[Federal Register: December 6, 2007 (Volume 72, Number 234)]
[Rules and Regulations]
[Page 68965-69032]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de07-8]
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Part II
Department of Agriculture
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Food and Nutrition Service
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7 CFR Part 246
Special Supplemental Nutrition Program for Women, Infants and Children
(WIC): Revisions in the WIC Food Packages; Interim Rule
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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 http://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 http://www.regulations.gov Information regarding the interim rule will be available on the FNS Web site at http://.
http://www.fns.usda.gov/wic. A regulatory impact analysis has been prepared
for this rule. It follows this regulation as an Appendix.
FOR FURTHER INFORMATION CONTACT: Debra Whitford, Chief, Policy and
Program Development Branch, Supplemental Food Programs Division,
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.
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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 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 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
[[Page 68975]]
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 http://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 rice-based cereals, as well as severely limit the total
variety and choice of WIC-eligible 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
difficulties in the identification of whole wheat bread and whole grain
cereals by State agency staff when determining which products are WIC-
eligible; 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 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 http://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
[[Page 68976]]
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 may
change package sizes at any time. 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 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 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
long-term breastfeeding among women who choose that feeding method,
address differences in nutritional needs of breastfed and formula fed
infants, address developmental needs of infants, bring the infant food
packages in line with current infant feeding practice guidelines from
the AAP, and serve all participants with certain medical conditions
under one food package to facilitate efficient management of medically
fragile participants.
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
[[Page 68977]]
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.
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 three-pronged 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 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 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
[[Page 68978]]
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
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, 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 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.
[[Page 68979]]
Exhibit A.--Maximum Monthly Allowances for Food Package I for Infants Ages Birth to 6 Months, by Feeding Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fully breastfed Partially breastfed infants Fully formula fed infants
infants ---------------------------------------------------------------------------------------------------
WIC food --------------------
0 through 5 months Birth to one month 1 through 3 months 4 through 5 months 0 through 3 months 4 through 5 months
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infant Formula.................. NA................ 104 fl oz 364 fl oz 442 fl oz 806 fl oz 884 fl oz
reconstituted reconstituted reconstituted reconstituted reconstituted
powder. liquid liquid liquid liquid
concentrate\*\. concentrate. concentrate. 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.
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 non-
participant 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
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 recommended that
the amount of iron-fortified 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 full-authorized 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.
Seventy-seven 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
[[Page 68980]]
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 generally healthy, full-term infants. Infant formula includes milk-
based, soy-based 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 nutritionally-related
medical condition that requires an exempt infant formula or WIC-
eligible 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, http://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 WIC-
eligible 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 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.
[[Page 68981]]
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
------------------------------------------------------------------------
Who must Timeframe for
Food package category implement implementation
------------------------------------------------------------------------
Pregnant Women................ All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Postpartum Women.............. All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Fully Breastfeeding Women..... All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Partially Breastfeeding Women. All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Fully Formula fed Infants..... All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Partially Breastfed Infants... All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Fully Breastfed Infants....... All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Juice Elimination from Infant All State 18 Months from
Food Packages. Agencies. Effective Date of
Interim Rule.
Children...................... All State 18 Months from
Agencies. Effective Date of
Interim Rule.
Participants with Certain All State 18 Months from
Medical Conditions (Women, Agencies. Effective Date of
Infants and Children). Interim Rule.
------------------------------------------------------------------------
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.
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: http://www.healthierus.gov/dietaryguidelines/.
(2) Institute of Medicine, National Academy of Sciences. ``WIC
Food Packages: Time for a Change,'' 2005. Available at Internet
site: http://www.fns.usda.gov/oane/menu/Published/WIC/FILES/Time4AChange
(mainrpt).pdf.
(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: http://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 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.
[[Page 68982]]
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.
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 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 soy-based beverage or tofu issued to
children who receive Food Package IV; and, any additional authorized
tofu and cheese issued to women who receive Food Packages V and VII
that exceeds the maximum substitution rate.
Steps Taken To Minimize Significant Economic Impact on Small Entities,
and Significant Alternatives Considered
FNS has considered significant alternatives in developing this
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 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
[[Page 68983]]
No. 10.557. For reasons set forth in the final rule in 7 CFR part 3015,
Subpart V and related Notice (48 FR 29114, June 24, 1983), this Program
is included in the scope of Executive Order 12372, which requires
intergovernmental consultation with State and local officials.
Federalism Summary Impact Statement
Executive Order 13132 requires Federal agencies to consider the
impact of their regulatory actions on State and local governments.
Where such actions have federalism implications, agencies are directed
to provide a statement for inclusion in the preamble to the regulations
describing the agency's considerations in terms of the three categories
called for under section (6)(b)(2)(B) of Executive Order 13132.
Prior Consultation With WIC State and Local Agency Officials
Over the years 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 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 (1977-present) of the National
Advisory Council on Maternal, Infant and Fetal Nutrition that includes
WIC staff as members of the Council; the Council develops
recommendations for FNS on how to improve operations of the WIC and
Commodity Supplemental Food Programs, including aspects related to the
authorized foods and food packages; and
Consulting and collaborating with NWA on a wide variety of
WIC issues, including those related to the WIC food packages (1983-
present). NWA is a non-profit 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 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,
[[Page 68984]]
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.
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.
E-Government Act Compliance
The Food and Nutrition Service is committed to complying with the
E-Government Act to promote the use of the Internet and other
information technologies to provide increased opportunities for citizen
access to Government information and services, and for other purposes.
List of Subjects in 7 CFR Part 246
Administrative practice and procedure, Civil rights, Food
assistance programs, Grant programs--health, Grant programs--social
programs, Indians, Infants and children, Maternal and child health,
Nutrition, Penalties, Reporting and recordkeeping requirements, Women.
0
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
0
1. The authority citation for part 246 continues to read as follows:
Authority: 42 U.S.C. 1786.
0
2. In Sec. 246.2:
0
a. Add new definitions of ``Cash-value voucher'' and ``Farmer'' in
alphabetical order;
0
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
cash-value vouchers'';
0
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 cash-value vouchers'';
0
d. Revise the definition of ``Participant violation'';
0
e. Revise the definition of ``Participation''; and
0
f. Amend the definition of ``WIC-eligible 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:
Sec. 246.2 Definitions.
* * * * *
Cash-value voucher means a fixed-dollar amount check, voucher,
electronic benefit transfer (EBT) card or other document which is used
by a participant to obtain authorized fruits and vegetables.
* * * * *
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.* * *
0
3. In Sec. 246.4:
0
a. Revise paragraph (a)(11)(iii).
0
b. Amend paragraph (a)(14)(iii) by revising the heading and the first
sentence;
0
c. Revise paragraph (a)(14)(vi);
0
d. Revise paragraph (a)(14)(xi);
0
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'';
[[Page 68985]]
0
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
0
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:
Sec. 246.4 State plan.
(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 Sec. 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 Sec.
246.12(q);
* * * * *
(xi) Vendor and farmer training. The procedures the State agency
will use to train vendors in accordance with Sec. 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.
* * * * *
0
4. In Sec. 246.7:
0
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
0
b. Revise paragraphs (f)(2)(iv), (h)(3)(i), (j)(3) and (j)(6).
The revisions read as follows:
Sec. 246.7 Certification of participants.
* * * * *
(f) * * *
(2) * * *
(iv) Each local agency using a retail purchase system shall issue a
food instrument(s) and if applicable cash-value 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 Sec. 246.12(r)(4).
* * * * *
(h) * * *
(3) * * *
(i) A State agency may allow local agencies to disqualify a
participant for failure to obtain food instruments, cash-value 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 cash-value 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.
* * * * *
0
5. Revise Sec. 246.10 to read as follows:
Sec. 246.10 Supplemental foods.
(a) General. This section prescribes the requirements for providing
supplemental foods to participants. The State agency must ensure that
local agencies comply with this section.
(b) State agency responsibilities. (1) State agencies may:
(i) Establish criteria in addition to the minimum Federal
requirements in Table 4 of paragraph (e)(12) of this section, 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
[[Page 68986]]
on an in-patient basis. In addition, consistent with Sec.
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 Sec.
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
Sec. 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 receive Food Packages V and VII that exceeds the maximum
substitution rate; and
(ix) Any contract brand infant formula that does not meet the
requirements in Table 4 of paragraph (e)(12) of this section.
(2) Supplemental foods not requiring medical documentation. (i)
State agencies may authorize local agencies to issue a non-contract
brand infant formula that meets the requirements in Table 4 of
paragraph (e)(12) of this section without medical documentation in
order to meet religious eating patterns; and
(ii) The State agency has the discretion to require medical
documentation for any contract brand infant formula and may decide that
some contract brand infant formula may not be issued under any
circumstances.
(3) Medical Determination. For purposes of this program, medical
documentation means that a health care professional licensed to write
medical prescriptions under State law has:
(i) Made a medical determination that the participant has a
qualifying condition as described in paragraphs (e)(3) through (e)(7)
of this section that dictates the use of the supplemental foods, as
described in paragraph (d)(1) of this section; and
(ii) Provided the written documentation that meets the technical
requirements described in paragraphs (d)(4)(ii) and (d)(4)(iii) of this
section.
(4) Technical Requirements--(i) Location. All medical documentation
must be kept on file (electronic or hard copy) at the local clinic. The
medical documentation kept on file must include the initial telephone
documentation, when received as described in paragraph (d)(4)(iii)(B)
of this section.
(ii) Content. All medical documentation must include the following:
(A) The name of the authorized WIC formula (infant formula, exempt
infant formula, WIC-eligible medical food) prescribed, including amount
needed per day;
(B) The authorized supplemental food(s) appropriate for the
qualifying condition(s) and their prescribed amounts;
(C) Length of time the prescribed WIC formula and/or supplemental
food is required by the participant;
(D) The qualifying condition(s) for issuance of the authorized
supplemental food(s) requiring medical documentation, as described in
paragraphs (e)(3) through (e)(7) of this section; and
(E) Signature, date and contact information (or name, date and
contact information), if the initial medical documentation was received
by telephone and the signed document is forthcoming, of the health care
professional licensed by the State to write prescriptions in accordance
with State laws.
(iii) Written confirmation--(A) General. Medical documentation must
be written and may be provided as an original written document, an
electronic document, by facsimile or by telephone to a competent
professional authority until written confirmation is received.
(B) Medical documentation provided by telephone. Medical
documentation may be provided by telephone to a competent professional
authority who must promptly document the information. The collection of
the required information by telephone for medical documentation
purposes may only be used until written confirmation is received from a
health care professional licensed to write medical prescriptions and
used only when absolutely necessary on an individual participant basis.
The local clinic must obtain written confirmation of the medical
documentation within a reasonable amount of time (i.e., one or two
week's time) after accepting the initial medical documentation by
telephone.
(5) Medical supervision requirements. Due to the nature of the
health conditions of participants who are issued supplemental foods
that require medical documentation, close medical supervision is
essential for each participant's dietary management. The responsibility
remains with the participant's health care provider for this medical
oversight and instruction. This responsibility cannot be assumed by
personnel at the WIC State or local 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
[[Page 68987]]
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 formula-feeding. Infant formula is not provided during the first
month after birth to fully breastfed infants to support the successful
establishment of breastfeeding.
(B) 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
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 formula-feeding, or partially
breastfeeding.
(iii) Infant formula requirements. The requirements for issuance of
infant formula in Food Package I, specified in paragraphs (e)(1)(iii)
and (e)(1)(iv) of this section, also apply to the issuance of infant
formula in Food Package II.
(iv) Authorized categories of supplemental foods. Infant formula,
infant fruits and vegetables, infant meat, and infant cereal are the
categories of supplemental foods authorized in this food package.
(3) Food Package III--Participants with qualifying conditions--(i)
Participant category served and qualifying conditions. This food
package is reserved for issuance to women, infants and child
participants who have a documented qualifying condition that requires
the use of a WIC formula (infant formula, exempt infant formula or WIC-
eligible medical food) because the use of conventional foods is
precluded, restricted, or inadequate to address their special
nutritional needs. Medical documentation must meet the requirements
described in paragraph (d) of this section. Participants who are
eligible to receive this food package must have one or more qualifying
conditions, as determined by a health care professional licensed to
write medical prescriptions under State law. The qualifying conditions
include but are not limited to premature birth, low birth weight,
failure to thrive, inborn errors of metabolism and metabolic disorders,
gastrointestinal disorders, malabsorption syndromes, immune system
disorders, severe food allergies that require an elemental formula, and
life threatening disorders, diseases and medical conditions that impair
ingestion, digestion, absorption or the utilization of nutrients that
could adversely affect the participant's nutrition status. This food
package may not be issued solely for the purpose of enhancing nutrient
intake or managing body weight.
(ii) Non-authorized issuance of Food Package III. This food package
is not authorized for:
(A) Infants whose only condition is:
(1) A diagnosed formula intolerance or food allergy to lactose,
sucrose, milk protein or soy protein that does not require the use of
an exempt infant formula; or
(2) A non-specific formula or food intolerance.
(B) Women and children who have a food intolerance to lactose or
milk protein that can be successfully managed with the use of one of
the other WIC food packages (i.e., Food Packages IV-VII); or
(C) Any participant solely for the purpose of enhancing nutrient
intake or managing body weight without an underlying qualifying
condition.
(iii) Restrictions on the issuance of WIC formulas in ready-to-feed
(RTF) forms. WIC State agencies must issue WIC formulas (infant
formula, exempt infant formula and WIC-eligible medical foods) in
concentrated liquid or powder physical forms unless the requirements
for issuing RTF are met as described in paragraph (e)(1)(iv) of this
section. In addition to those requirements, there are two additional
conditions which may be used to issue RTF in Food Package III:
(A) If a ready-to-feed form better accommodates the participant's
condition; or
(B) If it improves the participant's compliance in consuming the
prescribed WIC formula.
(iv) Unauthorized WIC costs. All apparatus or devices (e.g.,
enteral feeding tubes, bags and pumps) designed to administer WIC
formulas are not allowable WIC costs.
(v) Authorized categories of supplemental foods. The supplemental
foods authorized in this food package require medical documentation for
issuance and include infant formula (for children or women), exempt
infant formula, WIC-eligible medical foods, 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
[[Page 68988]]
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 soy-based beverage, tofu, or additional
cheese as a substitute for milk. Such determination can be made for
situations that include, but are not limited to, milk allergy, severe
lactose maldigestion, and vegan diets. Medical documentation must meet
the requirements described in paragraph (d) of this section.
(5) Food Package V--Pregnant and partially breastfeeding women--(i)
Participant category served. This food package is designed for issuance
to women participants with singleton pregnancies who do not have a
condition qualifying them to receive Food Package III. This food
package is also designed for issuance to breastfeeding women
participants, up to 1 year postpartum, who do not have a condition
qualifying them to receive Food Package III and whose partially
breastfed infants receive formula from the WIC program in amounts that
do not exceed the maximum allowances described in Table 1 of paragraph
(e)(9) of this section. Women participants breastfeeding more than one
infant, and women participants pregnant with more than one fetus, are
eligible to receive Food Package VII as described in paragraph (e)(7)
of this section.
(ii) Authorized categories of supplemental foods. Milk, breakfast
cereal, juice, fruits and vegetables, whole wheat bread or other whole
grains, eggs, legumes and peanut butter are the categories of
supplemental foods authorized in this food package. Cheese or calcium-
set tofu may be substituted for milk in amounts described in Table 2 of
paragraph (e)(10) of this section. Amounts of cheese or calcium-set
tofu exceeding the maximum substitution allowances may be allowed with
medical documentation of the qualifying condition, up to the maximum
allowance for fluid milk. A health care professional licensed by the
State to write prescriptions must make a medical determination and
provide medical documentation that a woman cannot drink milk and
requires additional cheese or calcium-set tofu. Such determination can
be made for situations that include, but are not limited to, milk
allergy or severe lactose maldigestion. Medical documentation must meet
the requirements described in paragraph (d) of this section.
(6) Food Package VI--Postpartum women--(i) Participant category
served. This food package is designed for issuance to women up to 6
months postpartum who are not breastfeeding their infants, and to
breastfeeding women up to 6 months postpartum whose participating
infant receives more than the maximum amount of formula allowed for
partially breastfed infants as described in Table 1 of paragraph (e)(9)
of this section.
(ii) Authorized categories of supplemental foods. Milk, breakfast
cereal, juice, fruits and vegetables, eggs, and legumes or peanut
butter are the categories of supplemental foods authorized in this food
package. Cheese or calcium-set tofu may be substituted for milk in
amounts described in Table 2 of paragraph (e)(10) of this section.
Amounts of cheese or calcium-set tofu exceeding the maximum
substitution allowances may be allowed with medical documentation of
the qualifying condition, up to the maximum allowance for fluid milk. A
health care professional licensed by the State to write prescriptions
must make a medical determination and provide medical documentation
that a woman cannot drink milk and requires additional cheese or
calcium-set tofu. Such determination can be made for situations that
include, but are not limited to, milk allergy or severe lactose
maldigestion. Medical documentation must meet the requirements
described in paragraph (d) of this section.
(7) Food Package VII--Fully breastfeeding--(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:
[[Page 68989]]
Table 1.--Maximum Monthly Allowances of Supplemental Foods for Infants in Food Packages I, II and III
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fully formula fed (FF) Partially breastfed (BF/FF) Fully breastfed (BF)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food packages I-
Food packages I- BF/FF & III BF/FF Food packages II-
FF & III-FF A: 0 Food packages II- A: 0 to 1 month BF/FF & III BF/ Food package I-BF 0 Food package II-BF 6
Foods \1\ through 3 months FF & III-FF 6 \2\ B: 1 through FF 6 through 11 through 5 months through 11 months
B: 4 through 5 through 11 months 3 months \2\ C: 4 months
months through 5 months
--------------------------------------------------------------------------------------------------------------------------------------------------------
WIC Formula 4 5 6 7........... A: 806 fl oz 624 fl oz A: 104 fl oz 312 fl oz
reconstituted reconstituted reconstituted reconstituted
liquid liquid powder \3\ liquid
concentrate or concentrate or B: 364 fl oz concentrate or
832 fl oz RTF or 640 fl oz RTF or reconstituted 320 fl oz RTF or
870 fl oz 696 fl oz liquid 384 fl oz
reconstituted reconstituted concentrate or reconstituted
powder. powder. 384 fl oz RTF or powder.
B: 884 fl oz 435 fl oz
reconstituted reconstituted
liquid powder.
concentrate or C: 442 fl oz
896 fl oz RTF or reconstituted
960 fl oz liquid
reconstituted concentrate or
powder. 448 fl oz RTF or
522 fl oz
reconstituted
powder.
Infant cereal \8\............. ................. 24 oz............ ................. 24 oz............ ..................... 24 oz.
Infant food fruits and ................. 128 oz........... ................. 128 oz........... ..................... 256 oz.
vegetables 8 9 10.
Infant food--meat 8 10........ ................. ................. ................. ................. ..................... 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
-------------------------------------------------------------------------------
Food package V:
Pregnant and Food package VI: Food package VII:
Foods \1\ Food package IV 1 partially Postpartum (up to Fully
through 4 years breastfeeding (up 6 months breastfeeding (up
to 1 year postpartum) \3\ to 1 year post-
postpartum) \2\ partum) \4\ \5\
----------------------------------------------------------------------------------------------------------------
Juice, single strength \6\...... 128 fl oz......... 144 fl oz......... 96 fl oz.......... 144 fl oz.
Milk, fluid..................... 16 qt 7 8 9 10.... 22 qt. 7 8 11 12.. 16 qt. 7 8 11 12.. 24 qt. 7 8 11 12
Breakfast cereal \13\........... 36 oz............. 36 oz............. 36 oz............. 36 oz.
Cheese.......................... N/A............... N/A............... N/A............... 1 lb.
Eggs............................ 1 dozen........... 1 dozen........... 1 dozen........... 2 dozen.
Fruits and vegetables 14 15..... $6.00 in cash $8.00 in cash- $8.00 in cash- $10.00 in cash-
value vouchers. value vouchers. value vouchers. value vouchers.
Whole wheat bread or other whole 2 lb.............. 1 lb.............. N/A............... 1 lb.
grains \16\.
Fish (canned)................... N/A............... N/A............... N/A............... 30 oz.
[[Page 68990]]
Legumes, dry \17\............... 1 lb.............. 1 lb.............. 1 lb.............. 1 lb.
And/or peanut butter............ Or 18 oz.......... And 18 oz......... Or 18 oz.......... And 18 oz.
----------------------------------------------------------------------------------------------------------------
Table 2 Footnotes: N/A = the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the
supplemental foods.
\2\ Food Package V is issued to two categories of WIC participants: Women participants with singleton
pregnancies and breastfeeding women whose partially breastfed infants receive formula from the WIC Program in
amounts that do not exceed the maximum formula allowances for Food Packages I-BF/FF-A, I-BF/FF-B, 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, 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\ 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 Sec. 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
-------------------------------------------------------------------------------
Pregnant and
Foods\1\ partially Postpartum (up to Fully
1 through 4 years breastfeeding (up 6 months breastfeeding, (up
to 1 year postpartum) \3\ to 1 year post-
postpartum) \2\ partum) \4\ \5\
----------------------------------------------------------------------------------------------------------------
Juice, single strength \6\...... 128 fl oz......... 144 fl oz......... 96 fl oz.......... 144 fl oz.
WIC Formula \7\ \8\............. 455 fl oz liquid 455 fl oz liquid 455 fl oz liquid 455 fl oz. liquid
concentrate. concentrate. concentrate. concentrate.
Milk............................ 16 qt \9\ \10\ 22 qt \9\ \10\ 16 qt \9\ \10\ 24 qt. \9\ \10\
\11\ \12\. \13\ \14\. \13\ \14\. \13\ \14\
Breakfast cereal \15\ \16\...... 36 oz............. 36 oz............. 36 oz............. 36 oz.
Cheese.......................... N/A............... N/A............... N/A............... 1 lb.
Eggs............................ 1 dozen........... 1 dozen........... 1 dozen........... 2 dozen.
[[Page 68991]]
Fruits and vegetables \17 18\... $6.00 in cash $8.00 in cash $8.00 in cash $10.00 in cash
value vouchers. value vouchers. value vouchers. value vouchers.
Whole wheat bread \19\.......... 2 lb.............. 1 lb.............. N/A............... 1 lb.
Fish (canned)................... N/A............... N/A............... N/A............... 30 oz.
Legumes, dry \20\............... 1 lb.............. 1 lb.............. 1 lb.............. 1 lb.
and/or Peanut butter............ Or 18 oz.......... And 18 oz......... Or 18 oz.......... And 18 oz.
----------------------------------------------------------------------------------------------------------------
Table 3 Footnotes: N/A=the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the
supplemental foods.
\2\ 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 Sec. 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
------------------------------------------------------------------------
Categories/foods Minimum requirements and specifications
------------------------------------------------------------------------
WIC formula:
Infant formula........... All authorized infant formulas must (1)
meet the definition for an infant
formula in section 201(z) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
321(z)) and meet the requirements for an
infant formula under section 412 of the
Federal Food, Drug and Cosmetic Act, as
amended (21 U.S.C. 350a) and the
regulations at 21 CFR parts 106 and 107;
[[Page 68992]]
(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.
Exempt infant formula.... All authorized exempt infant formula must
(1) meet the definition and requirements
for an exempt infant formula under
section 412(h) of the Federal Food,
Drug, and Cosmetic Act as amended (21
U.S.C. 350a(h)) and the regulations at
21 CFR Parts 106 and 107; and
2) Be designed for enteral digestion via
an oral or tube feeding.
WIC-eligible medical Certain enteral products that are
foods.\1\ 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)).
Milk and milk alternatives:
Cow's milk............... Must conform to FDA standard of identity
for whole, reduced fat, low-fat, or non-
fat milks (21 CFR 131.110). Must be
pasteurized and contain at least 400 IU
of vitamin D per quart (100 IU per cup)
and 2000 IU of vitamin A per quart (500
IU per cup).
May be flavored or unflavored. May be
fluid, shelf-stable, evaporated (21 CFR
131.130), or dried (i.e., powder) (21
CFR 131.147).\2\
Cultured Milks. Must conform to FDA
standard of identity for cultured milk
(21 CFR 131.112--cultured buttermilk,
kefir cultured milk, acidophilus
cultured milk).
Goat milk................ Must conform to FDA standard of identity
for whole, reduced fat, low-fat, or non-
fat milks (21 CFR 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\
Cheese................... 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\
Tofu..................... Calcium-set tofu prepared with only
calcium salts (e.g., calcium sulfate).
May not contain added fats, sugars,
oils, or sodium.
Soy-based beverage....... Must be fortified to meet the following
nutrient levels: 276 mg calcium per cup,
8 g protein per cup, 500 IU vitamin A
per cup, 100 IU vitamin D per cup, 24 mg
magnesium per cup, 222 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.
Juice........................ Must be pasteurized 100% unsweetened
fruit juice. Must conform to FDA
standard of identity (21 CFR part 146)
or vegetable juice must conform to FDA
standard of identity (21 CFR part 156)
and contain at least 30 mg of vitamin C
per 100 mL of juice. With the exception
of 100 percent citrus juices, State
agencies must verify the vitamin C
content of all State-approved juices.
Juices that are fortified with other
nutrients may be allowed at the State
agency's option. Juice may be fresh,
from concentrate, frozen, canned, or
shelf-stable.
Vegetable juice may be regular or lower
in sodium.\3\
Eggs......................... Fresh shell domestic hens' eggs or dried
eggs mix (must conform to FDA standard
of identity in 21 CFR 160.105) or
pasteurized liquid whole eggs (must
conform to FDA standard of identity in
21 CFR 160.115).
Hard boiled eggs, where readily available
for purchase in small quantities, may be
provided for homeless participants.
Breakfast cereal............. Breakfast cereals as defined by FDA in 21
CFR 170.3(n)(4) for ready-to-eat and
instant and regular hot cereals.
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.
Fruits and Vegetables (fresh Any variety of fresh whole or cut fruit
and processed). 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\
[[Page 68993]]
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 7\
Any type of dried fruits or dried
vegetable without added sugars, fats,
oils, or salt (i.e., sodium).\5\
Whole wheat bread/Whole grain Bread
bread/Other whole Whole wheat bread must conform to FDA
unprocessed grains. 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 fish \6\.............. Canned only:
Light tuna (must conform to FDA standard
of identity (21 CFR 161.190));
Salmon (must conform to FDA standard of
identity (21 CFR 161.170));
Sardines;
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\
Mature legumes (dry beans and Any type of mature dry beans, peas, or
peas). lentils in dry-packaged or canned \6\
forms. Examples include but are not
limited to black beans (``turtle
beans''), blackeye peas (cowpeas of the
blackeye variety, ``cow beans''),
garbanzo beans (chickpeas), great
northern beans, kidney beans, lima beans
(``butter beans''), navy beans, pinto
beans, soybeans, split peas, and
lentils. All categories exclude soups.
May not contain added sugars, fats, oils
or meat as purchased. Canned legumes may
be regular or lower in sodium content.\3
8\
Baked beans may be provided for
participants with limited cooking
facilities.\8\
Peanut butter................ Peanut butter and reduced fat peanut
butter (must conform to FDA Standard of
Identity (21 CFR 164.150)); creamy or
chunky, regular or reduced fat, salted
or unsalted \3\ forms are allowed.
Infant Foods:
Infant cereal............ Infant cereal must contain a minimum of
45 mg of iron per 100 g of dry
cereal.\9\
Infant fruits............ Any variety of single ingredient
commercial infant food fruit without
added sugars, starches, or salt (i.e.,
sodium). Texture may range from strained
through diced.\10\
Infant vegetables........ Any variety of single ingredient
commercial infant food vegetables
without added sugars, starches, or salt
(i.e., sodium). Texture may range from
strained through diced.\11\
Infant meat.............. Any variety of 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 lactose-free, acidified, and UHT pasteurized milks. Other milks
are permitted at the State agency's discretion provided that the State
agency determines that the milk meets the minimum requirements for
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 low-sodium food'' must appear on the same panel as the
Nutrition Facts panel.); and
[[Page 68994]]
Reduced or less sodium--at least 25 percent less sodium per serving than
reference food.
\4\ Food and Drug Administration (FDA), Health Claim Notification for
Whole Grain Foods with Moderate Fat Content at http://www.cfsan.fda.gov/~dms/flgrain2.html
\ 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 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) 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:
[[Page 68995]]
(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.
0
6. In Sec. 246.12:
0
a. Revise the second sentence of paragraph (a)(1).
0
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'';
0
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 cash-value vouchers'';
0
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'';
0
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);
0
f. Amend paragraph (t) by removing the word ``vendor'' and adding in
its place the words ``vendor, farmer''; and
0
g. Add a new paragraph (v).
The addition and revisions read as follows:
Sec. 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 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 cash-value 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 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 cash-value 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 cash-value
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
[[Page 68996]]
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 cash-value
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 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 Sec. 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 cash-value 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 cash-
value vouchers throughout the State agency's jurisdiction; monthly
physical inventory of food instruments or cash-value 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 cash-value 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 Sec. 246.13. The State agency will be
subject to claims as outlined in Sec. 246.23(a)(4) for redeemed food
instruments or cash-value vouchers that do not meet the conditions
established in paragraph (q) of this section.
(r) Issuance of food instruments, cash-value vouchers and
authorized 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 cash-value 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 Sec. 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
[[Page 68997]]
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
cash-value 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 cash-value 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 cash-value 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;
(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 cash-value 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 Sec. 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 cash-value 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 Sec. 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.
0
7. In Sec. 246.16, add a new paragraph (j) to read as follows:
Sec. 246.16 Distribution of funds.
* * * * *
(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 inflation-
adjusted 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.
0
8. In Sec. 246.18:
0
a. Amend paragraph (a)(1)(iii)(G) by removing the words ``food
instrument''
[[Page 68998]]
and adding in their place the words ``food instrument or cash-value
voucher'';
0
b. Add a new paragraph (a)(4);
0
c. Revise the introductory text of paragraph (b);
0
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'';
0
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
0
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:
Sec. 246.18 Administrative review of State agency actions.
(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:
* * * * *
0
9. In Sec. 246.23, revise paragraph (a)(4) to read as follows:
Sec. 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 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 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 long-term
breastfeeding; provide WIC participants with a wider variety of
food; provide WIC State agencies with greater flexibility in
prescribing food packages to accommodate participants with cultural
food preferences; and, serve 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
[[Page 68999]]
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
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 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.
---------------------------------------------------------------------------
\1\ 7 CFR 246.7(e).
---------------------------------------------------------------------------
WIC addresses the supplemental nutritional needs of at-risk
groups through the distribution of age- and condition-specific food
packages, and a program of nutrition education that includes
counseling, 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 sub-populations:
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 low-income
women, infants, and children. Current WIC food packages reflect that
early research. Today's packages include some combination of: iron-
fortified infant formulas, iron-fortified cereals, vitamin C rich
juice, vitamin A and D fortified milk, eggs, cheese, dried beans or
peas, peanut butter, tuna, and carrots. Other factors that
contributed to the selection of these foods are their nutrient
density, modest cost, wide availability, and broad acceptance by the
WIC-eligible population.
---------------------------------------------------------------------------
\2\ See 42 U.S.C. 1786(a).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ 7 CFR 246.11.
---------------------------------------------------------------------------
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 WIC-approved
foods provides select, nutrient-rich foods; allowed substitutions
provide only limited room for participant-specific food package
tailoring.
---------------------------------------------------------------------------
\4\ 42 U.S.C. 1786(b)(14).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 69000]]
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 WIC-eligible 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.
---------------------------------------------------------------------------
\6\ National Academies, Institute of Medicine (IOM). WIC Food
Packages: Time for a Change, Washington, DC: The National Academies
Press, 2005. pp. 31, 64.
\7\ U.S. Department of Agriculture, Food and Nutrition Web site,
July 2005. http://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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\10\ See IOM, p. 63; see also ``High Costs of Poor Eating
Patterns in the United States,'' Elizabeth Fraz[atilde]o, in
America's Eating Habits: Changes and Consequences, Elizabeth
Fraz[atilde]o, ed., Economic Research Service, U.S. Department of
Agriculture, Washington, DC, 1999.
---------------------------------------------------------------------------
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 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,
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
[[Page 69001]]
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.
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.
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.
[[Page 69002]]
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 fat-reduced 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\
---------------------------------------------------------------------------
\12\ See 21 CFR Part 136, Section 136.180, and FDA's Health
Claim Notification for Whole Grain Foods with Moderate Fat Content
at http://www.cfsan.fda.gov/dms/flgrain2.html.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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,
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.
---------------------------------------------------------------------------
\14\ See 21 CFR Part 136, Section 136.180, and FDA's Health
Claim Notification for Whole Grain Foods with Moderate Fat Content
at http://www.cfsan.fda.gov/dms/flgrain2.html.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\15\ Baked in-store breads generally have no label.
---------------------------------------------------------------------------
Proposed rule: Reduce maximum egg prescription.
Reduce the maximum egg prescription from two and one-half dozen
per month \16\ to one dozen.
---------------------------------------------------------------------------
\16\ Some states currently allow just two dozen as the monthly
maximum.
---------------------------------------------------------------------------
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.
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.
---------------------------------------------------------------------------
\17\ Tofu prepared with only calcium salts.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\18\ See 21 CFR Part 136, Section 136.180, and FDA's Health
Claim Notification for Whole Grain Foods with Moderate Fat Content
at http://www.cfsan.fda.gov/dms/flgrain2.html.
---------------------------------------------------------------------------
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
[[Page 69003]]
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.
---------------------------------------------------------------------------
\19\ See 21 CFR Part 136, Section 136.180, and FDA's Health
Claim Notification for Whole Grain Foods with Moderate Fat Content
at http://www.cfsan.fda.gov/dms/flgrain2.html.
---------------------------------------------------------------------------
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.
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
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.
---------------------------------------------------------------------------
\20\ See 21 CFR Part 136, Section 136.180, and FDA's Health
Claim Notification for Whole Grain Foods with Moderate Fat Content
at http://www.cfsan.fda.gov/dms/flgrain2.html.
---------------------------------------------------------------------------
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
[[Page 69004]]
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\
---------------------------------------------------------------------------
\21\ See 21 CFR Part 136, Section 136.180, and FDA's Health
Claim Notification for Whole Grain Foods with Moderate Fat Content
at http://www.cfsan.fda.gov/~dms/flgrain2.html.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\22\ See 21 CFR Part 136, Section 136.180, and FDA's Health
Claim Notification for Whole Grain Foods with Moderate Fat Content
at http://www.cfsan.fda.gov/~dms/flgrain2.html.
---------------------------------------------------------------------------
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 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. 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-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.
[[Page 69005]]
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.
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: State/local
USDA/Federal gov't agencies Vendors/industry WIC participants
----------------------------------------------------------------------------------------------------------------
Current rule:
1. Food Package I serves Reduces cost of Changes to May increase the Provides a food
infants from birth through infant food current rules sale of infant package that
three months. Formula is the packages. Interim will require the formula at the conforms more
only food prescribed under packages for four implementation expense of juice closely to the
Package I. and five month of new state and and infant diet recommended
old infants local cereal. by health
(which reduce administrative professionals
calories procedures. for four and
slightly) are five month old
less expensive infants.
than current Food
Package II.
2. Infants from four through
eleven months are eligible for
juice and infant cereal, in
addition to formula, under
Package II. The maximum
formula prescription in
packages I and II are the
same.
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.
[[Page 69006]]
-$
Current rule:
Under Food Package I, an infant If breastfeeding State and local Negligible effect Although some
can receive up to the maximum increases enough agencies must on the sale of participants may
infant formula for the to keep an infant develop new infant formula receive less
package. Since the rule does classified as guidelines to for newborn food or formula
not separate partially and partially implement and infants. But, under the
fully formula fed infants, a breastfed who communicate this the rule interim
single package maximum applies would have been policy. provides an packages, in
to all partially and fully classified as incentive to general, WIC
formula-fed infants from birth fully formula fed breastfeed, infants and
through three months. Food otherwise, then which may mothers will
Package V is provided to formula costs are ultimately benefit from the
pregnant women and to all new reduced and there reduce formula enhanced
mothers, up to one year is no change in sales beyond the packages and
postpartum, if they breastfeed the mother's infants' first package
at least once per day. Food status. For month. Moving assignment
Package VII is provided to partially mothers from the method.
fully breastfeeding mothers. breastfed infants fully formula Breastfeeding
Interim rule: under one month fed package to education and
Infants and mothers will be of age, the low the partially or limited formula
assigned food packages based formula limit exclusively provided to new
on the mother's reported provided during breastfeeding mothers by WIC
breastfeeding practice. The that first month, packages, may staff may
corresponding amount of paired with the slightly successfully
formula prescribed will net effect of increase food increase
distinguish infants less than mothers and sales to breastfeeding
4 months of age as partially infants switching breastfeeding rates. This is
breastfed or fully formula- from fully- mothers. consistent with
fed. The rule would provide a formula feeding the
full formula-feeding package or fully recommendations
to some infants currently breastfeeding to of nutrition
considered partially partially experts.
breastfed; it would move some breastfeeding However, it is
mothers from Package V to during the first uncertain
Package VI. Partially month may reduce whether this
breastfed infants under one costs during the will have a
month of age would be allowed infant's first significant
to receive limited infant month. However, a impact on the
formula; this would move some sustained number of WIC
mothers from Package VI or VII increase in women who
to Package V. breastfeeding breastfeed.
-$ 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.
Current rule:
[[Page 69007]]
The current infant food If the interim State and local Negligible effect Although the WIC
packages do not distinguish rule has no agencies must in the absence food benefit
between fully and partially direct effect on conform to a new of changes in received by
formula-fed infants. Infants the initiation definition of breastfeeding women who do not
receive infant formula based and duration of breastfeeding behavior. fully breastfeed
on an assessment of their breastfeeding, for WIC food Increased may be reduced,
supplemental nutritional the cost of package breastfeeding in general, WIC
needs, subject to a single providing food purposes. Will would reduce infants and
package maximum. Food Package packages to women also encourage formula sales mothers will
V is provided to pregnant will drop; the changes in the but might benefit from the
women and to all new mothers, cost of providing approach to modestly enhanced
up to one year postpartum, if infant formula nutrition increase the packages and
they breastfeed at least once will remain education; sale of infant package
per day and their infant unchanged. If places greater food fruits, assignment
receives some formula. breastfeeding emphasis on vegetables and method. The
increases enough breastfeeding meat to WIC's interim packages
to keep an infant promotion. fully breastfed encourage
classified as Implementing new population. breastfeeding
partially procedures will consistent with
breastfed who initially the best advice
would have been increase of nutrition
classified as administrative science.
fully formula fed burden. However,
otherwise, then breastfeeding is
formula costs are a behavior with
reduced and there many complex
is no change in determinants,
the mother's and it is
status. Both unlikely that
result in cost the food package
reductions. changes alone
will alter
breastfeeding
practices.
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 These women are State agencies Negligible effect Encourages more
breastfeeding in WIC already counted will be provided because it intensive
regulations allows women who as participants NSA funds for a applies only to breastfeeding
breastfeed once a day to be when they receive very small the few women for WIC women
eligible for the WIC program food benefits as number of women who breastfeed after six months
and receive supplemental breastfeeding who are for longer than of
foods. women, so the net receiving WIC six months but participation.
effect of the benefits request the full
change in the (nutrition formula fed
definition of education/ amount of infant
participation is breastfeeding formula for
minimal. These support and their infant.
women will referrals to These mothers
continue to be health and once received
included in social supplemental
participation services), but foods but will
numbers and State not receiving no longer be
agencies will be supplemental eligible for
provided NSA foods. these foods.
funds. They will still
be visiting WIC
approved vendors
to obtain infant
formula.
Interim rule:
[[Page 69008]]
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 The net effect of Implementing new May increase Restructures the
eligible for Food Package II. these changes procedures, such sales of infant infant package
That food package includes increases the as setting state food and according to the
juice and infant cereal, as cost of Food policy on decrease sales recommendations
well as formula. Package II. allowed of juice and of current
varieties of formula if nutrition
infant food, participants science.
will increase were not already Increases
short-term using the benefits by
administrative quantities in adding fruits
burden. MIS the interim and vegetables,
systems will rule. Some but decreases
need to be vendors may need maximum
revised for new to stock allowance of
foods (infant additional infant formula
fruits and infant food and eliminates
vegetables), varieties that juice.
quantities, and meet the Encourages good
the new age specific infant feeding
range. Need to specifications practices and
train WIC staff, set by the the consumption
vendors and states. Vendors of fruits and
participants on will need to vegetables.
new foods. train personnel
to identify the
newly WIC-
eligible infant
foods.
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 cost of the Implementing new Increase in sales Provides added
the same amounts of formula, fully breastfed procedures, such of infant food iron and zinc to
juice, and infant cereal under package for as setting state meat is likely the diet of
Food Package II. infants age six rules on to be fully breastfed
months and older permissible negligible. The infants age six
is increased varieties of number of fully months and
significantly. infant food breastfed WIC older. Also
meat, will infants age six encourages
increase short- months and over breastfeeding by
term is small. increasing
administrative Vendors will benefits. Both
burden. Need to need to train are consistent
train WIC staff, personnel to with the
vendors and identify the recommendations
participants on newly WIC- of current
new foods. MIS eligible infant nutrition
systems will foods and science.
need to be distinguish them
revised. from similarly
packaged
ineligible
items.
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:
[[Page 69009]]
1. Low iron infant formula may These changes are The states will Sales of low iron The very few WIC
be prescribed with medical expected to have incur minimal formula and participants who
documentation. little effect on short-term certain infant have been
2. Infant cereal must be iron- the foods administrative cereal varieties receiving low
fortified; WIC regulations actually burden as they will be reduced iron formula
contain no other prescribed to WIC implement these slightly, if at from WIC will
specifications. infants. The minor rule all, by these either need to
infant cereal changes. Local rules. purchase the
rule simply WIC agencies product or work
formalizes what will need to with their
has been federal communicate the medical provider
policy since ``no low iron to change to an
1980. infant formula iron fortified
from WIC'' infant formula
concept to the authorized by
local medical WIC.
community and
some
participants.
MIS systems will
need to be
revised.
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 The rule is The rule is No impact. No direct impact.
dietary needs are prescribed intended to intended to Improved service
WIC-eligible medical foods reduce facilitate at the state and
under Food Package III. administrative program local level may
Infants with special dietary costs and management. It result, to the
needs are provided exempt facilitate may also allow benefit of WIC
infant formula under Food program improved service participants.
Packages I or II. management. to WIC
beneficiaries.
MIS systems will
need to be
revised.
Interim rule:
Serve infants with special
dietary needs who receive
exempt infant formulas under
Food Package III.
-$
Current rule:
Current practice allows some Clarifies who is The rule may Possible minimal Some current
women and children with eligible for Food reduce reduction in the participants
certain dietary restrictions, Package III and administrative sale of medical receiving
but without serious medical what foods may be burden by foods due to Package III may
conditions, to be prescribed distributed as eliminating eligibility be served under
medical foods under Food part of that Package III requirements. food packages
Package III. package. These eligibility more appropriate
clarifications issues. But, it to their needs.
are generally may require
aimed at state efforts to
tightening these educate local
criteria. Will, WIC officials,
if anything, WIC
reduce Package participants,
III costs by and health care
moving some professionals on
participants to the eligibility
food packages criteria.
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.
Interim rule:
Clarify language governing the
purpose and scope of Package
III eligibility.
-$
Current rule:
[[Page 69010]]
Package III recipients are This rule will Administrative May have a small For those Package
prescribed medical foods only; increase costs in burden of positive effect III recipients
they do not receive any of the those cases where implementing the on the sale of able to consume
standard food package foods. Food Package III new rule will be some secondary at least some
recipients are incurred in the WIC foods. Will non-Package III
able to consume short run. Local not affect sales WIC foods, this
the foods agencies will of infant rule will
contained in the need to formula. provide them
regular WIC food determine which with additional
packages to which WIC foods can be food.
they would purchased to
otherwise be each Food
eligible. But, Package III
the Package III recipient. MIS
population is systems will
small. The costs need to be
will be modest. revised.
Interim rule:
Make other WIC foods available
to Package III recipients.
+$
Current rule:
Food Packages IV through VII The net effect of The states will The rule may Reduces dairy
provide WIC beneficiaries with this provision need to result in component of WIC
24 to 28 quarts of milk per will be a establish new reduced milk and benefit. WIC
month. Cheese may be reduction in specifications cheese sales to participants who
substituted for milk at a rate overall cost, due and restrictions WIC are unable to
of one pound per three quarts; to the reduction for the new milk participants. It drink milk may
cheese may replace a total of in quantities substitutes. may lead to benefit most by
12 quarts of milk. allowed and They will also increased sales the addition of
reduced incur of tofu and soy these new
substitution administrative beverage. substitutes.
amounts. burden in Vendors may need Others with
implementing to stock new individual or
changes to items that match cultural
reflect reduced the specific preferences will
milk product also benefit by
prescription requirements set the added
maximums and by the states. choices. All WIC
substitution Rule proposes participants
limits. Local nutritional will benefit
agencies will standards for from a package
need to educate soy milk that lower in
WIC vendors and are currently saturated and
participants on not met by many total fat,
new food items. products on the consistent with
MIS systems will market. Because the
need to be these standards recommendations
revised. will also apply of current
to the school nutrition
meals programs, science.
vendors are
likely to change
fortification so
that the variety
of available soy
beverages that
can be
authorized
improves over
time.
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:
[[Page 69011]]
Juice may be prescribed under The fixed dollar States will need Juice sales to Expands WIC
Food Packages IV through VII values of the to authorize and WIC participants benefits by
at maximum levels that range fruit and develop a may decline. adding fruits
from 192 to 336 fl. oz. per vegetable structure to Sales of fruits and vegetables,
month. vouchers in the distribute and and vegetables while reducing
interim rule are redeem fruit and may increase. juice amounts.
greater than the vegetable Costs will be The addition of
offsetting vouchers, which incurred by fruits and
savings that will will be a new vendors as they vegetables to
be realized component of the learn to the WIC food
through reduced programs. This accommodate the packages
juice amounts. administrative new WIC responds to the
burden will be vouchers. Some recommendations
on-going but WIC authorized of nutrition
part of the vendors may need science. And the
current banking to add fruits flexibility of a
and MIS systems. and vegetables voucher will
State and local to their stocks provide access
agencies will in fresh, to a variety of
incur frozen, or fruits and
administrative canned form. vegetables, in
burden in Emphasis on some form, year
developing fresh fruits and round, in all
educational vegetables may markets.
messages for WIC encourage states
participants to authorize and
concerning the participants to
selection of shop at farmers
nutritious markets more
fruits and often. (See
vegetables. Need Market Analysis
to train WIC discussion in
staff, vendors Section G).
and participants
on new food
amounts. MIS
systems will
need to be
revised.
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 Reducing the State and local Sales of eggs to This change
Packages IV through VII. maximum egg administrative WIC participants reduces food
States may set their monthly prescription will burden will be will decline. energy,
maximums at either 2 or 2\1/2\ produce a modest incurred in the Market effects cholesterol, and
dozen per month. reduction in food short term as will be minimal. fat content of
package costs. new procedures the WIC food
That reduction is are put in packages. The
used to help place. Local changes are
offset costs of agencies will consistent with
new foods and need to educate the advice of
substitution WIC vendors and current
options. participants on nutrition
new food science. The
amounts. MIS reduction in
systems will food energy also
need to be makes room for
revised. the introduction
of new foods
that address
priority
nutrient needs.
Interim rule:
1. Reduce maximum egg
prescription in all food
packages for women and
children.
-$
Current rule:
[[Page 69012]]
There are no restrictions on Prescribing only State and local Market effects This proposal
the fat content allowed in fat reduced milk administrative will be minimal. reduces total
milk. to women and burden will be Vendors will fat and
children age two incurred in the need to train saturated fat
and older will short term as personnel to content of the
have a negligible new procedures allow the type WIC food
effect on cost. are put in of milk packages. The
place. Local specified on the change is
agencies will food consistent with
need to educate instruments. the advice of
WIC vendors and current
participants on nutrition
new food science.
amounts. MIS
systems will
need to be
revised.
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 The addition of State and local Manufacturers may WIC participants
current food packages for whole grain bread agencies will respond by will benefit
women and children in the form to Packages IV, incur reformulating from food
of breakfast cereal. Current V, and VII administrative popular WIC- packaged
regulations do not specify a increases the burden to approved cereals enhanced with
minimum whole grain content cost of those implement the in whole grain whole grain
for that product. packages. The new rules. form. Smaller cereals and food
requirement for States will vendors may need products. The
50 percent of incur to modify stocks addition of
available cereals administrative to include whole whole grains to
for children and burden in grain bread the WIC packages
women to be establishing varieties and at is consistent
classified as specifications least one whole with 2005
whole grain will and restrictions grain cereal. Dietary
have a minor for the new All vendors will Guidelines for
effect on cost. foods and need to train Americans that
substitution personnel to encourage
options and readily identify increased
local clinics WIC-eligible consumption of
will incur breads and these foods.
additional grains.
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.
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:
[[Page 69013]]
Dry beans are included in Food The rate of The option in the Market effects By adding variety
Packages IV, V, and VII. substitution interim rule will be minimal. and convenience,
Canned beans may be between canned will prompt But, as with the the canned bean
prescribed, instead of dry, to and dry beans in states to set addition of any option should
WIC participants who lack the interim rule specifications WIC substitution increase the
cooking facilities. will increase and option, small appeal of that
costs. However, restrictions. vendors may need food. It may
the cost of beans Other short-term to add new items also encourage
in the food administrative to their stocks, greater
packages is burden will be and all vendors consumption,
relatively small incurred as the will need to replacing less
and this change new rule is put train personnel healthy foods in
will have a in place. Local to identify the the diets of WIC
relatively modest agencies will newly-eligible participants.
effect on overall need to educate WIC foods.
program cost. WIC vendors and
participants on
new food
amounts. MIS
systems will
need to be
revised.
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 The costs of food Neither of these Minimal market The addition of
included in Food Package VI. packages V and VI changes impact. beans and peanut
Package V currently provides a are increased. introduces foods butter increases
pound of dry beans; those can not already benefits to WIC
be replaced with 18oz of included in participants.
peanut butter. other WIC These changes
packages. Local supplement the
agencies will diets of
need to educate breastfeeding
WIC vendors and and postpartum
participants on women with
new food several of the
amounts. MIS priority
systems will nutrients
need to be identified by
revised. the IOM.
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 Costs will States and local Minimal market These changes add
to exclusively breastfeeding increase agencies will impact. But, may new choices that
women in Food Package VII. slightly. While incur force small may encourage
White, light, or dark tuna, the new administrative vendors to stock consumption. The
packed in water or oil, is substitution burden in additional types rule also
allowed. option may implementation. of canned fish responds to
increase the cost State agencies and will require medical advice
of individual will adopt all vendors to that
prescriptions, specifications train personnel breastfeeding
the number of WIC and restrictions to identify women avoid fish
participants for the new newly-eligible species that are
eligible for Food substitution WIC foods. high in mercury.
Package VII is option. Local
very small. agencies will
need to educate
WIC vendors and
participants on
new food
amounts. MIS
systems will
need to be
revised.
Interim rule:
[[Page 69014]]
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 This simply States are given If States adopt WIC participants
restrictions on some foods by clarifies what is formal approval restrictions on may need to
brand or variety in order to already accepted for current the brands or switch brands or
limit cost or ensure statewide policy. The practice. States varieties of varieties of
product availability. The policy is an should incur foods newly foods that they
practice is accepted but not effective way to little or no added to the WIC currently
formally authorized by control costs. administrative food packages, consume to
regulation. Since the rule burden in then brands and
represents no implementation. participants who varieties
change from already purchase consistent with
current practice, those foods may those added to
it results in no switch their the WIC
economic impact. selection of packages.
brands or
varieties to the
WIC-approved
choices. A
measurable shift
in consumption
by brand or
variety may
result.
Interim rule:
Clarifies the right of States
to restrict WIC foods by
variety or brand.
(minimal economic impact)
Current rule:
States are permitted to Assures more The rule reduces Minimal effect on Assures more
prescribe foods to WIC consistent WIC the level of vendors and consistent WIC
participants in quantities benefits are work currently producers. benefits are
that are less than the package delivered across undertaken by delivered across
maximums when nutritionally States. State officials. States. IOM has
warranted. States may also Administrative based food
standardize these reductions burden will prescription
and apply the reduced amounts decrease to the quantities on
consistently to like groups of extent that current
WIC participants. Such states will not nutritional
categorical food package undertake their science
tailoring may be done for own review of rendering food
nutritional reasons, but not WIC prescription package
to achieve cost reductions. maximums in tailoring
response to the unnecessary.
federal
revisions to the
WIC food
packages. In the
absence of this
rule, States may
have incurred
administrative
burden.
Interim rule:
Ends the practice of
categorical tailoring of WIC
food packages by States.
-$
Interim rule:
[[Page 69015]]
Allow State agencies to round Minimal cost given States may incur Unless Will ensure WIC
up to the next whole container the small some manufacturers participants get
of infant foods if needed to container sizes administrative change container the full
provide the maximum authorized involved. burden to sizes to achieve nutritional
amount of these foods. Rounding up is implement, greater product benefit
likely to require particularly if sales, no impact authorized.
the addition of manufacturers is expected.
little jarred change container
infant food to sizes in
the food response to this
packages; rule. Local
containers are agencies will
typically just need to educate
4oz. The current WIC vendors and
infant cereal participants on
maximum of 24oz rounded formula
is a multiple of amounts. MIS
a commonly systems will
prescribed need to be
package size; 8oz revised.
boxes are among
the standard
package sizes.
+$
Interim rule:
Allow State agencies to propose Will increase Because of the Minimal since Minimal since
plans for additional package administrative interim rule's very few food very few food
substitutions to meet costs of flexibility in package package
unanticipated cultural needs considering food offerings, substitutions substitutions
of participants. State proposals but States will no have ever been have ever been
agencies will only substitute little effect on longer have as permitted. permitted.
foods after receiving written program costs much, if any,
approval from FNS. since very few need to request
package substitutions to
substitutions meet cultural
have ever been preferences.
approved. Administrative
savings will
accrue for those
States that do
not pursue
substitutions.
----------------------------------------------------------------------------------------------------------------
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
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 phased-implementation
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]
----------------------------------------------------------------------------------------------------------------
FY 2008-FY
Food package FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 2012
----------------------------------------------------------------------------------------------------------------
I--Infants (0-5.9 months)......... -$12.6 -$44.4 -$53.4 -$55.8 -$58.3 -$224.5
II--Infants (6-11.9 months)....... 23.9 84.2 101.2 105.8 110.4 425.4
III--Participants with qualifying 3.0 10.6 12.8 13.4 14.0 53.8
conditions.......................
IV--Children (1-4.9 years)........ -18.4 -71.0 -92.0 -102.7 -113.8 -398.0
V--Pregnant and Partially 6.5 20.8 22.6 21.2 19.7 90.9
Breastfeeding Women..............
VI--Postpartum Women.............. 0.5 0.4 -0.9 -2.3 -3.8 -6.3
VII--Exclusively Breastfeeding 2.1 6.7 7.2 6.7 6.1 28.9
Women............................
Total......................... 5.0 7.3 -2.5 -13.9 -25.6 -29.7
----------------------------------------------------------------------------------------------------------------
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 reflect total food costs and savings. Total
costs are for FY08-FY12 and have not been adjusted for the rule's
phased implementation.
[[Page 69016]]
Table 3.--Major Cost Drivers of WIC Food Packages
------------------------------------------------------------------------
Food package Major cost drivers (2008-2012)
------------------------------------------------------------------------
I............................. Formula is reduced for
partially breastfed infants and
eliminated for fully breastfed infants
(-$172 million post rebate).
II............................ 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).
III........................... 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).
IV............................ 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).
V............................. 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).
VI............................ 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).
VII........................... Juice is reduced (-$124
million).
Milk is reduced (-$75 million).
$10 cash-value instrument for
fruits and vegetables is added (+$175
million).
------------------------------------------------------------------------
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.
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.
---------------------------------------------------------------------------
\24\ IOM, p. 172
---------------------------------------------------------------------------
4. Cost Estimate Methodology
Overview
The impacts of the interim rule on Federal expenditures are
projected by comparing 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 program-relevant 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 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 (http://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\
---------------------------------------------------------------------------
\25\ Additional information on the posted data, or on any other
aspect of this cost estimate, is available from FNS on request.
---------------------------------------------------------------------------
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
[[Page 69017]]
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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\
---------------------------------------------------------------------------
\33\ The primary DHA/ARA enhanced powder formulas prescribed by
WIC clinics for each of the manufacturers was used in computing the
weighted average.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\34\ The primary DHA/ARA enhanced powder formulas prescribed by
WIC clinics for each of the manufacturers was used in computing the
weighted average.
---------------------------------------------------------------------------
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
[[Page 69018]]
container sizes weighted over the 6 month package period.\35\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\36\ Herman, Dena and Harrison, Gail, ``Are Economic Incentives
Useful for Improving Dietary Quality among WIC participants and
their Families?'' ERS, USDA, 2004.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\37\ Food and Nutrition Service, U.S. Department of Agriculture,
``National Survey of WIC Participants'', October 2001.
Table 4.--Prescription Estimates Under Interim Rule \38\
----------------------------------------------------------------------------------------------------------------
Estimated
Maximum amount average
Food package Units \39\ per food prescribed
category \40\ amount
----------------------------------------------------------------------------------------------------------------
Infants: Food Package I
----------------------------------------------------------------------------------------------------------------
I-FF-A (0-3.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 806 842.65
I-FF-B (4-5.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 884 931.37
I-BF/FF-A (0-0.9 mo):
Formula (post-rebate)\41\.............. reconstituted fluid oz............. 104 0.00
I-BF/FF-B (1-3.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 364 390.14
I-BF/FF-C (4-5.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 442 470.66
I-BF-A (0-3.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 0 0.00
I-BF-B (4-5.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 0 0.00
----------------------------------------------------------------------------------------------------------------
Infants: Food Package II
----------------------------------------------------------------------------------------------------------------
II-FF (6-11.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 624 656.66
Cereal................................. oz................................. 24 20.10
Baby fruits & vegetables............... oz................................. 128 105.37
Bananas............................ lb................................. .............. 1.80
II-BF/FF (6-11.9 mo):
Formula (post-rebate).................. reconstituted fluid oz............. 312 355.32
Cereal................................. oz................................. 24 20.93
Baby fruits & vegetables............... oz................................. 128 105.37
Bananas............................ lb................................. .............. 1.80
II-BF (6-11.9 mo):
Cereal................................. oz................................. 24 22.27
Baby fruits & vegetables............... oz................................. 256 225.03
Bananas............................ lb................................. .............. 1.80
Infant food meat....................... oz................................. 77.5 73.06
----------------------------------------------------------------------------------------------------------------
Children: Food Package IV
----------------------------------------------------------------------------------------------------------------
IV-A (1-1.9 yrs):
Juice.................................. oz................................. 128 127.59
[[Page 69019]]
Milk (whole)........................... qt................................. 16 13.01
Cheese............................. lb................................. .............. 0.96
Cereal................................. oz................................. 36 34.39
Eggs................................... doz................................ 1 1.00
Whole grain bread...................... lb................................. 2 1.22
Other grains....................... lb................................. .............. 0.69
Beans, dried \42\...................... lb................................. 1 0.30
Beans, canned...................... oz................................. .............. 19.54
Peanut butter...................... oz................................. .............. 6.27
Fruit and vegetable voucher.\43\....... voucher ($)........................ 6.00 5.25
IV-B (2-4.9 yrs):
Juice.................................. oz................................. 128 127.59
Milk, fat-reduced...................... qt................................. 16 13.01
Cheese............................. lb................................. .............. 0.96
Cereal................................. oz................................. 36 34.39
Eggs................................... doz................................ 1 1.00
Whole grain bread...................... lb................................. 2 1.22
Other grains....................... lb................................. .............. 0.69
Beans, dried........................... lb................................. 1 0.30
Beans, canned...................... oz................................. .............. 19.54
Peanut butter...................... oz................................. .............. 6.27
Fruit and vegetable voucher.\43\....... voucher ($)........................ 6.00 5.25
----------------------------------------------------------------------------------------------------------------
Women: Food Package V
----------------------------------------------------------------------------------------------------------------
V:
Juice.................................. oz................................. 144 143.40
Milk, fat-reduced...................... qt................................. 22 16.90
Soy beverage....................... qt................................. .............. 1.66
Tofu............................... lb................................. .............. 0.05
Cheese............................. lb................................. .............. 0.97
Cereal................................. oz................................. 36 35.09
Eggs................................... doz................................ 1 1.00
Whole grain bread...................... lb................................. 1 0.63
Other grains....................... lb................................. .............. 0.35
Beans, dried \44\...................... lb................................. 1 0.60
Beans, canned...................... oz................................. .............. 38.63
Peanut butter...................... oz................................. 18 13.41
Fruit and vegetable voucher.\43\....... voucher ($)........................ 8.00 7.00
----------------------------------------------------------------------------------------------------------------
Women: Food Package VI
----------------------------------------------------------------------------------------------------------------
VI:
Juice.................................. oz................................. 96 95.54
Milk, fat-reduced...................... qt................................. 16 11.68
Soy beverage....................... qt................................. .............. 1.29
Tofu............................... lb................................. .............. 0.02
Cheese............................. lb................................. .............. 0.95
Cereal................................. oz................................. 36 34.70
Eggs................................... doz................................ 1 0.95
Beans, dried \44\...................... lb................................. 1 0.23
Beans, canned...................... oz................................. .............. 14.69
Peanut butter...................... oz................................. .............. 9.06
Fruit and vegetable voucher.\43\....... voucher ($)........................ 8.00 7.00
----------------------------------------------------------------------------------------------------------------
Women: Food Package VII
----------------------------------------------------------------------------------------------------------------
VII:
Juice.................................. oz................................. 144 143.64
Milk, fat-reduced...................... qt................................. 24 17.51
Soy beverage....................... qt................................. .............. 1.46
Tofu............................... lb................................. .............. 0.01
Cheese............................. lb................................. .............. 1.60
Cheese................................. lb................................. 1 1.00
Cereal................................. oz................................. 36 35.87
Eggs................................... doz................................ 2 1.98
Whole grain bread...................... lb................................. 1 0.63
Other grains....................... lb................................. .............. 0.35
Canned fish............................ oz................................. 30 ..............
Tuna............................... oz................................. .............. 22.44
[[Page 69020]]
Salmon, sardines, mackerel......... oz................................. .............. 6.11
Beans, dried \44\...................... lb................................. 1 0.60
Beans, canned...................... oz................................. .............. 38.63
Peanut butter.......................... oz................................. 18 13.41
Fruit and vegetable voucher.\43\....... voucher ($)........................ 10.00 8.75
----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
---------------------------------------------------------------------------
\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 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.
Table 5.--Prescription Estimates for Current Food Packages
----------------------------------------------------------------------------------------------------------------
Estimated
Maximum amount average
Food package Units \45\ per food prescribed
category amount
----------------------------------------------------------------------------------------------------------------
Infants: Food Package I
----------------------------------------------------------------------------------------------------------------
I--Fully breast-fed:
Formula................................ reconstituted fluid oz............ 806 79.58
I--Partially breast-fed:
Formula................................ reconstituted fluid oz............ 806 546.55
I--Fully formula-fed:
Formula................................ reconstituted fluid oz............ 806 906.33
----------------------------------------------------------------------------------------------------------------
Infants: Food Package II
----------------------------------------------------------------------------------------------------------------
II--Fully breast-fed 4-6.9 mo:
Formula................................ reconstituted fluid oz............ 806 77.38
Juice.................................. oz................................ 96 34.09
Cereal................................. oz................................ 24 20.63
II--Partially breast-fed 4-6.9 mo:
Formula................................ reconstituted fluid oz............ 806 613.76
Juice.................................. oz................................ 96 53.80
Cereal................................. oz................................ 24 16.60
II--Fully formula-fed 4-6.9 mo:
Formula................................ reconstituted fluid oz............ 806 906.33
Juice.................................. oz................................ 96 41.93
Cereal................................. oz................................ 24 16.99
II--Fully breast-fed 7-11.9 mo:
Formula................................ reconstituted fluid oz............ 806 77.12
Juice.................................. oz................................ 96 81.15
Cereal................................. oz................................ 24 22.28
II--Partially breast-fed 7-11.9 mo:
Formula................................ reconstituted fluid oz............ 806 637.89
Juice.................................. oz................................ 96 69.30
Cereal................................. oz................................ 24 21.08
II--Fully formula-fed 7-11.9 mo:
Formula................................ reconstituted fluid oz............ 806 906.33
Juice.................................. oz................................ 96 76.42
Cereal................................. oz................................ 24 20.27
----------------------------------------------------------------------------------------------------------------
[[Page 69021]]
Children: Food Package IV
----------------------------------------------------------------------------------------------------------------
IV:
Juice.................................. oz................................ 288 232.77
Milk................................... qt................................ 24 16.58
Cheese................................. lb................................ ............... 1.57
Cereal................................. oz................................ 36 34.39
Eggs................................... doz............................... 2.5 1.83
Beans, dried........................... lb................................ 1 0.61
Peanut butter.......................... oz................................ ............... 6.27
----------------------------------------------------------------------------------------------------------------
Women: Package V
----------------------------------------------------------------------------------------------------------------
V:
Juice.................................. oz................................ 288 267.83
Milk................................... qt................................ 28 20.94
Cheese................................. lb................................ ............... 1.84
Cereal................................. oz................................ 36 35.09
Eggs................................... doz............................... 2.5 1.99
Beans, dried........................... lb................................ 1 0.55
Peanut butter.......................... oz................................ ............... 7.29
----------------------------------------------------------------------------------------------------------------
Women: Package VI
----------------------------------------------------------------------------------------------------------------
VI:
Juice.................................. oz................................ 192 185.54
Milk................................... qt................................ 24 17.15
Cheese................................. lb................................ ............... 1.65
Cereal................................. oz................................ 36 34.70
Eggs................................... doz............................... 2.5 1.78
----------------------------------------------------------------------------------------------------------------
Women: Package VII
----------------------------------------------------------------------------------------------------------------
VII:
Juice.................................. oz................................ 336 319.32
Milk................................... qt................................ 28 22.28
Cheese as milk substitute.............. lb................................ ............... 1.65
Cheese................................. lb................................ 1 1.00
Cereal................................. oz................................ 36 35.87
Eggs................................... doz............................... 2.5 2.00
Beans, dried........................... lb................................ 1 1.20
Peanut butter.......................... oz................................ 18 13.41
Tuna................................... oz................................ 26 24.75
Carrots................................ lb................................ 2 1.99
----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\45\ Units are expressed in fluid ounces (fluid oz), ounces
(oz), pounds (lb), quarts (qt), and dozens (doz).
---------------------------------------------------------------------------
iv. Food Prices
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 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.
---------------------------------------------------------------------------
\46\ Prices displayed in Table 6 are inflated to FY 2006 levels
using Bureau of Labor Statistics CPI estimates.
\47\ Homescan data also captures purchases of non-UPC coded
(non-scannable) random weight items such as fresh produce.
---------------------------------------------------------------------------
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.)
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
income-eligible. 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
[[Page 69022]]
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 WIC-eligible
incomes. All prices are weighted by the aggregate volumes purchased
by WIC-eligible 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 category-specific 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\
---------------------------------------------------------------------------
\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.
Table 6.--WIC Foods: Food Item, Selection Criteria, Units, and Prices Per Unit
----------------------------------------------------------------------------------------------------------------
Price per unit
Food item Retail sales database Units (inflated to
selection criteria FY06)
----------------------------------------------------------------------------------------------------------------
Infant formula (post rebate):\49\
Powdered.......................... Enhanced formulas \50\ in oz...................... $0.0312
powdered, liquid concentrate,
and ready-to-feed forms.
Weighted average of all forms.\51\ .............................. oz...................... 0.0331
Infant cereal (post rebate)........... Dry grains without added fruit oz...................... 0.125
or other flavors.
Infant food:
Infant fruit and vegetables....... Any texture; plain fruits or oz...................... 0.122
vegetables.
Infant food meat.................. All plain meat varieties...... oz...................... 0.346
Bananas........................... Fresh......................... lb...................... 0.456
Milk:
Whole............................. Fresh dairy milk only, \1/2\ qt...................... 0.767
gallon or gallon containers.
Reduced fat includes skim
milk and milk identified as
2% or lower milk fat.
Reduced fat....................... .............................. qt...................... 0.708
Cheese................................ Processed American and lb...................... 3.292
domestic natural cheddar,
Colby, mozzarella, brick,
Monterey jack. Sliced or un-
sliced varieties.
Yogurt................................ Quart sized containers and qt...................... 2.068
larger. Plain, vanilla, and
fruit flavors.
Tofu.................................. Plain varieties............... lb...................... 1.467
Soy beverage.......................... Half gallon or larger sizes. qt...................... 1.370
Plain varieties.\52\.
Juice................................. Apple, grape, orange, oz...................... 0.032
grapefruit, tomato.
Unsweetened 100% juice.
Adult cereal.......................... Weighted average of cereals oz...................... 0.159
commonly prescribed by state
WIC agencies and whole-grain
varieties. Hot or ready-to-
eat.
Eggs.................................. Large or medium, white. One- doz..................... 0.931
dozen containers only.
Beans:
Dry............................... Most varieties, excluding lb...................... 0.805
string beans and immature
peas. Not mixed with other
foods.
Canned............................ .............................. oz...................... 0.037
Peanut butter......................... All forms and varieties. Not oz...................... 0.094
mixed with jelly.
Whole-grain bread..................... Wheat or grain bread.......... lb...................... 1.422
Brown rice............................ Instant or regular............ lb...................... 1.178
Tuna.................................. Chunk light, canned........... oz...................... 0.101
Other canned fish..................... Salmon, sardines and mackerel, oz...................... 0.114
canned.
Carrots............................... Fresh, frozen, canned......... lb...................... 0.953
----------------------------------------------------------------------------------------------------------------
[[Page 69023]]
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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\
---------------------------------------------------------------------------
\53\ See IOM, p. 140.
---------------------------------------------------------------------------
vi. Phased Implementation
The analysis assumes the rule takes effect in December 2007
(FY08). During the phase-in 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.
---------------------------------------------------------------------------
\54\ If 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.
---------------------------------------------------------------------------
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, 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
[[Page 69024]]
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 FY 2009 FY 2010 FY 2011 FY 2012 Total
----------------------------------------------------------------------------------------------------------------
Cost/Savings of Rule with 10% Increase in -$5.8 -$30.8 -$48.4 -$61.8 -$75.7 -$222.5
Dairy Prices.................................
Cost/Savings of Interim Rule.................. 5.0 7.3 -2.5 -13.9 -25.6 -29.7
Difference Between Base Assumption and 10% 10.8 38.2 45.9 47.9 50.0 192.8
Price Increase...............................
Cost/Savings of Rule with 10% Decrease in 15.8 45.5 43.3 34.0 24.4 163.1
Dairy Prices.................................
Cost/Savings of Interim Rule.................. 5.0 7.3 -2.5 -13.9 -25.6 -29.7
Difference Between Base Assumption and 10% -10.8 -38.2 -45.9 -47.9 -50.0 -192.8
Price Decrease...............................
----------------------------------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\55\ AC Nielsen Homescan data indicate that approximately 10% of
households with WIC-eligible 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.
---------------------------------------------------------------------------
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 FY 2009 FY 2010 FY 2011 FY 2012 Total
----------------------------------------------------------------------------------------------------------------
Cost/Savings of Rule with alternate 5% $1.5 -$4.9 -$17.2 -$29.2 -$41.6 -$91.4
prescription rate............................
Cost/Savings of Interim Rule.................. 5.0 7.3 -2.5 -13.9 -25.6 -29.7
Difference Between Base Assumption and 5% 3.5 12.2 14.7 15.3 16.0 61.6
Prescription Rate........................
Cost/Savings of Rule with alternate 15% 8.4 19.5 12.1 1.4 -9.6 31.9
prescription rate............................
Cost/Savings of Interim Rule.................. 5.0 7.3 -2.5 -13.9 -25.6 -29.7
Difference Between Base Assumption and 15% -3.5 -12.2 -14.7 -15.3 -16.0 -61.6
Prescription Rate........................
----------------------------------------------------------------------------------------------------------------
Negative values are cost reductions. Differences may not be exact due to rounding.
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
[[Page 69025]]
large shift to the partially breastfeeding 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 Infant Pair
----------------------------------------------------------------------------------------------------------------
Fully Formula Fed Feeding Pair.................................. $31.23 $27.90 $59.14
Partially Breast Fed Feeding Pair............................... 40.09 3.25 43.34
Cost/Savings of Moving to Partially Breast Fed Packages..... $8.86 -$24.66 -$15.80
Fully Breast Fed Feeding Pair................................... 51.30 0.00 51.30
Partially Breast Fed Feeding Pair............................... 40.09 3.25 43.34
Cost/Savings of Moving to Partially Breast Fed Packages..... -$11.21 $3.25 -$7.96
----------------------------------------------------------------------------------------------------------------
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 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%. For packages V and VII,
FNS applied an observed average rate of 97.7%.
---------------------------------------------------------------------------
\57\ Observed rates were taken from PC2002.
---------------------------------------------------------------------------
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 FY 2009 FY 2010 FY 2011 FY 2012 Total
----------------------------------------------------------------------------------------------------------------
Cost/Savings of Rule with 90% Whole Grain $2.6 $1.2 -$12.8 -$24.6 -$36.8 -$72.9
Prescription Rate............................
Cost/Savings of Interim Rule.................. 5.0 7.3 -2.5 -13.9 -25.6 -29.7
Difference Between Base Assumption and 90% $2.4 $8.5 $10.3 $10.7 $11.2 $43.1
Prescription Rate........................
Cost/Savings of Rule with 100% Whole Grain 6.8 13.7 5.1 -5.9 -17.3 2.5
Prescription Rate............................
Cost/Savings of Interim Rule.................. 5.0 7.3 -2.5 -13.9 -25.6 -29.7
Difference Between Base Assumption and -$1.8 -$6.4 -$7.7 -$8.0 -$8.4 -$32.3
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
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 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\
---------------------------------------------------------------------------
\58\ Because the estimate assumes no rounding up of jarred
infant foods, the net average prescription 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 maximum monthly allowance of 77.5 oz is evenly divisible by the
most commonly marketed jar size.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Cost/Savings of Rule with 90% $2.1 -$2.7 -$14.6 -$26.5 -$38.8 -$80.4
Infant Food Prescription Rate....
Cost/Savings of Interim Rule...... 5.0 7.3 -2.5 -13.9 -25.6 -29.7
-----------------------------------------------------------------------------
Difference Between Base 2.8 10.0 12.0 12.6 13.1 50.6
Assumption and 90%
Prescription Rate............
----------------------------------------------------------------------------------------------------------------
Cost/Savings of Rule with 100% 8.7 20.4 13.1 2.5 -8.6 36.0
Infant Food Prescription Rate....
Cost/Savings of Interim Rule...... 5.0 7.3 -2.5 -13.9 -25.6 -29.7
-----------------------------------------------------------------------------
Difference Between Base -3.7 -13.0 -15.6 -16.3 -17.1 -65.8
Assumption and 100%
Prescription Rate............
----------------------------------------------------------------------------------------------------------------
[[Page 69026]]
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 WIC-eligible 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..... $25.1 $78.4 $82.9 $75.4 $67.6 $329.3
Cost/Savings of Interim Rule...... 5.0 7.3 -2.5 -13.9 -25.6 -29.7
-----------------------------------------------------------------------------
Difference Between Base -20.1 -71.0 -85.4 -89.3 -93.2 -359.1
Assumption and Scenario 1....
----------------------------------------------------------------------------------------------------------------
Savings of Rule Under Scenario 2.. -14.2 -60.3 -83.8 -98.8 -114.3 -371.4
Cost/Savings of Interim Rule...... 5.0 7.3 -2.5 -13.9 -25.6 -29.7
-----------------------------------------------------------------------------
Difference Between Base 19.2 67.6 81.3 84.9 88.7 341.6
Assumption and Scenario 2....
----------------------------------------------------------------------------------------------------------------
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 $.71 per quart for reduced-fat milk, considerably
increases the monthly cost of Food Packages IV-VII. Soy beverage and
tofu also have higher per unit costs than milk; however, the
estimated amount of tofu purchased by WIC participants is
substantially lower than that of yogurt, and soy beverage is priced
lower than yogurt ($.70 less per quart) making it a more cost-
efficient substitute.
Table 13.--Projected Cost of Yogurt as a Milk Substitute
------------------------------------------------------------------------
Estimated
average Price per Cost per
Food package prescribed unit food
amount (inflated package
(qt.) to FY06)
------------------------------------------------------------------------
IV............................... 0.86 $2.07 $1.78
V................................ 0.84 2.07 1.74
VI............................... 0.66 2.07 1.37
VII.............................. 0.83 2.07 1.72
------------------------------------------------------------------------
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
this alternative, is $384.0 million. The cost of the interim rule
without yogurt is -$29.7 million (see Table 2). Therefore, the
elimination of yogurt is retained in this interim rule.
[[Page 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 $28.2 $89.2 $95.9 $88.9 $81.8 $384.0
Assumption.......................
Total Cost of Interim Rule........ 5.0 7.3 -2.5 -13.9 -25.6 -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 $25.2 $78.7 $83.3 $75.8 $68.0 $331.1
Alternative................
Total Cost of Interim Rule.. 5.0 7.3 -2.5 -13.9 -25.6 -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\
---------------------------------------------------------------------------
\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).
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 $1.0 -$11.0 -$27.6 -$44.6 -$50.9 -$133.2
Alternative......................
Total Cost of Interim Rule........ 5.0 7.3 -2.5 -13.9 -25.6 -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.
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
[[Page 69028]]
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.
---------------------------------------------------------------------------
\60\ IOM, p. 103.
---------------------------------------------------------------------------
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 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.
---------------------------------------------------------------------------
\61\ United Soybean Board, Current Knowledge on Soy and
Children's Diets, August 2004, prepared by N. Chapman and
Associates. http://www.soyfoods.org/wp-content/uploads/2006/11/soy_and_child_diet.pdf
.
---------------------------------------------------------------------------
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.
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.
---------------------------------------------------------------------------
\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 Nutrition Research
Report Number 19-3. October 2004.
---------------------------------------------------------------------------
We estimated the total value of WIC sales\63\ 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.
---------------------------------------------------------------------------
\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 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%.
---------------------------------------------------------------------------
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 Interim food package
---------------------------------------------------------------------------------------------------------
WIC food item WIC % of WIC % of
Estimated total Estimated total WIC market Estimated total Estimated total WIC market
annual sales ($) sales ($) \66\ \67\ annual sales ($) sales ($) \67\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formula....................................... 3,600,257,587 2,533,590,541 70.4 3,600,257,587 2,025,525,861 56.3
Beans......................................... 874,176,643 32,179,354 3.7 874,176,643 82,632,904 9.5
Peanut butter................................. 1,133,273,041 40,935,940 3.6 1,133,273,041 54,492,515 4.8
Milk.......................................... 16,043,036,006 975,287,323 6.1 16,043,036,006 712,840,678 4.4
Adult cereal.................................. 9,697,058,781 399,336,655 4.1 9,697,058,781 399,336,655 4.1
Juice......................................... 14,203,760,671 556,756,383 3.9 14,203,760,671 281,143,313 2.0
Rice.......................................... 737,198,377 0 ......... 737,198,377 43,442,898 5.9
Fruit and vegetables.......................... 15,761,934,300 7,512,820 0.0 15,761,934,300 431,691,818 2.7
Eggs.......................................... 2,959,401,900 120,241,255 4.1 2,959,401,900 67,192,054 2.3
Cheese........................................ 12,329,016,799 386,210,204 3.1 12,329,016,799 247,273,210 2.0
Bread......................................... 17,028,860,749 0 ......... 17,028,860,749 93,740,564 0.6
Canned fish................................... 1,917,928,393 9,191,549 0.5 1,917,928,393 10,885,456 0.6
Infant cereal \68\............................ ................... 56,640,143 ......... ................... 42,641,463 .........
Baby food \68\................................ ................... 0 ......... ................... 185,899,515 .........
Tofu \68\..................................... ................... 0 ......... ................... 1,088,288 .........
Soy beverage \68\............................. ................... 0 ......... ................... 49,561,168 .........
---------------------------------------------------------------------------------------------------------
[[Page 69029]]
Total..................................... 96,285,903,247 5,117,882,167 6.4 96,285,903,247 4,729,388,359 4.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\66\ Total WIC sales reported here are less than the $5.3
billion (pre-rebate) reported in WIC 2005 food costs. The estimates
of total WIC food sales for the current and proposed packages are
likely to be lower than actual WIC food expenditures because the AC
Nielsen Productscan and Homescan data used to estimate food prices
may not fully capture the higher prices charged by WIC vendors such
as small, non-chain, convenience and ``WIC-Only'' stores.
\67\ ``WIC % of Market'' estimates are calculated only for items
for which we have both a numerator and denominator.
\68\ We were unable to assess the market impact of infant
cereal, baby food, tofu and soy beverage items in the WIC food
package. These items are not included in the Productscan data;
however, we are able to estimate WIC sales because these items are
part of the Homescan data, which is our source for item price data.
Table 18.--Estimated Total Annual Sales, WIC Sales, and WIC Percent of Market for Current Food Package and Interim Food Package, Assuming No
Substitution of WIC Foods in Total Annual Sales, CY2005
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current Food Package Interim food package
---------------------------------------------------------------------------------------------------------
WIC food item WIC % of WIC % of
Estimated total Estimated total WIC market Estimated total Estimated total WIC market
annual sales ($) sales ($) \69\ \70\ annual sales ($) sales ($) \70\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formula....................................... 3,600,257,587 2,533,590,541 70.4 3,092,192,907 2,025,525,861 65.5
Beans......................................... 874,176,643 32,179,354 3.7 924,630,192 82,632,904 8.9
Peanut butter................................. 1,133,273,041 40,935,940 3.6 1,146,829,616 54,492,515 4.8
Milk.......................................... 16,043,036,006 975,287,323 6.1 15,780,589,361 712,840,678 4.5
Adult cereal.................................. 9,697,058,781 399,336,655 4.1 9,697,058,781 399,336,655 4.1
Juice......................................... 14,203,760,671 556,756,383 3.9 13,928,147,601 281,143,313 2.0
Rice.......................................... 737,198,377 0 780,641,275 43,442,898 5.6
Fruit and vegetables.......................... 15,761,934,300 7,512,820 0.0 16,186,113,298 431,691,818 2.7
Eggs.......................................... 2,959,401,900 120,241,255 4.1 2,906,352,699 67,192,054 2.3
Cheese........................................ 12,329,016,799 386,210,204 3.1 12,190,079,804 247,273,210 2.0
Bread......................................... 17,028,860,749 0 ......... 17,122,601,313 93,740,564 0.5
Canned fish................................... 1,917,928,393 9,191,549 0.5 1,919,622,300 10,885,456 0.6
Infant cereal \71\............................ ................... 56,640,143 ......... ................... 42,641,463
Baby food \71\................................ ................... 0 ......... ................... 185,899,515
Tofu \71\..................................... ................... 0 ......... ................... 1,088,288
Soy beverage) \71\............................ ................... 0 ......... ................... 49,561,168
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total..................................... 96,285,903,247 5,117,882,167 6.4 95,674,859,149 4,729,388,359 4.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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%,
[[Page 69030]]
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 WIC-provided 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 two-thirds 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%).
---------------------------------------------------------------------------
\72\ Victor Oliveira, Mark Prell, David Smallwood, Elizabeth
Fraz[atilde]o, WIC and the Retail Price of Infant Formula, Economic
Research Service, U.S. Department of Agriculture, May 2004, p. 60.
---------------------------------------------------------------------------
Appendix A: Additional Cost Estimate Assumptions
Table A1.--FY 08 Food Package Costs
[Monthly costs, post-rebate]
------------------------------------------------------------------------
Food package Current Interim
------------------------------------------------------------------------
I--0 to 5.9 month infants \73\.................... $24.49 $20.84
II--6 to 11.9 month infants....................... 33.32 41.06
III--Participants with qualifying conditions \74\. 0.00 21.07
IV--Children 1 to 4.9 years....................... 35.18 34.49
V--Women: Pregnant and partially breastfeeding.... 39.82 42.66
VI--Women: Postpartum............................. 32.15 33.38
VII--Women: Fully breastfeeding................... 51.23 54.56
------------------------------------------------------------------------
---------------------------------------------------------------------------
\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 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.]
Table A2.--Annual Current Food Package Costs (Post-Rebate) FY08-FY12
[In $ millions]
----------------------------------------------------------------------------------------------------------------
Food package FY08 \75\ FY09 FY10 FY11 FY12
----------------------------------------------------------------------------------------------------------------
I.............................................. $272.18 $342.02 $357.69 $373.79 $390.35
II............................................. 331.53 416.59 435.68 455.29 475.46
III \74\....................................... 0.00 0.00 0.00 0.00 0.00
IV............................................. 1,454.11 1,827.21 1,910.94 1,996.95 2,085.41
V.............................................. 456.17 573.22 599.49 626.47 654.22
VI............................................. 206.42 259.39 271.27 283.48 296.04
VII............................................ 169.47 212.95 222.71 232.74 243.05
----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\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.
[[Page 69031]]
Table A3.--Annual Interim Food Package Costs (Post-Rebate) FY08-FY12
[In $ millions]
----------------------------------------------------------------------------------------------------------------
Food package FY08 \75\ FY09 FY10 FY11 FY12
----------------------------------------------------------------------------------------------------------------
I.............................................. $259.58 $297.59 $304.29 $317.98 $332.07
II............................................. 355.40 500.78 536.88 561.05 585.90
III \74\....................................... 3.02 10.64 12.79 13.36 13.95
IV............................................. 1,435.66 1,756.20 1,818.93 1,894.24 1,971.64
V.............................................. 462.71 594.06 622.09 647.66 673.95
VI............................................. 206.88 259.75 270.33 281.14 292.25
VII............................................ 171.61 219.70 229.93 239.41 249.14
----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\75\ For both the current and interim rules, FY 08 figures
represent just 10 months (the interim rule will be effective for
just 10 months of the year.) The interim rule figures are not fully
phased-in until FY 2010.
Table B.--CY05 to FY06 Price Inflation Assumptions--Food Specific CPIs
------------------------------------------------------------------------
Inflation
Food item rate
(percent)
------------------------------------------------------------------------
Infant Formula............................................. 1.3
Infant cereal.............................................. -1.7
Infant food fruit and vegetables........................... 2.5
Infant food meat........................................... 2.5
Bananas.................................................... 4.2
Milk:
Whole.................................................... -0.7
Reduced fat.............................................. -0.5
Cheese..................................................... -0.9
Yogurt..................................................... -0.3
Tofu....................................................... 1.3
Soy beverage............................................... 1.3
Juice...................................................... 3.9
Adult cereal:
Whole grain.............................................. -1.7
Current WIC cereals...................................... -1.7
Eggs....................................................... 2.9
Beans:
Dry...................................................... 1.0
Canned................................................... 1.0
Peanut butter.............................................. 0.9
Whole grain bread.......................................... 3.2
Brown rice................................................. 3.7
Tuna....................................................... 2.5
Canned Fish................................................ 2.5
Carrots.................................................... 3.4
------------------------------------------------------------------------
Table C.--Inflation Assumptions, FY05-FY12
------------------------------------------------------------------------
CPI: fruit
Thrifty and
Year food plan vegetables
(% change) (% change)
------------------------------------------------------------------------
FY05 *........................................ -0.32 3.74
FY06 *........................................ -0.75 4.76
FY07 *........................................ 2.05 1.03
FY08.......................................... 2.62 1.96
FY09.......................................... 2.58 1.88
FY10.......................................... 2.45 1.92
FY11.......................................... 2.37 1.92
FY12.......................................... 2.30 1.92
------------------------------------------------------------------------
*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 FY09 FY10 FY11 FY12
----------------------------------------------------------------------------------------------------------------
I
0-3.9 month Infants:
Fully formula-fed........... 426,994 435,882 444,956 454,218 463,674
Partially breast-fed........ 112,821 115,169 117,567 120,014 122,513
Fully breast-fed............ 199,996 204,159 208,409 212,747 217,176
-------------------------------------------------------------------------------
Subtotal................ 739,810 755,211 770,932 786,980 803,362
II
4-5.9 month Infants:
Fully formula-fed........... 283,539 289,441 295,466 301,617 307,895
Partially breast-fed........ 31,566 32,223 32,894 33,579 34,278
Fully breast-fed............ 56,262 57,433 58,628 59,849 61,095
6-11.9 month Infants:
Fully formula-fed........... 840,456 857,952 875,811 894,043 912,654
Partially breast-fed........ 56,380 57,554 58,752 59,975 61,224
Fully breast-fed............ 98,114 100,156 102,241 104,369 106,542
-------------------------------------------------------------------------------
Subtotal................ 1,366,316 1,394,759 1,423,793 1,453,432 1,483,687
III
Participants with qualifying 92,470 94,395 96,360 98,366 100,414
conditions \76\................
IV
Children: 1-4.9 years........... 4,133,746 4,219,798 4,307,640 4,397,311 4,488,849
V
Women:
Pregnant.................... 958,254 978,202 998,564 1,019,351 1,040,571
Partially breastfeeding..... 187,421 191,323 195,305 199,371 203,521
-------------------------------------------------------------------------------
Subtotal................ 1,145,675 1,169,524 1,193,870 1,218,722 1,244,092
[[Page 69032]]
VI
Women: Postpartum............... 642,045 655,410 669,054 682,981 697,198
VII
Women: Fully breastfeeding...... 330,813 337,700 344,730 351,906 359,231
-------------------------------------------------------------------------------
Total................... 8,450,876 8,626,796 8,806,378 8,989,698 9,176,834
----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------
\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 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 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.
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........... 426,994 435,882 444,956 454,218 463,674
Partially breast-fed........ 112,821 115,169 117,567 120,014 122,513
Fully breast-fed............ 199,996 204,159 208,409 212,747 217,176
4-5.9 month Infants:
Fully formula-fed........... 283,539 289,441 295,466 301,617 307,895
Partially breast-fed........ 31,566 32,223 32,894 33,579 34,278
Fully breast-fed............ 56,262 57,433 58,628 59,849 61,095
-------------------------------------------------------------------------------
Subtotal................ 1,111,176 1,134,307 1,157,920 1,182,024 1,206,630
II
6-11.9 month Infants:
Fully formula-fed........... 840,456 857,952 875,811 894,043 912,654
Partially breast-fed........ 56,380 57,554 58,752 59,975 61,224
Fully breast-fed............ 98,114 100,156 102,241 104,369 106,542
-------------------------------------------------------------------------------
Subtotal................ 994,950 1,015,662 1,036,805 1,058,387 1,080,420 *
III
Participants with qualifying 92,470 94,395 96,360 98,366 100,414
conditions \76\
IV
Children:
1-1.9 years................. 1,364,955 1,393,369 1,422,374 1,451,984 1,482,209
2-4.9 years................. 2,768,791 2,826,428 2,885,265 2,945,327 3,006,639
-------------------------------------------------------------------------------
Subtotal................ 4,133,746 4,219,798 4,307,640 4,397,311 4,488,849
V
Women:
Pregnant.................... 958,254 978,202 998,564 1,019,351 1,040,571
Partially breastfeeding..... 187,421 191,323 195,305 199,371 203,521
-------------------------------------------------------------------------------
Subtotal................ 1,145,675 1,169,524 1,193,870 1,218,722 1,244,092
VI
Women: Postpartum 642,045 655,410 669,054 682,981 697,198
VII
-------------------------------------------------------------------------------
Women: Fully breastfeeding 330,813 337,700 344,730 351,906 359,231
Total................... 8,450,876 8,626,796 8,806,378 8,989,698 9,176,834
----------------------------------------------------------------------------------------------------------------
[FR Doc. E7-23033 Filed 12-5-07; 8:45 am]
BILLING CODE 3410-30-P