
participant commenters (of which 589 were form letters) were supportive
of the reduced substitution amounts, while 53 commenters were opposed.
A total of 917 comment letters were received from program participants
who opposed the proposed cheese allowances; 119 participants wrote to
express support for the proposed amounts. Commenters opposing the
cheese substitution amounts stated that cheese is culturally acceptable
to most populations, and provides nutrients in a convenient and
familiar way. Fourteen commenters asked FNS to maintain cheese at its
current substitution levels and emphasize or require reduced-fat
cheese.
Reducing the maximum amount of cheese lowers the amount of
saturated fat, total fat, and cholesterol in the WIC food packages.
Within the context of the proposed revisions to the WIC food packages
as a whole, the reductions in the current levels of cheese ensure that
FNS is able to provide a more balanced nutrient intake for WIC
participants while maintaining cost neutrality. Therefore, the proposed
substitution levels for cheese are retained in this interim rule.
(2) Soy-based beverage and tofu. To provide more flexibility for
WIC State agencies and more variety and choice for WIC participants,
the proposed rule would have authorized soy-based beverage to be
substituted for milk for women in Food Packages V, VI and VII at the
rate of 1 quart of soy-based beverage for 1 quart of milk up to the
total maximum allowance of milk. The proposal also would have allowed
calcium-set tofu to be substituted at the rate of 1 pound of tofu per 1
quart of milk. A maximum of 4 quarts of milk could be substituted in
this manner in Food Packages V and VI, and a maximum of 6 quarts of
milk may be substituted in Food Package VII. Under the proposed rule,
soy-based beverage and tofu would not be allowed as substitutes for
milk for children in Food Package IV without medical documentation. The
qualifying conditions may include, but are not limited to, milk
allergy, severe lactose maldigestion, and vegan diets. Amounts of tofu
that exceed the maximum substitution amounts may be authorized for
women, with medical documentation, in cases of lactose intolerance or
other qualifying conditions.
A total of 8,932 commenters (4,615 form letters) were supportive of
adding soy-based beverage and tofu to the WIC food packages as milk
substitutes; 368 commenters (148 form letters) were not supportive.
Comments received on medical documentation requirements for soy-based
beverage for children and FNS' rationale for retaining the provision in
this interim rule as initially proposed are discussed in section
IV.B.4. of this preamble.
As stated in the preamble to the proposed rule, Section 102 of the
Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-265)
requires that nondairy beverages offered as an alternative to fluid
milk in the National School Lunch Program and School Breakfast Program
must be nutritionally equivalent to fluid milk and meet nutritional
standards set by the Secretary of Agriculture. FNS, therefore, proposed
that authorized soy-based beverage provide, at a minimum, the following
nutrients:
Calcium............................. 276 milligrams (mg) per cup.
Protein............................. 8 grams per cup.
Vitamin A........................... 500 International Units (IU) per
cup.
Vitamin D........................... 100 IU per cup.
Magnesium........................... 24 mg per cup.
Phosphorus.......................... 222 mg per cup.
Potassium........................... 349 mg per cup.
Riboflavin.......................... 0.44 mg per cup.
Vitamin B12......................... 1.1 mcg per cup.
A total of 340 commenters (255 form letters) were opposed to the
proposed minimum nutrient standard, stating that fortification at these
levels is not necessary, and that soy-based beverage meeting the
proposed minimum nutrition standard are not available in the
marketplace. FNS believes that it is imperative for WIC and the school
nutrition programs to use the same standards for defining allowable
soy-based beverage as alternatives to fluid milk. Therefore, the
proposed minimum nutrient standard for soy-based beverage
[[Page 68974]]
is retained in this interim rule. FNS is aware of at least one soy-
based beverage in the marketplace that meets these requirements and
anticipates that the marketplace will respond with additional products.
To the extent that the marketplace doesn't respond with additional
products, other options, such as tofu, are available for participants.
(3) Yogurt. The IOM recommended adding yogurt to the WIC food
packages as a milk substitute for children and women. However, in order
to maintain cost neutrality, the proposed rule did not include yogurt.
Of the 758 commenters that addressed yogurt, 749 (617 form letters)
disagreed with FNS' decision not to include yogurt. Commenters stated
that yogurt provides priority nutrients, and is convenient, popular,
and culturally acceptable to WIC participants.
FNS agrees that yogurt would be a desirable dairy alternative to
milk for WIC participants; however, the cost is simply prohibitive
($413.9 million over 5 years). In addition, FNS has determined that WIC
participants will be able to get the calcium provided by yogurt through
other foods authorized in these revised food packages. Lactose-free and
lactose-reduced dairy products, for example, are readily available in
both urban and rural areas for those WIC participants with lactose
intolerance. Calcium-set tofu and soy-based beverages are available to
accommodate cultural preferences. Also, as noted earlier, a new 7 CFR
246.10(i) has been added to this interim rule to allow State agencies
the flexibility to meet unanticipated cultural needs of participants.
It is important that revisions to the WIC food packages be cost
neutral to protect the program's ability to serve the greatest number
of eligible women, infants, and children. Therefore, FNS is unable to
authorize yogurt in the WIC food packages in this interim final rule.
However, FNS solicits comments from State agencies as they
implement the provisions of this interim rule about the extent to which
WIC participants would benefit from the addition of yogurt, and whether
that addition would be achieved in a cost-effective way. In particular,
we are interested in the impact of adding yogurt for women in Food
Packages V-VII.
FNS also solicits comments as to the feasibility of rebate
agreements between yogurt manufacturers and individual States, so that
yogurt could be provided to specific participant groups in the WIC
program while maintaining cost-neutrality. State agencies are currently
encouraged to explore the feasibility of cost containment systems,
especially rebates, and to implement such a system where feasible for
other WIC foods. In an effort to use their food grants more
efficiently, 13 State agencies, which include 3 multi-State contracts,
have rebate contracts for juice (frozen and shelf), infant juice and/or
infant cereal. If FNS were to consider including yogurt as a WIC-
eligible food through future rulemaking, FNS would be interested in the
following types of information:
Which participant groups would most benefit from having
yogurt included as part of their food package?
Would States be able to secure rebates sufficient enough
to add yogurt for all or certain participant groups while maintaining
cost-neutrality?
Finally, and as noted earlier, Section 203(c) of Public Law 108-265
amended Section 17(c)(2) of the Child Nutrition Act of 1966, as amended
(42 U.S.C. 1786), by requiring the Secretary to conduct, as often as
necessary, a scientific review of supplemental foods available under
the program and to amend the foods, as needed, to reflect nutrition
science, public health concerns, and cultural eating patterns. As such,
future reviews of the WIC food packages by FNS will be used to
determine the need for yogurt.
4. Eggs
Under the proposed rule, the maximum monthly allowance for fresh
shell eggs would have been reduced from the current 2 or 2\1/2\ to 1
dozen fresh shell eggs for children and women in Food Packages IV, V,
and VI. For fully breastfeeding women in Food Package VII, the maximum
monthly allowance was proposed at 2 dozen eggs.
A total of 1,469 commenters (266 of which were form letters)
addressed the proposed egg reduction provision. Of the 492 non-
participant commenters, 406 were in favor of the proposed reductions.
Those opposing stated that eggs provide important nutrients at
relatively low cost. Of the 1,009 program participants who commented,
923 were opposed to the reduction in eggs.
The proposed maximum monthly allowance of eggs is consistent with
recommendations of the IOM \(3)\ and the DGA \(1)\ to reduce
cholesterol. In addition, the IOM determined that protein is no longer
a priority nutrient for the WIC population. Within the context of the
proposed revisions to the WIC food packages a