[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Rules and Regulations]
[Pages 12274-12300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04105]



[[Page 12273]]

Vol. 79

Tuesday,

No. 42

March 4, 2014

Part II





Department of Agriculture





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Food and Nutrition Service





7 CFR Part 246





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

  Federal Register / Vol. 79 , No. 42 / Tuesday, March 4, 2014 / Rules 
and Regulations  

[[Page 12274]]


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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 (FNS), USDA.

ACTION: Final rule.

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SUMMARY: This final rule considers public comments submitted in 
response to the interim rule revising the WIC food packages published 
on December 6, 2007. The interim rule implemented the first 
comprehensive revisions to the WIC food packages since 1980. The 
interim rule revised regulations governing the WIC food packages to 
align them more closely with updated nutrition science and the infant 
feeding practice guidelines of the American Academy of Pediatrics, 
promote and support more effectively 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. This rule makes adjustments that improve clarity of 
the provisions set forth in the interim rule.

DATES: Effective Date: This rule is effective May 5, 2014.
    Implementation Dates:
     State agencies must implement the provision in Table 2 at 
7 CFR 246.10(e)(10) increasing the cash-value voucher for children to 
$8 per month no later than June 2, 2014.
     The provision found at 7 CFR 246.12(f)(4) requiring split 
tender for cash-value vouchers shall be implemented no earlier than 
October 1, 2014 and no later than April 1, 2015.
     Footnote 11 of Table 2 at 7 CFR 246.10(e)(10) shall be 
implemented on the later of October 1, 2014, or the date on which the 
State agency exercises their option to issue authorized soy-based 
beverage or tofu to children who receive Food Package IV.
     The provisions in Footnote 10 of Table 2 at 7 CFR 
246.10(e)(10) and Footnote 12 of Table 3 at 7 CFR 246.10(e)(11) 
authorizing yogurt for children and women in Food Packages III-VII may 
be implemented no earlier than April 1, 2015.

FOR FURTHER INFORMATION CONTACT: Anne Bartholomew, Chief, Nutrition 
Services Branch, Supplemental Food Programs Division, Food and 
Nutrition Service, USDA, 3101 Park Center Drive, Room 522, Alexandria, 
Virginia 22302, (703) 305-2746 OR [email protected].

SUPPLEMENTARY INFORMATION: 

I. Overview

    This final rule addresses public comments submitted in response to 
the interim rule revising the WIC food packages published on December 
6, 2007 (72 FR 68966), and makes adjustments that improve clarity of 
the provisions set forth in the interim rule.

II. Background

    An interim rule revising the WIC food packages was published in the 
Federal Register on December 6, 2007 (72 FR 68966). The interim rule 
implemented the first comprehensive revisions to the WIC food packages 
since 1980 and largely reflected recommendations made by the National 
Academies' Institute of Medicine (IOM) in its Report ``WIC Food 
Packages: Time for a Change'' (``Report'').\1\ The interim rule aligned 
the food packages more closely with updated nutrition science, promoted 
and supported more effectively the establishment of successful long-
term breastfeeding, provided WIC participants with a wider variety of 
food, and provided WIC State agencies with greater flexibility in 
prescribing food packages to accommodate participants with cultural 
food preferences. WIC State agencies were required to implement the 
changes by October 1, 2009.
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    \1\ Institute of Medicine, National Academy of Sciences. ``WIC 
Food Packages: Time for a Change,'' 2005. Available at Internet 
site: http://www.fns.usda.gov/wic-food-packages-time-change.
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III. General Summary of Comments Received on the Interim Rule To Revise 
the WIC Food Packages

    The interim rule revising the WIC food packages provided an 
extensive public comment period to obtain comments on the impact of the 
changes experienced during implementation of the new food packages. The 
interim rule comment period ended February 1, 2010.
    A total of 7,764 comment letters were received on the interim rule; 
of those, 111 were form letters. A total of 6,664 of the letters were 
from program participants, and included comments submitted in Spanish, 
Chinese, and other languages, in addition to English. The remaining 
comment letters were submitted from a 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, commenters expressed broad support for the changes and 
reported relatively smooth implementation of the new WIC food packages. 
Commenters also voiced concerns about various aspects of the interim 
rule and made recommendations for clarifying or improving specific 
provisions of the interim rule. Overall, participants expressed 
overwhelming support for the revised WIC food packages, especially the 
addition of whole grains and fruits and vegetables. However, many 
participants who were enrolled in WIC during the transition from the 
previous food packages to the revised food packages expressed 
displeasure with changes to fat-reduced milks and less cheese.
    FNS considered all timely 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.
    WIC State agencies are to be commended for the staff and vendor 
training that led to successful implementation of the new WIC food 
packages, as well as nutrition education provided to participants on 
the benefits of the new foods in the WIC food packages. Successful 
implementation of the new WIC food packages was further enhanced by the 
efforts of WIC's partners in the advocacy, retail, and medical 
communities.

IV. Discussion of the Final Rule Provisions

    The following is a discussion of the major provisions set forth in 
this final rule, a brief summary of the comments received on the 
interim rule that addressed these issues, and FNS' rationale for either 
modifying or retaining provisions in this final rule. Provisions not 
addressed in the preamble to this final rule did not receive 
significant or substantial public comments and remain unchanged.
    The preamble to this final rule articulates the basis and purpose 
behind significant changes from the December 6, 2007 interim rule. The 
reasons supporting provisions of the interim

[[Page 12275]]

regulations were carefully examined in light of the comments received 
to determine the continued applicability of the justifications. Unless 
otherwise stated, or unless inconsistent with this final rule or this 
preamble, the rationales contained in the preamble to the proposed and 
interim regulations should be regarded as the basis for this final 
rule. Therefore, a thorough understanding of the rationales for the 
interim regulations may require reference to the preamble of the August 
7, 2006 proposed rule (71 FR 44784) and the December 6, 2007 interim 
rule (72 FR 68966).

A. Definitions

    The following definitions have been added or modified in the final 
rule.
    Farmers' market. As described in a subsequent section of this 
preamble, this final rule adds the definition of ``farmers' markets'' 
at 7 CFR 246.2.
    Full nutrition benefit. As described in a subsequent section of 
this preamble, this final rule adds the definition of ``full nutrition 
benefit'' at 7 CFR 246.2.
    WIC-eligible medical foods. Based on review and discussion with the 
Food and Drug Administration (FDA), this final rule changes the name of 
the food category ``WIC-eligible medical food'' to ``WIC-eligible 
nutritionals,'' but does not substantively change this food category. 
This nomenclature modification better describes the group of special 
WIC-eligible nutritional products the WIC Program provides to 
participants with qualifying conditions, and alleviates confusion 
associated with the use of the term ``medical food,'' which is defined 
by regulations governing FDA and differs from the WIC use of this term. 
The FNS definition for ``WIC-eligible medical food'' and the FDA 
definition for ``medical food'' are both comprehensive and detailed. 
Although the definition of ``WIC-eligible medical food'' closely aligns 
with the FDA definition for ``medical food,'' there are slight 
differences, such that some, but not all ``WIC-eligible medical foods'' 
meet FDA's definition of ``medical food.'' In an effort to alleviate 
confusion, and distinguish between the two product categories and 
definitions, FNS is modifying the name of the food category from ``WIC-
eligible medical food'' to ``WIC-eligible nutritionals.'' Other than 
the name change, the definition for this food category put forth in the 
interim rule remains unchanged in this final rule.

B. General Provisions That Affect All WIC Food Packages

1. Nutrition Tailoring
    Prior to the interim rule, FNS policy allowed 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, public health concerns, 
cultural eating patterns, and State established policies. The interim 
rule prohibits categorical nutrition tailoring, but continues to allow 
individual nutrition tailoring based on the Competent Professional 
Authority's (CPA) assessment of a participant's supplemental nutrition 
needs.
    A total of 33 commenters (of these, 8 were form letters) opposed 
the provision that prohibits categorical tailoring, stating that State 
agencies need the flexibility to propose modifications to food packages 
that respond to rapid changes in food industry, science, dietary 
recommendations, demographics, and other factors. Commenters asked that 
State agencies be able to request approval for categorical tailoring to 
meet nutritional needs and preferences.
    As stated in the preamble to the interim rule, the IOM conducted a 
full, independent and rigorous scientific review of the nutritional 
needs of WIC participants prior to recommending the quantities and 
types of WIC foods to address those needs in its Report. In addition, 
Section 232 of Public Law 111-296 amended Section 17(f)(11)(C) of the 
Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by requiring 
the Secretary to conduct, as often as necessary, but not less than 
every 10 years, 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 conducted as needed and used to determine the need for modification 
of current WIC food packages. FNS believes that this is the appropriate 
process for changes to the WIC food packages and 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 final rule 
at 7 CFR 246.10(c).
2. Cultural Food Package Proposals
    The interim rule allows State agencies to submit to FNS a plan for 
substitution of food(s) to allow for different cultural eating 
patterns. The interim rule includes criteria for submitting plans for 
substitutions and the criteria FNS will use to evaluate such plans. A 
total of 26 commenters (8 form letters) asked FNS to change the 
criterion that ``any proposed substitute food must be nutritionally 
equivalent or superior to the food it is intended to replace'' to be 
less restrictive and easier to satisfy.
    The increased variety and choice in the supplemental foods in the 
interim rule, as recommended by the IOM, provide State agencies 
expanded flexibility in prescribing culturally appropriate packages for 
diverse groups. Further, the interim rule allows State agencies 
flexibility to meet unanticipated cultural needs of participants by 
submitting plans for substitutions. The criteria are not meant to 
preclude justifiable cultural substitution proposals submitted by WIC 
State agencies, but are intended to ensure that WIC food substitutions 
maintain the nutritional integrity of the WIC foods they replace. FNS 
will continue to make determinations on proposed plans for cultural 
substitutions based on existing evaluation criteria as appropriate. 
Therefore, the criteria for submitting State agency plans for 
substitutions for different cultural eating patterns and the criteria 
FNS will use to evaluate such plans are retained at 7 CFR 246.10(i).
    The interim rule increased the variety and number of substitutions 
available for several WIC foods. This final rule further increases the 
number of substitutions and options available, i.e., yogurt, canned 
jack mackerel, and whole wheat macaroni (pasta) products. These 
additions are within the context of the IOM recommendations. FNS 
believes that these changes already provide substantial flexibility for 
prescribing food packages and that further modifications of the current 
WIC food packages are best determined through future scientific reviews 
of the WIC food packages. FNS will, therefore, not accept WIC State 
agency plans for substitutions of WIC foods for reasons other than to 
accommodate cultural eating patterns as provided for in 7 CFR 
246.10(i).
3. Medical Documentation and Supervision Requirements
a. Milk and Milk Alternatives
    Under the interim rule, medical documentation by a health care 
professional licensed to write medical

[[Page 12276]]

prescriptions is required for the issuance of certain milk alternatives 
for children and women. A total of 180 comment letters (53 of these 
form letters) opposed this requirement, primarily the documentation for 
children to receive soy-based beverage. Commenters stated that the 
provision is unnecessary, costly and burdensome for participants and 
physicians, creates barriers to services, and undermines FNS' efforts 
to provide foods that meet the cultural needs of participants. The NWA 
and the American Dietetic Association (now known as the Academy of 
Nutrition and Dietetics) stressed that WIC dietitians and nutritionists 
are trained health professionals capable of doing a complete nutrition 
assessment, selecting WIC foods, and providing appropriate education to 
participants and caregivers, in consultation with the health care 
provider when warranted.
    Based on the experiences cited by WIC State and local agencies 
related to medical documentation throughout implementation of the new 
food packages, FNS will no longer require a health care professional 
licensed to write medical prescriptions to provide documentation for 
children to receive soy-based beverage and tofu as milk substitutes. 
Also, FNS will no longer require documentation from a health care 
professional licensed to write medical prescriptions for women to 
receive tofu in excess of the maximum substitution allowance. Instead, 
consistent with IOM recommendations for documentation from a ``WIC 
recognized medical authority,'' FNS will allow the CPA to determine and 
document the need for tofu and soy-based beverage as substitutes for 
milk for children, as established by State agency policy. Such 
determination must be based on individual nutritional assessment, as 
required under the interim rule and retained in this final rule at 7 
CFR 246.10(b)(2)(ii)(C), and consultation with the participant's health 
care provider, as appropriate. Such determination can be made for 
situations that include, but are not limited to, milk allergy, lactose 
intolerance, and vegan diets. As previously discussed, the interim rule 
revised regulations governing the WIC food packages to, among other 
things, accommodate participants with cultural food preferences. Since 
cultural practices may affect nutrient intake, FNS will allow soy for 
cultural practices that prevent participants from including in their 
diets cow's milk and lactose-free or lactose-reduced fortified dairy 
products in amounts that meet their nutritional needs.
    FNS will allow the CPA, as established by State agency policy, to 
determine the need for tofu in quantities that exceed the maximum 
substitution rates. Such determination can be made for situations that 
include, but are not limited to, milk allergy, lactose intolerance, and 
vegan diets.
    FNS believes that allowing the CPA to make determinations for milk 
substitutes is consistent with IOM recommendations for documentation 
from a ``WIC recognized medical authority.'' Although FNS is no longer 
requiring documentation from a health care professional licensed to 
write medical prescriptions, it is incumbent upon WIC State agencies to 
ensure that participants and caregivers receive education that stresses 
the importance of milk over milk substitutes, and that appropriate 
policies and procedures are in place for appropriate issuance of milk 
substitutes. Parents and caregivers should be made aware that 
children's diets may be nutritionally inadequate when milk is replaced 
by other foods, and provided appropriate nutrition education. The value 
of milk for WIC participants, particularly in the development of bone 
mass for children, should be emphasized. Lactose-free or lactose-
reduced fortified dairy products should be offered before non-dairy 
milk alternatives to those participants with lactose intolerance that 
cannot drink milk. Also, if milk is replaced by milk alternatives that 
are not vitamin D fortified, vitamin D intakes may be inadequate. Thus, 
replacements for milk are to be approached with caution even if they 
are rich in calcium.
    Therefore, Table 2 of 7 CFR 246.10(e)(10) of this final rule 
requires that issuance of tofu and soy-based beverage as substitutes 
for milk for children be based on an individual nutritional assessment 
by the CPA, in consultation with the participant's health care provider 
as appropriate. Table 2 of 7 CFR 246.10(e)(10) allows the CPA, as 
established by State agency policy, to determine the need for women to 
receive tofu in excess of the maximum substitution allowance.
b. Technical Requirements for Medical Documentation
    Under the interim rule, technical requirements for medical 
documentation were established. A total of 51 comments opposed the 
provision requiring health care providers to prescribe the supplemental 
foods and quantities appropriate for a participant's qualifying 
condition in Food Package III (for participants with qualifying 
conditions). Commenters believe that medical documentation, especially 
for authorization of supplemental foods in Food Package III, is 
burdensome to State agencies, participants and the medical community. 
Commenters stated that this provision has little value since the foods 
could otherwise be purchased by the participants at grocery stores. 
Commenters also stated that the WIC nutritionist or registered 
dietitian is capable of determining appropriate amounts and types of 
supplemental foods to issue to participants based on a nutrition 
assessment of the participant.
    Due to the nature of the health conditions of participants who are 
issued supplemental foods in Food Package III, close medical 
supervision is essential for each participant's dietary management. FNS 
considers it appropriate that the responsibility for this close medical 
supervision remain with the participant's health care provider. Medical 
documentation requirements for specific supplemental foods that do not 
usually require a prescription were established to ensure that the 
participant's healthcare professional has determined that the 
supplemental foods are not medically contraindicated by the 
participant's condition. Therefore, FNS retains the technical 
requirements for medical documentation for supplemental foods in Food 
Package III as written in the interim rule. However, FNS recognizes 
that WIC registered dietitians and/or qualified nutritionists play an 
important role in the continuum of care of medically fragile WIC 
participants. Therefore, FNS would support State agency policy that 
allows health care providers to refer to the WIC registered dietitian 
and/or qualified nutritionist for identifying appropriate supplemental 
foods (excluding WIC formula) and their prescribed amounts, as well as 
the length of time the supplemental foods are required by the 
participant. This arrangement would be supported only in situations 
where the health care provider has indicated on the medical 
documentation form that the provider acknowledges referral to the WIC 
registered dietitian and/or qualified nutritionist for such 
determinations. This gives the health care provider medical oversight 
while allowing the WIC registered dietitian and/or qualified 
nutritionist to determine the appropriate issuance of WIC foods to 
participants with qualifying conditions in Food Package III.
4. Sodium Content of WIC Foods
    In its Report, the IOM found that intakes of sodium were excessive 
in the

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diets of WIC participants. The IOM reported that more than 90 percent 
of WIC children 2 through 4 years and of pregnant, lactating, and non-
breastfeeding postpartum women had usual sodium intakes above the 
Tolerable Upper Intake Level (UL). More than 60 percent of WIC children 
age 1 year had usual sodium intakes above the UL. As such, the IOM 
recommended, and the interim rule reflected, reductions in the overall 
sodium level of WIC food packages. The majority of WIC foods under the 
interim rule may not contain added salt (sodium).
    However, options for some WIC foods, i.e., cheese, vegetable juice, 
canned vegetables, canned beans, peanut butter, and canned fish include 
both regular and lower sodium varieties. In an effort to support 
participants in reducing sodium intake, FNS provided technical 
assistance to State agencies encouraging them to offer only lower 
sodium varieties of these foods when these options exist.
    FNS encourages WIC State agencies that offer canned vegetables to 
allow only lower sodium canned vegetables and lower-sodium versions of 
other WIC-eligible foods, i.e., breads, as they become more widely 
available in the marketplace. FNS encourages food manufacturers to 
reduce excess sodium in processed foods and to make a wider variety of 
these foods available to help WIC achieve its goal to safeguard the 
health of children and women.
5. Organic Foods
    The interim rule authorizes 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 specific brands and types of foods to authorize on 
their State WIC food lists. Some State agencies 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.
    FNS received 52 comments asking that State agencies be required to 
offer organic foods in the WIC food packages. Many of these comments 
were from one State where the WIC State agency had recently removed 
organic milk from its list of authorized WIC foods. This final rule 
continues to provide State agencies the option to offer organic forms 
of WIC-eligible foods through the regular WIC food instrument, e.g., 
milk, eggs, peanut butter, and encourages State agencies to make 
available authorized foods that are acceptable and will be consumed by 
participants, including organic varieties. This final rule clarifies in 
Table 4 of 7 CFR 246.10(e)(12) that State agencies are required to 
allow organic forms of fruits and vegetables purchased with the cash-
value voucher.

C. Supplemental Foods and Food Packages

    Note:  The order of some of the topics in this section is 
modified from the interim rule for the purposes of discussion.

1. Fruits and Vegetables in Food Packages III Through VII
a. Dollar Amount of Cash-Value Voucher
    In order to maintain cost neutrality, the interim rule published 
December 2007 (72 FR 68966) only provided fully breastfeeding women 
with the IOM recommended amount of $10.00 per month fruit and vegetable 
cash-value vouchers; all other women participants were provided $8.00 
per month, and children were provided $6.00. An amendment to the 
interim rule was published in the Federal Register on December 31, 2009 
(74 FR 69243) to provide all WIC women participants with $10.00 per 
month fruit and vegetable cash-value vouchers, consistent with IOM's 
recommendations.
    A total of 448 commenters (76 form letters) asked FNS to increase 
the fruit and vegetable cash-value voucher to the IOM recommended level 
from $6 to $8 for children. The Department has responded to commenters' 
requests under this final rule by increasing the cash-value voucher for 
children to $8 per month. This increase will allow State agencies to 
further efforts to increase fruit and vegetable consumption by 
children.
    A total of 162 commenters (36 form letters) asked FNS to further 
increase the fruit and vegetable voucher for fully breastfeeding women 
from $10 to $12 to provide incentive for women to choose to fully 
breastfeed, and to meet the intent of the IOM to provide an enhancement 
to the food packages for fully breastfeeding women. While FNS 
understands the benefit of increasing the value of the food package for 
fully breastfeeding women, it is not possible under this rulemaking to 
go beyond the dollar value for the cash-value voucher for the fully 
breastfeeding package due to cost. Therefore, the cash-value voucher 
remains at $10 for all women, including fully breastfeeding women, in 
this final rule. The base year for calculation of the value of the 
fruit and vegetable voucher and the base value to be used are updated 
in 7 CFR 246.16(j)(2).
b. Clarification of Authorized Fruits and Vegetables
    To improve the consumption of fresh fruits and vegetables and to 
appeal to participants of different cultural backgrounds, the interim 
rule authorized a wide variety of choices within the authorized fruit 
and vegetable options. The interim rule reflects the IOM recommendation 
to provide a cash-value fruit and vegetable benefit to participants 
with few restrictions. The following is a discussion of clarifications 
and revisions to the interim rule pertaining to authorized fruits and 
vegetables. Technical corrections in this final rule clarify that both 
fresh fruits and fresh vegetables must be authorized by State agencies. 
This final rule further clarifies that 21 CFR 101.95 defines the term 
``fresh'' when referring to eligible fresh fruits and vegetables.
    Technical corrections in this final rule clarify that the cash-
value voucher may be redeemed for any eligible fruit and vegetable 
(refer to Table 4 of 7 CFR 246.10(e)(12) and its footnotes). Except as 
authorized by this final rule, State agencies may not selectively 
choose which fruits and vegetables are available to participants. For 
example, if a State agency chooses to offer dried fruits, it must 
authorize all WIC-eligible dried fruits, i.e., those without added 
sugars, fats, oils, or sodium, and may not allow only a single variety 
of dried fruits. This final rule clarifies that State agencies may, 
however, invoke their administrative option at 7 CFR 246.10(b)(1)(i) to 
establish criteria in addition to the minimum Federal requirements in 
Table 4 of 7 CFR 246.10(e)(12), which could include restricting 
packaging (such as plastic containers) and package sizes (such as 
single serving) of processed fruits and vegetables available for 
purchase with the cash-value voucher. In addition, State agencies may 
identify specific types of certain processed WIC-eligible fruits and 
vegetables (e.g., salsas, tomato sauces, stewed and diced tomatoes) on 
their food lists if they believe there is cause for significant vendor 
and participant confusion in identifying specific items within those 
categories that are WIC-eligible.
    A technical correction has been made in Table 4 of 7 CFR 
246.10(e)(12) to clarify that the following products are not allowed: 
Dried white potatoes, mixed vegetables containing white potatoes, 
noodles, nuts or sauce packets, and decorative flowers and blossoms. 
Canned tomato sauce and tomato paste without added sugar, fats, oils 
are authorized. Salsa and spaghetti sauce

[[Page 12278]]

without added sugar, fats, and oils are also authorized.
    This final rule clarifies that the fruit or vegetable must be 
listed as the first ingredient in WIC-eligible processed fruits and 
vegetables. In addition, it clarifies that frozen fruits may not 
contain added fats, oils, salt (i.e., sodium) or added sugars.
    For the reasons described in section IV.B.4 of this preamble, Table 
4 of 7 CFR 246.10(e)(12) will be revised to allow State agencies the 
option to offer only lower sodium canned vegetables for purchase with 
the cash-value voucher.
c. White Potatoes
    The interim rule excludes the purchase of white potatoes with the 
cash-value voucher. A total of 266 (of these, 213 were form letters) 
opposed the restriction of white potatoes. Commenters stated that white 
potatoes should be included in the WIC food packages because they are 
versatile, economical, contain key nutrients, and are preferred by 
participants. Thirty-two commenters (20 form letters) stated that the 
exclusion of white potatoes is difficult to administer.
    The restriction of white potatoes, as recommended by the IOM, is 
based on data indicating that consumption of starchy vegetables meets 
or exceeds recommended amounts, and food intake data showing that white 
potatoes are the most widely used vegetable. Including white potatoes 
in the WIC food packages would not contribute towards meeting the 
nutritional needs of the WIC population and would not support the goal 
of expanding the types and varieties of fruits and vegetables available 
to program participants, as recommended by the IOM. Therefore, the 
provision to exclude white potatoes from the WIC food packages is 
retained in this final rule. The Department recognizes that white 
potatoes can be a healthful part of one's diet. However, WIC food 
packages are carefully designed to address the supplemental nutritional 
needs of a specific population. Although white potatoes are not offered 
in the WIC food package, nutrition education provided to WIC 
participants will continue to include white potatoes as a healthy 
source of nutrients and an important part of a healthful diet.
d. Dried Fruit and Dried Vegetables for Children
    As recommended by the IOM, the interim rule disallows dried fruits 
and vegetables to be purchased with the cash-value voucher for children 
because of the risk of choking. FNS received a small number of comments 
asking that dried fruits be allowed for children, citing a lack of 
evidence that they pose choking hazards for all children. 
Recommendations made by IOM for the Child and Adult Care Food Program 
allow dried fruits for children as long as they do not pose a choking 
hazard.\2\ Therefore, at the State agency's option, this final rule 
authorizes dried fruits and dried vegetables to be purchased with the 
cash-value voucher for children. Nutrition education regarding choking 
hazards, developmental readiness, proper food preparation, and oral 
health care should be provided to caregivers of young children.
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    \2\ Institute of Medicine, National Academy of Sciences. ``Child 
and Adult Care Food Program: Aligning Dietary Guidance for All,'' 
2010. Available at Internet site: http://www.fns.usda.gov/child-and-adult-care-food-program-aligning-dietary-guidance-all.
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e. Standards of Identity for Canned Fruits and Canned Vegetables
    Two technical corrections have been in made in Table 4 of 7 CFR 
246.10(e)(12) related to the standards of identity for canned fruits 
and canned vegetables. This final rule corrects the specifications for 
WIC-eligible canned fruits to reflect that only those WIC-eligible 
canned fruits that have a standard of identity, as listed at 21 CFR 
Part 145, must conform to the FDA standard of identity. Similarly, this 
final rule corrects the specifications for WIC-eligible canned 
vegetables to reflect that only those WIC-eligible canned vegetables 
that have a standard of identity, as listed at 21 CFR Part 155, must 
conform to the FDA standard of identity. The provision that WIC-
eligible canned vegetables contain no added sugars, fats, and oils 
remains unchanged. This final rule clarifies that home-canned and home-
preserved fruits and vegetables are not authorized.
f. Implementation of Fruit and Vegetable Options
    (1) Paying the difference with the cash-value voucher. The interim 
rule authorized State agencies the option to allow participants to pay 
the difference if the fruit and vegetable purchase exceeds the value of 
the cash-value voucher, a transaction known as ``split tender.'' A 
total of 116 commenters (59 form letters) asked FNS to require all 
State agencies to allow split tender transactions to ensure that 
participants are able to maximize use of their cash-value voucher. 
Because it may be difficult for participants to accurately estimate the 
exact purchase price of the fruit and vegetable selections, 
particularly when fresh, canned, dried, or frozen items are combined in 
one purchase or when items are purchased in bulk, FNS agrees that all 
participants should be allowed to pay the difference when the purchase 
of allowable fruits and vegetables exceeds the value of the fruit/
vegetable cash-value voucher. Therefore, this final rule adds a 
provision at 7 CFR 246.12(f)(4) to require State agencies to allow 
split tender transactions with the cash-value voucher.
    (2) Minimum vendor stocking requirements. A technical oversight in 
the interim rule has been corrected at 7 CFR 246.12(g)(3)(i) by 
clarifying that authorized vendors must stock at least two different 
fruits and two different vegetables.
    (3) Authorizing farmers' markets. The interim rule gave State 
agencies the option to allow farmers at farmers' markets to accept 
cash-value vouchers. FNS received 29 comments (mostly form letters) 
recommending that farmers' market organizations, rather than the 
individual farmer, be authorized to accept cash-value vouchers, as is 
permitted under the WIC Farmers' Market Nutrition Program (FMNP). 
Sixty-nine commenters (mostly form letters) additionally recommended 
that the WIC Program regulations be more closely aligned with the FMNP. 
Commenters stated that consistency between the two programs would make 
FMNP participation easier both for WIC participants and authorized 
farmers. Many of the comments suggested that State agencies be allowed 
to authorize farmers' markets in addition to the current provision (7 
CFR 246.12(v)) that allows State agencies the flexibility to authorize 
farmers at farmers' markets or roadside stands. FNS finds merit in such 
a provision; this also would provide more consistency between WIC and 
FMNP.
    Seventy-eight comments went on to suggest that the authorization of 
farmers' markets should be a Federal requirement, rather than a State 
agency option. FNS believes that State agencies are in the best 
position to determine what works for their individual benefit delivery 
systems, taking into consideration such factors as participant access, 
the availability of farmers, and the administrative burdens of 
monitoring and authorization. Therefore, the final rule amends 7 CFR 
246.12 to allow WIC State agencies to authorize farmers or farmers' 
markets to accept WIC cash-value vouchers, but such authorization will 
remain as a State agency option. As a result of the addition of 
farmers' markets, conforming amendments have been

[[Page 12279]]

made in 7 CFR 246.2, 246.4, 246.18, and 246.23.
    A number of comments were received recommending that the Federal 
WIC regulations be modified to be consistent with the fruits and 
vegetables eligible for purchase under the FMNP. FNS makes every effort 
to ensure that both programs are aligned in most areas, to the extent 
possible. However, each program has different statutory objectives. 
Thus, FNS is convinced that it is critical for each program to maintain 
its separate identity. As stated previously, FNS found merit in 
allowing farmers' markets to redeem WIC cash-value vouchers, an example 
of aligning both programs. FNS finds no need to make any further 
operational changes in this area through this final rule. A technical 
amendment is added to 7 CFR 246.4(a)(14) to correct a cross-reference 
to 7 CFR 246.12 that addresses the State agency options regarding 
vendor sanctions.
2. Mature Legumes (Dry Beans, Peas and Lentils) and Peanut Butter
a. Clarification of Allowable Mature Legumes
    Technical corrections have been made to the list of authorized 
mature legumes in Table 4 of 7 CFR 246.10(e)(12). Refried beans, 
without added sugars, fats, oils, vegetables or meat, have been added 
to the examples of allowable legumes in Table 4 of 7 CFR 246.10(e)(12). 
The specification in Table 4 also clarifies that mature legumes issued 
via the WIC food instrument may not contain added vegetables or fruits.
b. Issuance of Mature Legumes (Dry Beans and Peas)
    The interim rule includes mature dry beans, peas, or lentils in 
dry-packaged or canned forms as a WIC food category. Items in this food 
category are issued via the regular WIC food instrument. FNS provided 
technical assistance to State agencies on the interim rule clarifying 
that beans and peas that do not qualify under this category may be 
purchased only with the cash-value voucher. A total of 23 commenters (8 
of which were form letters) asked FNS to allow all mature varieties and 
forms of dry beans and peas to be purchased with both the cash-value 
voucher and the WIC food instrument to eliminate confusion on the part 
of participants and vendors.
    The nutritional profile of mature dry legumes is different than 
that for immature varieties and FNS believes it is important to 
maintain this distinction. Mature legumes are excellent sources of 
plant protein, and also provide other nutrients such as iron and zinc. 
Mature dry beans and peas are similar to meats, poultry, and fish in 
their contribution of these nutrients. In WIC, they are offered as a 
separate food category from the fruit and vegetable category. 
Therefore, mature legumes in dry-packaged and canned forms, without 
added vegetables, fruits, meat, sugars, fats, or oils, are the only dry 
beans and peas authorized to be issued via the WIC food instrument.
c. Disallowed Ingredients in Peanut Butter
    A technical oversight has been corrected in Table 4 of 7 CFR 
246.10(e)(12) to disallow peanut butter with added marshmallows, honey, 
jelly, chocolate/or similar ingredients.
3. Fruit and Vegetable Juice
    Technical corrections have been made in Table 4 of 7 CFR 
246.10(e)(12) related to the standard of identities for canned fruit 
and vegetable juices. This final rule corrects the specifications for 
WIC-eligible canned fruit juice and vegetable juice to reflect that 
only those WIC-eligible juices that have a standard of identity, as 
listed at 21 CFR Part 146 and 21 CFR Part 156, must conform to these 
FDA standards of identity.
4. Milk and Milk Alternatives
    a. Whole milk for participants greater than 2 years of age. Under 
the interim rule, and as recommended by the IOM, whole milk is not 
authorized for children greater than 2 years of age and women in Food 
Packages IV-VII. Under the interim rule, whole milk may be issued to 
medically fragile children older than 2 years of age and women only in 
Food Package III for participants with qualifying conditions. A total 
of 216 commenters, primarily local agency WIC staff, asked FNS to allow 
the CPA to prescribe whole milk for participants in any food package if 
necessary for participants who have medical or nutritional reasons for 
requiring additional calories.
    FNS believes that WIC staff can assist participants in Food 
Packages IV-VII in meeting their nutritional needs through fat-reduced 
milks and other foods. Whole milk adds unnecessary saturated fat and 
cholesterol to the diets of 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. 
Therefore, the provision to authorize whole milk for children greater 
than 2 years of age and women only in Food Package III is retained in 
this final rule in Table 3 of 7 CFR 246.10(e)(11).
b. Fat-Reduced Milks for Children 12 Months to 2 Years of Age in Food 
Package III and IV
    Under the interim rule, children 12 months to 2 years of age may 
only be issued whole milk. A total of 332 commenters (34 form letters) 
want flexibility in this provision, citing American Academy of 
Pediatrics (AAP) policy,\3\ recommending fat-reduced milks for children 
over the age of 1 for whom overweight or obesity is a concern.
---------------------------------------------------------------------------

    \3\ American Academy of Pediatrics. Policy Statement Lipid 
Screening and Cardiovascular Health in Childhood, Pediatrics Vol. 
122 No. 1 July 2008, pp. 198-208.
---------------------------------------------------------------------------

    In light of current AAP policy, FNS will allow, at State agency 
option, fat-reduced milks to be issued to 1-year-old children (12 
months to 2 years of age) for whom overweight or obesity is a concern. 
Under Food Package IV, FNS will allow the CPA to make a determination 
for the need for fat-reduced milks for young children based on an 
individual nutritional assessment and consultation with the child's 
health care provider if necessary, as established by State agency 
policy. FNS will provide technical assistance for issuing fat-reduced 
milks to children 12 months to 2 years of age in Food Package IV. Due 
to the medically fragile qualifying conditions of children 12 months to 
2 years of age, FNS will continue to require medical documentation for 
issuance of WIC-eligible formula and foods, including fat-reduced 
milks, under Food Package III.
c. Fat Content of Milk for Children Over 2 Years of Age and Women
    Under the interim rule, children >= 24 months of age and women may 
be issued a variety of milk types (i.e., nonfat, lowfat (1%) and 
reduced fat (2%) milk). Seven commenters recommended the issuance of 
only nonfat or lowfat (1%) milk to children >= 24 months of age and 
women to be consistent with the Dietary Guidelines for Americans. FNS 
notes that State agencies already have policies to ensure that CPAs 
issue the appropriate milk to participants based on the assessed 
nutritional needs of individual participants. Since 1995 the Dietary 
Guidelines for Americans have recommended consumption of nonfat and 
lowfat milk and milk products. In technical assistance provided to 
State agencies on the interim rule, FNS supported and encouraged State 
agencies to issue only nonfat and lowfat

[[Page 12280]]

milk to children and women unless otherwise indicated by nutrition 
assessment. As such, FNS finds merit in adding a provision that nonfat 
and lowfat (1%) milks are the standard issuance for children >= 24 
months of age and women in Food Packages IV-VII. Reduced fat (2%) milk 
is authorized only for participants with certain conditions, including 
but not limited to, underweight and maternal weight loss during 
pregnancy. The need for reduced fat (2%) milk for children >= 24 months 
of age (Food Package IV) and women (Food Packages V, VI, VII) will be 
determined as part of the careful nutrition assessment completed by the 
CPA, as established by State agency policy.
d. Fortification of Whole Milk
    This final rule clarifies the minimum nutrient requirements for all 
milks listed in Table 4 of 7 CFR 246.10(e)(12). The table restates the 
milk specifications to make it clearer that vitamin A fortification is 
not required for whole milk.
e. Provision of Maximum Monthly Allowance of Milk
    Under the interim rule, the maximum monthly allowance of milk must 
be provided to participants, as the WIC benefit to participants is the 
full authorized amount. The interim rule allows a substitution rate of 
1 pound of cheese for 3 quarts of milk, leaving a quart of milk or milk 
substitute that must be provided to participants issued this option to 
fulfill the maximum allowance in the food package.
    A total of 17 commenters (6 of these form letters) asked FNS to 
drop the ``dangling quart'' or allow State agencies to round the 
quantity of milk up when substituting cheese for milk because of 
limited availability and higher costs of milk in quart size containers. 
A total of 20 commenters (6 of these form letters) asked FNS to allow 
State agencies to issue 12 ounce cans of evaporated milk, which are the 
largest size available in the marketplace and which reconstitute to 24 
fluid ounces, as the ``dangling quart.''
    The IOM cited milk as an important source of calcium and vitamin D 
for WIC participants, and this food category should not be 
shortchanged. Therefore, the ``dangling quart'' may not be ignored. 
This final rule will continue to require that State agencies provide 
the maximum allowance of milk to participants if cheese is substituted 
for milk in order for participants to obtain their full milk benefit.
    State agencies continue to have the option to make available other 
authorized milk substitutes to fulfill the maximum allowance. Because 
milk in quart sizes has become more widely available as States have 
implemented the interim rule, and this final rule allows the option of 
providing a quart of yogurt for children and women (as described in a 
subsequent section of this preamble), and allows issuance of a 12 ounce 
can of evaporated milk to substitute for the ``dangling quart,'' State 
agency concerns about difficulty providing the full milk benefit to 
participants who substitute cheese for milk should be alleviated. State 
agencies also have the option to prescribe half gallon containers of 
milk every other month for participants in lieu of the ``dangling 
quart.''
f. Cheese in Excess of Maximum Substitution Rates
    Under the interim rule, cheese may be substituted for milk. The IOM 
set a substitution rate for cheese for milk, but put a cap on the 
amount that can be substituted to control total and saturated fat 
content of the food packages. Under the interim rule, FNS allowed, with 
medical documentation, additional amounts of cheese to be issued beyond 
the substitution rate to provide State agencies with flexibility to 
accommodate participants with lactose intolerance. This accommodation 
was made because, at the time, milk alternatives for participants with 
lactose intolerance were more limited. Few soy-based beverages that met 
FNS' nutritional standards were available, and the interim rule did not 
authorize yogurt, which had been recommended by IOM as a milk 
substitute. Since that time, more soy-based beverages that meet the 
nutritional standards established by FNS are available in the 
marketplace, and this final rule authorizes yogurt for children and 
women. As a result, State agencies have increased flexibility, in 
addition to offering lower lactose milks, to accommodate lactose 
intolerance with substitutes other than cheese, as recommended by the 
IOM. Therefore, this final rule will no longer allow cheese to be 
issued beyond established substitution rates, even with medical 
documentation, which is consistent with the recommendation of the IOM.
g. Yogurt
    The IOM recommended adding yogurt to the WIC food packages as a 
partial milk substitute for children and women. However, under the 
interim rule, FNS determined that the addition of yogurt to the WIC 
food packages was cost prohibitive. The interim rule solicited comments 
from State agencies about the extent to which WIC participants would 
benefit from the addition of yogurt, and whether that addition could be 
achieved in a cost-effective manner.
    A total of 304 comment letters (63 of these form letters) 
encouraged FNS to allow yogurt as a milk substitute, emphasizing that 
yogurt provides priority nutrients and is convenient, popular, and 
culturally acceptable to WIC participants. Commenters also cited a 
pilot study, conducted by the California WIC Program in conjunction 
with the National Dairy Council, which demonstrated the feasibility of 
providing yogurt in WIC food packages.\4\ The pilot study results cited 
participant acceptance and ease of implementation.
---------------------------------------------------------------------------

    \4\ Fung, EB, et al. Randomized, controlled trial to examine the 
impact of providing yogurt to women enrolled in WIC. J Nutr Educ 
Behav. 2010 May-Jun;42(3 Suppl):S22-9.
---------------------------------------------------------------------------

    FNS agrees that yogurt is a desirable milk alternative for 
participants who might not otherwise drink sufficient amounts of fluid 
milk due to lactose intolerance or other reasons. Therefore, this final 
rule authorizes yogurt as a substitute for milk for children and women 
in Food Packages III-VII, at the State agency's option.
(1) Maximum Monthly Allowance of Yogurt
    At State agency option, 1 quart of yogurt may be substituted for 1 
quart of milk for women and children in Food Packages III-VII. No more 
than 1 quart of yogurt is authorized per participant.
(2) Authorized Yogurts
    As recommended by the IOM, yogurt must conform to the standard of 
identity for yogurt as listed in Table 4 of 7 CFR 246.10(e)(12) and may 
be plain or flavored with <= 40 grams of total sugar per 1 cup of 
yogurt. Only lowfat and nonfat yogurts are authorized for children over 
2 years of age and women. Whole fat yogurt is authorized only for 
children less than two years of age. State agencies have the option to 
determine the container sizes of yogurt to authorize on their food 
lists.
h. Tofu
    Under the interim rule, calcium-set tofu prepared only with calcium 
salts, (e.g., calcium sulfate), and without added fats, sugars, oils, 
or sodium, is authorized. A technical correction has been made in this 
final rule to clarify that tofu must be calcium-set, i.e., contain 
calcium salts, but may also contain other coagulants, i.e., magnesium 
chloride. This additional flexibility allows State agencies to meet the 
needs of WIC's culturally diverse participants. Tofu with only calcium

[[Page 12281]]

sulfate may not be readily available in the marketplace. Major tofu 
manufactures with national distribution make tofu with calcium sulfate 
alone or in addition to magnesium chloride as a coagulant. Magnesium 
chloride is not a flavoring or preservative, and should not be confused 
with sodium chloride, which is not permitted. The calcium content of 
various types of tofu, even those set only with calcium salts, varies. 
In choosing the brands and types of calcium-set tofu to include on food 
lists, State agencies should read the nutrition labels and choose tofu 
with the highest amount of calcium.
5. Breastfeeding Provisions
    Under the interim rule, food packages for infants and women are 
designed to strengthen WIC's breastfeeding promotion and support 
efforts and provide additional incentives to assist mothers in making 
the decisions to initiate and continue to breastfeed. The provisions 
disallow routine issuance of infant formula to partially breastfeeding 
infants in the first month after birth to help mothers establish milk 
production and the breastfeeding relationship. Overall, commenters 
expressed support for the breastfeeding provisions, with 7 State 
agencies stating they have already seen increases in breastfeeding 
rates attributable to the interim rule provisions. State agencies 
stressed that adequate training of WIC staff and the provision of 
appropriate counseling and support to mothers is critical to the 
success of the new food packages for the breastfeeding mothers and 
their infants.
a. Exclusive Breastfeeding
    This final rule clarifies the intent of the WIC Program that all 
women be supported to exclusively breastfeed their infants and to 
choose the fully breastfeeding food package without infant formula at 7 
CFR 246.10(e). Breastfeeding women who do not exclusively breastfeed 
are to be supported to continue breastfeeding to the maximum extent 
possible through minimum supplementation with infant formula.
b. Clarification of Partially Breastfeeding Terminology
    Commenters asked FNS to address terminology used to describe the 
mother-infant pair who ``partially'' breastfeed (both breastfeed and 
formula feed). Confusion exists because partially breastfeeding is used 
to describe a combination of any amounts of breastfeeding and formula 
feeding. However, under the interim rule, for the purposes of food 
package issuance, the partially breastfeeding food package is defined 
by a maximum quantity of formula that assumes the mother is 
substantially breastfeeding her infant. Confusion also exists because 
WIC's definition of a breastfeeding woman is the practice of feeding a 
mother's breast milk to her infant on the average of at least once a 
day. This definition determines the categorical eligibility of a 
participant as a breastfeeding woman, and did not change under the 
interim rule revising the WIC food packages. All women who meet this 
definition are counted as breastfeeding women for participation 
purposes, regardless of the food package they are issued or the amount 
of formula their infants receive.
    Under the interim rule, three infant feeding variations are defined 
for the purposes of assigning food quantities and types in Food 
Packages I and II for infants: (1) Fully formula feeding, (2) fully 
breastfeeding (the infant does not receive formula from the WIC 
Program), and (3) partially breastfeeding (the infant is breastfed but 
also receives some infant formula from WIC up to the maximum allowance 
described for partially breastfed infants in Table 1 of 7 CFR 
246.10(e)(9)). Breastfeeding assessment and the mother's plans for 
breastfeeding serve as the basis for determining food package issuance. 
Breastfed infants who are assessed to need more formula than is allowed 
under the food package for partially breastfed infants are assigned to 
the fully formula feeding package.
    FNS agrees that terminology used to describe food packages for the 
mother-infant pair that both breastfeed and formula feed, regardless of 
amount from either source, needs clarification. Therefore, this final 
rule attempts to minimize confusion about food package issuance by 
parenthetically adding the descriptor ``mostly'' breastfeeding to the 
partially breastfeeding food package designation established under the 
interim rule.
c. Issuance of Formula to Breastfed Infants
    There has been some confusion about the issuance of one can of 
powder infant formula in the first month to breastfed infants. For 
breastfeeding women who do not receive the fully breastfeeding package, 
WIC staff are expected to individually tailor the amount of infant 
formula based on the assessed needs of the breastfeeding infant and 
provide the minimal amount of formula that meets but does not exceed 
the infant's nutritional needs. This is consistent with long-standing 
FNS policy that dates back to the 1980s. State agencies should develop 
policies for handling breastfeeding mothers' formula requests that 
encourage substantial and continued breastfeeding. This is true whether 
the infant receives the fully formula feeding package (although the 
infant may be minimally breastfeeding) or the partially (mostly) 
breastfeeding food package. The full nutrition benefit should not be 
used as the standard for issuance unless the mother is not 
breastfeeding the infant at all.
    The interim rule strengthened the WIC food packages to better 
enhance breastfeeding promotion and support. Food packages for 
partially (mostly) breastfed infants and women were created that 
provide additional foods for mothers as incentives, to better meet 
nutritional needs, and to provide less infant formula to partially 
breastfed infants than to infants who receive the fully formula fed 
package.
    The food packages for partially (mostly) breastfed mothers and 
infants are designed to provide for the supplemental nutrition needs of 
the breastfeeding pair, provide minimal formula supplementation to help 
mothers maintain milk production, and provide incentives for continued 
breastfeeding by way of a larger variety and quantity of food than the 
full formula/postpartum packages. FNS emphasizes that the benefits of 
the partially breastfed food packages are lost if the breastfeeding 
mother-infant pair is issued the full formula/postpartum packages. 
Appropriate support and counseling should be provided to mothers to 
minimize the number of breastfeeding infants receiving the full formula 
packages.
    This final rule clarifies at 7 CFR 246.10(b)(2)(ii)(C) that food 
package quantities are to be issued based on assessment of each 
participant's individual breastfeeding and nutritional needs.
d. Issuance of Formula to Breastfed Infants in the First Month After 
Birth
    This final rule clarifies that the issuance of any formula to 
breastfed infants in the first month after birth is a State agency 
option. If a State agency chooses this option, it may issue one can of 
powder infant formula in the container size that provides closest to 
104 reconstituted fluid ounces to partially breastfed infants on a 
case-by-case basis. Breastfed infants who are provided this option are 
considered partially (mostly) breastfed. Breastfed infants should not 
receive more than the one can option in order to maintain the mother's 
milk production. State agencies should not create food packages that 
standardize issuance of formula to partially (mostly) breastfed infants 
in the first month after birth.

[[Page 12282]]

e. Food Package VII for Fully Breastfeeding Women
    Under the interim rule, 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 (mostly) breastfeeding 
multiple infants. This final rule clarifies that Food Package VII is 
issued to partially (mostly) breastfeeding mothers who are 
breastfeeding multiples from the same pregnancy.
    A total of 12 commenters (4 form letters) asked that partially 
breastfeeding women who are also pregnant be allowed to receive the 
more enhanced Food Package VII. FNS agrees with commenters that 
pregnant women who are also partially (mostly) breastfeeding singleton 
infants would benefit from the increased quantity and variety of foods 
in this food package. Therefore, this final rule authorizes pregnant 
women who are also partially (mostly) breastfeeding to receive Food 
Package VII.
    Under the interim rule, women fully breastfeeding multiples receive 
1.5 times the maximum allowance of foods authorized in Food Package VII 
to meet their nutritional needs. A total of 36 commenters (8 form 
letters) asked FNS to revise the food package quantities for women 
fully breastfeeding multiples to reflect a consistent amount each month 
and to specify amounts in quantities available in marketplace. In 
technical assistance provided to State agencies on the interim rule, 
FNS provided flexibility to allow States to choose how they will issue 
these quantities. Some States have elected to issue foods in this food 
package in amounts averaged over a 2-month timeframe to eliminate 
concern about providing quantities available in the marketplace. Others 
issue double the ``regular'' fully breastfeeding package one month and 
then issue the ``regular'' fully breastfeeding package the next month. 
FNS will allow State agencies to retain the flexibility to determine 
how best to issue food packages quantities for women fully 
breastfeeding multiples and therefore will not change the provision to 
specify a set amount that must be provided each month.
f. Human Milk Fortifier (HMF)
    Fifteen commenters (4 form letters) asked that partially (mostly) 
breastfeeding women whose infants receive human milk fortifier (HMF) be 
considered fully breastfeeding.
    Issuance of HMF as a WIC formula is allowed with medical 
documentation under the interim rule, as it was under previous WIC 
policy. A woman whose infant receives HMF is considered partially 
breastfeeding because her infant is receiving formula from WIC. HMF 
provides additional protein, minerals, and vitamins that, when added to 
breastmilk in the first postpartum month for premature infants, results 
in nutrient, mineral, and vitamin concentrations similar to those of 
the formulas developed for feeding preterm infants. HMF is given in the 
hospital, but most often is discontinued prior to discharge. There is a 
limit on how long HMF is necessary and the need and length of time an 
infant should remain on HMF should be determined and monitored by the 
health care provider.
    Since HMF is to be used for only a very short time, the woman can 
be transitioned back to the fully breastfeeding package as soon as the 
infant is no longer receiving HMF from WIC. The final rule will retain 
the provision that Food Package VII is issued only to women whose 
infants do not receive formula from WIC, including HMF.
6. Whole Wheat Bread and Whole Grain Options
a. Authorized Breads
    Under the interim rule, whole wheat breads, rolls and buns that 
meet the FDA standard of identity for whole wheat bread (21 CFR 
136.180) are authorized. Some commenters asked FNS to allow baked 
products that do not meet the standard of identity for whole wheat 
bread, e.g., English muffins and bagels, if these products otherwise 
meet the whole wheat requirements. FNS has considered this request, but 
has determined that identifying the WIC-eligibility of whole wheat 
bread products that do not meet the standard of identity would be 
complex given the number of products in the marketplace. Therefore, the 
requirement that whole wheat breads meet the standard of identity for 
whole wheat bread is retained in this final rule in Table 4 of 7 CFR 
246.10(e)(12).
b. Package Sizes of Whole Wheat/Whole Grain Bread
    The interim rule established a maximum monthly allowance of two 
pounds of whole wheat bread or other whole grain options for children 
in Food Packages III and IV; and one pound of whole wheat bread or 
other whole grain options for women in Food Packages III, V and VII. 
Commenters asked that FNS authorize bread in the more commonly 
available 20 ounce package size.
    Although the availability of bread in package sizes to meet the WIC 
maximum monthly amount of bread authorized in WIC food packages was of 
initial concern as State agencies planned to implement the new food 
packages and supply in the marketplace may have been limited, bread 
manufacturers have increasingly produced WIC-eligible breads in 16 
ounce package sizes to respond to the changes in the WIC Program. As 
such, all State agencies have breads in appropriate size packages on 
their WIC food lists. A greater number of WIC-eligible breads in 16 
ounce package sizes continue to be introduced by manufacturers, which 
will further increase the bread options available to participants. 
Therefore, FNS believes that this situation has been addressed and the 
maximum allowance for whole wheat and whole grain bread is unchanged in 
this final rule.
c. Expansion of Whole Grain Options
    Under the interim rule, whole grains (brown rice, bulgur, oats, and 
whole grain barley), as well as tortillas, are authorized as 
substitutions for whole wheat and whole grain bread. A total of 310 
commenters (22 of these form letters) asked FNS to consider expanding 
the list of whole grain foods available to participants. Suggestions 
included whole grain pasta, whole wheat English Muffins, and whole 
wheat bagels.
    To make available additional whole grain foods to participants, 
this final rule will add whole wheat pasta to the list of whole wheat/
whole grain bread alternatives. Whole wheat macaroni (pasta) products 
that meet the FDA standard of identity (21 CFR 139.138) and have no 
added sugars, fats, oils, or salt (i.e., sodium) are WIC-eligible. 
Other shapes and sizes that otherwise meet the FDA standard of identity 
for whole wheat macaroni (pasta) products are also authorized (e.g. 
whole wheat rotini, whole wheat penne).
d. Technical Corrections
    In technical assistance provided to State agencies on the interim 
rule, FNS clarified that State agencies must offer whole wheat and/or 
whole grain bread. State agencies have the option to also authorize the 
other whole grain options listed in Table 4 of 7 CFR 246.10(e)(12). 
This final rule clarifies this provision. Also, consistent with 
technical assistance provided to State agencies on the interim rule, 
FNS clarifies in Table 4 of 7 CFR 246.10(e)(12) of this final

[[Page 12283]]

rule that corn tortillas made from ground masa flour (corn flour) using 
traditional processing methods are WIC-eligible. FNS recognizes that a 
small loss of corn kernel occurs during the traditional processing of 
tortillas, and therefore, such tortillas are not considered whole 
grain. FNS encourages State agencies to authorize corn tortillas that 
have whole corn listed as their primary ingredient. However, if the 
market availability of such corn tortillas is limited, FNS will allow 
State agencies to authorize corn tortillas made from ground masa flour 
using traditional processing methods, due to the high participant 
acceptance of corn tortillas, especially among Hispanic cultures. A 
technical clarification has been made in Table 4 of 7 CFR 246.10(e)(12) 
to the minimum requirements and specifications for whole wheat 
tortillas to address the types of flour authorized. This final rule 
continues to require that whole grain breads and cereals meet FDA 
labeling requirements for making a health claim as a ``whole grain food 
with moderate fat content.'' However, for simplicity and clarity, the 
final rule removes the specifics of the labeling requirements from 
Table 4 of 7 CFR 246.10(e)(12) and instead refers readers and 
manufacturers directly to the FDA health claim notification for further 
reference at http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073634.htm.
    A technical clarification has been made in Table 4 of 7 CFR 
246.10(e)(12) to the minimum requirements and specification for whole 
wheat bread to address consistency with the standard of identity for 
whole wheat bread. For additional clarity and to aid State agencies and 
participants in identifying WIC-eligible whole grain bread products, a 
statement has been added to the requirements noting whole grain breads 
must conform to the FDA standard of identity for bread, buns and rolls.
7. Breakfast Cereals
    Under the interim rule, at least one half of all breakfast cereals 
on each State agency's authorized food list must meet the whole grain 
requirements as specified in Table 4 at 7 CFR 246.10(e)(12). This 
provision allows certain corn and rice-based cereals to be offered to 
participants who may have allergies to whole grain cereals. FNS is 
retaining this provision in this final rule, but encourages State 
agencies to issue whole grain cereals to participants to the maximum 
extent possible, reserving non-whole grain options for those 
participants with allergies or other medical reasons where whole grains 
are contraindicated. Participants should receive nutrition education on 
the benefits of whole grain in the diets to reduce the risk of coronary 
heart disease and type-2 diabetes, help with body weight maintenance, 
and increase intake of dietary fiber.
    A technical correction has been made in this final rule in Table 4 
of 7 CFR 246.10(e)(12) to clarify that there is no FDA standard of 
identity listed for breakfast cereals.
8. Infant Foods in Food Packages II and III
a. Fresh Bananas as Substitute for Jarred Infant Foods
    Under the interim rule, State agencies have the option to offer 
fresh bananas as a substitute for up to 16 ounces of infant food fruit 
at a rate of one pound of bananas per eight ounces of infant food fruit 
via the regular WIC food instrument. To ensure participants receive the 
full food package benefit of this provision, and to simplify the 
transaction for vendors as well as participants, FNS will also allow 
State agencies the option to substitute fresh bananas at a rate of one 
banana per four ounces of jarred infant food fruit, up to a maximum of 
16 ounces, in Food Packages II and III for infants 6 to 12 months of 
age. This is consistent with recommendations of the IOM.
b. Cash-Value Voucher in Lieu of Commercial Jarred Infant Foods
    Under the interim rule, jarred infant foods (fruits, vegetables, 
and meat) are provided in Food Packages II and III for infants 6 months 
through 11 months of age. Although this provision overall has been well 
received, concerns initially made by commenters on the proposed rule 
persist regarding this provision. A total of 508 commenters on the 
interim rule asked FNS to include a State option to provide a cash-
value voucher to older infants receiving Food Packages II and III in 
lieu of commercial jarred infant food fruits and vegetables. Commenters 
stated that foods for older infants should be developmentally 
appropriate as infants transition to toddler foods, and noted the lack 
of availability of jarred infant foods in appropriate textures for the 
older infant. Commenters also stated that the amount of jarred infant 
foods in the WIC food packages is excessive for some older infants who 
are progressing in their feeding skills and transitioning from infant 
foods to table foods consumed during family meals.
    FNS remains committed to IOM's recommendation that commercial 
jarred infant foods be provided in the WIC food packages to ensure that 
infants receive and consume fruits and vegetables in developmentally 
appropriate textures and in a variety of flavors. The IOM also intended 
that commercial jarred infant foods be provided to ensure that these 
items are consumed by infants and not other participants or family 
members. Food safety and nutrient content were also considerations. FNS 
recognizes these considerations and continues to provide commercial 
jarred infant foods in this final rule.
    FNS acknowledges the preference for alternative options for infants 
and agrees that the lack of developmentally appropriate infant foods 
available in the marketplace may make it difficult for State agencies 
to provide a range of textures appropriate for infants at different 
stages of development. This void in the market is particularly noted 
among infant food products for older infants, and may compromise the 
appropriate progression of an infant's feeding skills. The FNS Infant 
Nutrition and Feeding Guide \5\ indicates that at around nine months of 
age, most infants are developmentally ready to consume foods of 
increased texture and consistency. Such consistency should progress 
from pureed to ground to fork-mashed and eventually to diced.
---------------------------------------------------------------------------

    \5\ Food and Nutrition Service 2009. Infant Nutrition and 
Feeding: A Guide for Use in the WIC and CSF Programs. Available at 
Internet site: http://www.nal.usda.gov/wicworks/Topics/FG/CompleteIFG.pdf.
---------------------------------------------------------------------------

    Therefore, in light of these considerations, under this final rule, 
FNS will allow infants 9 months through 11 months of age to receive a 
cash-value voucher for the purchase of fresh fruits and vegetables in 
lieu of a portion of the infant food fruits and vegetables provided in 
Food Packages II and III. For partially breastfed infants and fully 
formula fed infants, participants may opt to receive a $4 cash-value 
voucher plus 64 ounces of infant food fruits and vegetables; fully 
breastfed infants may receive an $8 cash-value voucher plus 128 ounces 
of infant food fruit and vegetables. The decision to issue cash-value 
vouchers in lieu of infant food fruits and vegetables is a State agency 
option. If a State agency chooses this option, it may not categorically 
issue cash-value vouchers to all infants of this age group. Instead, 
the cash-value voucher is to be provided to the participant only after 
a thorough assessment by the CPA, as established by State agency 
policy, and is optional for the participant, i.e., the mother may 
choose to receive either the maximum allowance of jarred foods or the 
combination of jarred foods and a fruit

[[Page 12284]]

and vegetable cash-value voucher for her infant. State agencies must 
ensure that appropriate nutrition education is provided to the 
caregiver addressing safe food preparation, storage techniques, and 
feeding practices to make certain participants are meeting their 
nutritional needs in a safe and effective manner.
    States continue to have the option to offer, via the regular WIC 
food instrument, fresh bananas as a substitute for infant food fruit in 
Food Packages II and III for infants six to twelve months of age as 
described in section IV.C.8.a of this preamble.
    This final rule clarifies that a fruit or vegetable must be listed 
as the primary (first) ingredient in WIC-eligible jarred infant foods. 
Further, this final rule clarifies that combinations of single 
ingredients of fruits and/or vegetables (e.g., peas and carrots, apples 
and squash) are allowed in Food Package II and III for infants 6 to 12 
months of age.
c. White Potatoes in Jarred Infant Foods
    White potatoes are excluded from purchase with the cash-value 
voucher in the WIC food packages. However, this final rule clarifies 
that jarred infant foods that meet the minimum requirements and 
specifications for an infant food product and include white potatoes as 
an ingredient, but not the primary ingredient, are allowed in Food 
Packages II and III for infants 6 to 12 months of age.
d. Infant Cereal
    Under the interim rule, infant cereal is provided in Food Packages 
II and III for infants 6 months to 12 months of age. A total of 223 
commenters (16 form letters) asked FNS to allow State agencies the 
option to offer ``adult'' breakfast cereals, as appropriate, to older 
infants to encourage developmental feeding skills and support the 
transition from infant foods to appropriate table and finger foods. 
Commenters stated that participants report not purchasing infant cereal 
because older infants prefer cereals they can eat with their fingers.
    The IOM recommended the provision of iron-fortified infant cereal 
for infants 6 to 12 months of age as a quality source of iron and zinc, 
nutrients needed by infants for optimal growth and development. 
Providing infant cereal for infants 6 months through 11 months of age 
is consistent with pediatric nutrition guidelines. The FNS Infant 
Nutrition and Feeding Guide \6\ states that ready-to-eat, iron-
fortified cereals designed for adults or older children are not 
recommended for infants because they: (1) often contain mixed grains; 
(2) tend to contain more sodium and sugar than infant cereals; and (3) 
typically contain less iron per infant-sized serving. Food safety is 
also of concern with the provision of adult cereals to infants as these 
products could cause choking if the infant is not developmentally ready 
to consume foods of this texture. For these reasons, the provision of 
iron-fortified infant cereal for infants 6 months of age through 12 
months of age in Food Packages II and III remains unchanged in this 
final rule.
---------------------------------------------------------------------------

    \6\ Food and Nutrition Service 2009. Infant Nutrition and 
Feeding: A Guide for Use in the WIC and CSF Programs. Available at 
Internet site: http://www.nal.usda.gov/wicworks/Topics/FG/CompleteIFG.pdf
---------------------------------------------------------------------------

9. Canned Fish
    The IOM recommended that a variety of canned fish that do not pose 
a mercury hazard be offered in Food Package VII. In addition to canned 
light tuna, canned salmon, and canned sardines, the interim rule 
authorized canned mackerel in Food Package VII for fully breastfeeding 
women. However, the two species of mackerel specified in the interim 
rule--N. Atlantic and Chub (Pacific)--are not readily available in 
canned form in the United States. FNS received 21 comments asking that 
canned Jack mackerel also be authorized in Food Package VII, citing its 
lower levels of mercury and acceptance by WIC participants.
    To allow more variety and choice among canned fish options, this 
final rule authorizes Jack mackerel as a canned fish option in Food 
Package VII. King mackerel is not authorized in any form. FNS 
encourages State agencies to offer all authorized canned fish options, 
i.e., tuna, salmon, sardines, and Jack mackerel, to ensure variety and 
choice for participants. This final rule also clarifies that canned 
fish with added sauces and flavorings, e.g., tomato sauce, mustard, 
lemon, are authorized at the State agency's option.
10. Food Package III for Children and Women With Qualifying Conditions
a. Infant Foods In Lieu of the Cash-Value Voucher
    Under the interim rule, children and women with qualifying 
conditions who require the use of a WIC formula (i.e., infant formula, 
exempt infant formula or WIC-eligible nutritional (formerly WIC-
eligible medical food)) receive Food Package III. Among the 
supplemental foods provided to participants in this food package is a 
cash-value voucher to purchase fruits and vegetables. A total of 33 
commenters requested the substitution of commercial jarred infant food 
fruit and vegetables in lieu of the cash-value voucher for participants 
over the age of one who have a qualifying medical condition, such as 
prematurity, developmental delays, and dysphasia (swallowing 
disorders). Commenters pointed out that these individuals would benefit 
from the use of this ready-to-feed form of pureed fruits and vegetables 
over the purchase of fresh fruits and vegetables.
    Food Package III is reserved for medically fragile participants who 
have specific dietary needs that are dictated by their medical 
condition. FNS is committed to providing these individuals with WIC 
Formula (i.e., infant formula, exempt infant formula and WIC-eligible 
nutritionals) and supplemental foods that best meet their special 
dietary needs. Thus, FNS finds merit in the argument that some 
participants with certain qualifying conditions may require a pureed 
form of fruits and vegetables to meet their nutritional needs, and 
would benefit from the convenience of purchasing jarred infant food 
fruits and vegetables. As such, this final rule allows State agencies 
the flexibility to provide children and women in Food Package III the 
option of receiving commercial jarred infant food fruits and vegetables 
in lieu of the cash-value voucher. The quantity of commercial jarred 
infant food fruits and vegetables is based on the substitution ratio of 
128 ounces of infant food fruits and vegetables for the $8 cash-value 
voucher for children and 160 ounces of infant food fruits and 
vegetables for the $10 cash-value voucher for women. The need for 
commercial jarred infant food fruits and vegetables in lieu of the 
cash-value voucher will be determined by medical documentation that 
meets the criteria established in 7 CFR 246.10(d). Some participants 
may prefer to purchase fruits and vegetables via the cash-value voucher 
and process/puree the fruits and vegetables themselves; this remains an 
option and is encouraged for those who would benefit from this method 
of modifying the consistency and texture of foods to improve 
nutritional intake.
    Some commenters asked FNS to allow children in Food Package IV the 
option to receive commercial jarred infant foods in lieu of the cash-
value voucher. However, FNS believes it appropriate that caregivers of 
children who do not have qualifying conditions making them eligible for 
Food Package III, and who need modifications in food consistency, 
receive nutrition education on choosing and preparing foods that meet 
the child's needs, e.g., pureeing fruits and

[[Page 12285]]

vegetables and/or choosing those with soft texture/consistency.
b. Allowance of Infant Formula in Food Package III for Infants
    Food package III is reserved for participants who have one or more 
qualifying conditions that require an exempt infant formula or WIC-
eligible nutritional (formerly WIC-eligible medical food) to supplement 
their nutrition needs, as determined by the participant's health care 
professional. Infants who have a qualifying condition and are 
successfully managed with an infant formula are issued Food Package I 
or II, as deemed appropriate for their age and feeding method.
    Under the interim rule, infants who require a combination of infant 
formula and a WIC-eligible nutritional or exempt infant formula are not 
able to receive both products through a WIC food package. In addition, 
these infants at 6 months of age may not be developmentally ready to 
consume solid foods due to their medical condition and would benefit 
from an increased amount of formula in place of infant foods at that 
timeframe. FNS received 74 comments requesting that infants who are not 
developmentally ready to consume solid foods be allowed increased 
infant formula amounts in lieu of infant foods in Food Package II.
    FNS agrees that there are a small percentage of infants who have a 
qualifying condition, such as prematurity, whose nutritional needs may 
be successfully managed with infant formula alone or a combination of 
infant formula and WIC-eligible nutritionals. These infants are 
considered medically fragile and would benefit from the close medical 
supervision provided under Food Package III. These infants may not be 
ready to consume infant foods at 6 months of age, as would otherwise 
generally healthy term infants, and they may benefit from receiving 
additional formula in lieu of infant foods at that time. Therefore, 
this final rule expands the type of formula authorized to infants with 
qualifying conditions in Food Package III to include infant formula. 
The issuance of infant formula in Food Package III would be strictly 
reserved for those infants who are medically fragile. Infants who do 
not have a qualifying condition and are otherwise generally healthy 
infants will continue to receive Food Packages I and II, as 
appropriate. In Food Package III, infants greater than 6 months of age 
may receive additional infant formula, exempt infant formula or WIC-
eligible nutritionals (formerly WIC-eligible medical food) in lieu of 
infant foods at the same maximum monthly allowance as infants ages 4 
through 5 months of age of the same feeding option. As with exempt 
infant formula and WIC-eligible nutritionals, infants receiving infant 
formula in Food Package III will need medical documentation that meets 
the criteria established in 7 CFR 246.10(d).
11. Liquid Concentrate Infant Formula Amounts and Full Nutrition 
Benefit
    Table 1 in 7 CFR 246.10(e)(9) of the interim rule established the 
full nutrition benefit and the maximum monthly allowances of each 
physical form of infant formula, for each food package category and 
infant feeding variation. The interim rule also described the full 
nutrition benefit as the reconstituted fluid ounce amounts for liquid 
concentrate infant formula (based on a 13 ounce can) which formed the 
basis of substitution rates for other physical forms of infant formula 
(i.e., powder and ready-to-feed infant formula). Providing the full 
nutrition benefit amounts ensure that participants receive a comparable 
nutritional benefit no matter which physical form of infant formula 
they receive.
    For decades, infant formula manufacturers consistently provided 
liquid concentrate and ready-to-feed infant formula in container sizes 
or packaging that evenly divide into the maximum monthly allowance, 
while powder infant formulas traditionally vary in package size across 
manufacturers. FNS has become aware of a shift in the marketplace, such 
that liquid concentrate and ready-to-feed infant formula container 
sizes (i.e., 13 and 32-fluid ounces) are no longer standard for all 
major infant formula manufacturers. Because the maximum monthly 
allowance amounts of liquid infant formula under the interim rule are 
evenly divisible by a 13 ounce standard for liquid concentrate 
(reconstituted) and a 32 ounce standard of ready-to-feed infant 
formula, there is little flexibility to accommodate changes in the 
package size while still providing the full nutrition benefit and not 
exceeding the maximum monthly allowance amount.
    This final rule provides the technical correction of revised 
maximum monthly allowance amounts for liquid concentrate and ready-to-
feed infant formula. The revision of maximum monthly allowance amounts 
for liquid infant formula (i.e., liquid concentrate and ready-to-feed) 
is consistent with the legislative authority granted to the Secretary 
of Agriculture in Section 733 of Public Law 111-80 and reiterated in 
Section 712 of Public Law 112-55, the Consolidated and Further 
Continuing Appropriations Act, 2012 that authorizes State Agencies to 
exceed the current maximum amount of liquid infant formula to ensure 
the full nutrition benefit be provided to participants. This will 
maintain competition in the infant formula market and address recent 
changes in package size availability of liquid concentrate and ready-
to-feed infant formula.
    Liquid concentrate infant formula will now have a separate maximum 
monthly allowance amount different from the full nutrition benefit to 
accommodate market changes in packaging. This provision does not change 
the full nutrition benefit amounts as established in the interim rule. 
The full nutrition benefit will now be defined as the minimum amount of 
reconstituted liquid concentrate infant formula as specified in Table 1 
of 7 CFR 246.10(e)(9) of this rule for each food package category and 
infant feeding option (e.g., Food Package IA fully formula fed, IA-FF).
    Infant formula issuance, whether using monthly issuance or rounding 
methodology, should be based on providing the amount of infant formula 
that most closely provides the full nutrition benefit to all infant 
participants as deemed appropriate based on breastfeeding assessment 
and infant food package and feeding method. At a minimum, State 
agencies must provide the full nutrition benefit to all non-breastfed 
infants. For breastfed infants, even those receiving the fully formula 
fed package, infant formula amounts should be tailored based on the 
assessed needs of the breastfed infant and provide the minimal amounts 
of formula that meets but does not exceed the infant's nutritional 
needs. This final rule adds the definition of full nutrition benefit at 
7 CFR 246.2.
12. Infant Formula Requirements Technical Correction
    A technical correction has been made to infant formula requirements 
in 7 CFR 246. 246.10(e)(1)(iii) to clarify the qualifying conditions 
for the types of supplemental foods (i.e., noncontract brand infant 
formula and any contract brand infant formula that does not meet the 
requirements in Table 4 of 7 CFR 246.10(e)(12)) that may be issued in 
this food package only with medical documentation.

[[Page 12286]]

Procedural Matters

Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility.
    This final rule has been designated a ``significant regulatory 
action,'' under section 3(f) of Executive Order 12866. Accordingly, the 
rule has been reviewed by the Office of Management and Budget.

Regulatory Impact Analysis Summary

    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 final rule. The RIA for this rule was 
published as part of docket number FNS-2006-0037 on 
www.regulations.gov. A summary of the analysis follows:
    Need for Action. This final rule considers public comments 
submitted in response to the interim rule revising the WIC food 
packages published in December 2007 (72 FR 68966). The interim rule 
implemented the first comprehensive revisions to the WIC food packages 
since 1980. The interim rule revised regulations governing the WIC food 
packages to align them more closely with updated nutrition science and 
the infant feeding practice guidelines of the American Academy of 
Pediatrics, promote and support more effectively 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.
    This final rule addresses public comments received on the interim 
rule and makes adjustments that improve clarity of the provisions set 
forth in the interim rule.
    Benefits. The revised food packages were developed to better 
reflect current nutrition science and dietary recommendations, promote 
and support more effectively the establishment of successful long-term 
breastfeeding, provide WIC participants with a wider variety of food 
than do current food packages, and provide WIC State agencies with 
greater flexibility in prescribing food packages to accommodate 
participants with cultural food preferences. The final rule makes 
additional administrative and food package changes that will allow 
local WIC agencies to better meet the nutritional needs and dietary 
preferences of program participants.
    Costs. FNS estimates that the cost of all mandatory and optional 
provisions in this final rule will total $1.17 billion over 5 years 
assuming State implementation beginning May 1, 2014 (for all provisions 
except the split tender and soy-based beverage for children provisions, 
which have effective dates of October 1, 2014) and yogurt for women and 
children with an effective date of April 1, 2015. If the optional 
provisions are adopted by fewer than all State agencies, then the cost 
of the rule will be lower. The cost of the mandatory provisions across 
all State agencies, plus the cost of the optional provisions by State 
agencies that serve half of WIC participants, is estimated to be $999 
million over 5 years.
    Accounting statement. The following accounting statement gives the 
estimated discounted, annualized costs of the rule assuming full State 
agency implementation of the rule's mandatory and optional provisions. 
The figures are computed from the nominal 5-year estimates developed in 
the full RIA. The accounting statement contains figures computed with 7 
percent and 3 percent discount rates.

----------------------------------------------------------------------------------------------------------------
                                                                      Discount rate
                                        Estimate       Year dollar      (percent)           Period covered
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Qualitative: The final rule modifies several provisions of the interim rule based on comments from State and
 local agencies, interest groups, participants, and others. These modifications better fulfill the intent of the
 interim rule and the IOM recommendations that are the basis for the WIC food package changes. The rule would
 increase the quantity of fruits and vegetables contained in the food packages for children to the level
 recommended by the IOM. The rule also gives States and local agencies more flexibility to meet the medical
 needs and cultural preferences of WIC participants. Recent research on WIC participants indicates that changes
 in the WIC food package have resulted in increases in consumption of healthful foods recommended by IOM (see
 RIA text). The effect of the rule, therefore is a benefit to participants and not simply a transfer of Federal
 funds replacing costs that WIC participants would have incurred in the absence of this rule. Because we do not
 quantify the value of the benefits in the impact analysis, and therefore cannot separate them from the
 estimated Federal transfer to WIC participants, we show our entire dollar impact under transfers. No longer
 requiring medical documentation for children to receive soy-based beverage and tofu as milk substitutes will
 save participants some time, although we believe the overall impact on that their time will be minimal and the
 savings will be nominal. There may also be a benefit in that some WIC participants may not have been taking the
 soy-based beverage and tofu substitution because getting medical documentation was presenting a barrier.
 Providing a mechanism to access soy-based beverage and tofu by working with a WIC Competent Professional
 Authority will help to remove that barrier and may result in nutrition benefits for this group of participants.
----------------------------------------------------------------------------------------------------------------
Transfers
----------------------------------------------------------------------------------------------------------------
Annualized Monetized...............          $225.2            2014               7  FY2014-2018
                                    ------------------------------------------------
($millions/year)...................           230.5            2014               3
----------------------------------------------------------------------------------------------------------------
Quantified: The rule contains a mix of mandatory provisions and State options. For purposes of this impact
 analysis we estimate the value of both the mandatory and optional provisions assuming full implementation by
 all WIC State Agencies. The figures shown here are estimates of the value of full implementation of mandatory
 and optional provisions assuming no offsetting savings. The figures shown here which are limited to the food
 benefit, are transfers from the Federal government to WIC participants.
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------

[[Page 12287]]

 
Qualitative: Local and State WIC agencies will incur some administrative costs, other than reporting and
 recordkeeping, to implement the final rule. However, we are unable to quantify the potential increases in
 administrative burden due to the final provisions. These include the costs of training WIC clinic and
 administrative staff and the periodic review and updating of WIC-approved food lists. The State option to
 authorize farmers' markets to accept WIC cash-value vouchers may introduce administrative costs, however in
 general, we anticipate that State Agencies and local WIC providers will be able to absorb the burden associated
 with implementing this rule with 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, as well as adapt to certain ongoing administrative requirements associated with the
 final rule. FNS will continue to provide technical assistance to State and local agencies to assist them in
 implementing the new provisions of the final rule.
----------------------------------------------------------------------------------------------------------------

Regulatory Flexibility Act

    This final rule has been reviewed with regard to the requirements 
of the Regulatory Flexibility Act (RFA) of 1980, (5 U.S.C. 601-612). 
Pursuant to that review, FNS Administrator Audrey Rowe certified that 
this rule would not have a significant 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.
    Although not required by the RFA, FNS prepared a Regulatory 
Flexibility Analysis describing the impact of this interim rule on 
small entities that reflects comments that were received on the 
Regulatory Flexibility Analysis that was included in the WIC Food 
Package interim rule published at 72 FR 68982, December 6, 2007.

Need for and Objectives of the Final Rule

    The interim rule, published in the Federal Register on December 6, 
2007 (72 FR 68966), revised the WIC food packages. The revisions align 
the WIC food packages with the Dietary Guidelines for Americans and 
infant feeding practice guidelines of the American Academy of 
Pediatrics. The interim rule revisions largely reflect recommendations 
made by the Institute of Medicine (IOM) of the National Academies in 
its report, ``WIC Food Packages: Time for a Change,'' with certain cost 
containment and administrative modifications found necessary by the 
Department to ensure cost neutrality. The interim rule allowed FNS to 
obtain feedback on the major changes as recommended by IOM, as well as 
the implementation of procedures, while allowing implementation to move 
forward. State agencies, including Indian Tribal Organizations, were 
required to implement the changes by October 1, 2009, and new food 
packages are now being provided to WIC participants in all States. The 
interim rule comment period ended February 1, 2010. Public comments 
received on the interim rule are reflected in the final rule.
    The interim rule required substantial changes by State and local 
agencies. Overall, implementation proceeded smoothly and all States 
have successfully implemented the changes. This final rule makes a much 
more limited number of modifications than those contained in the 
interim rule and requires less significant changes in response to the 
public comments received. Therefore, the expected effects are minimal 
for FNS and other Federal Agencies. FNS will continue to provide 
technical assistance to State and local agencies to assist them in 
fully implementing the changes. This rule will require State and local 
agencies to make further modifications to their procedures that are far 
less substantial than the changes required under the Interim rule. 
Foreign countries will not be affected.

Description and Estimate of Number of Small Entities to Which the Final 
Rule Would Apply

    This final 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. 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 final rule, small vendors will be impacted differently in each 
State depending upon how that State chooses to meet the new 
requirements. 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 final 
rule.
    A 2011 evaluation conducted by Altarum Institute \7\ sought to 
understand the impact that the WIC food package changes had on small 
stores. The study demonstrated that most small WIC stores were able to 
maintain their authorization with the WIC Program during the period the 
food package changes were implemented. Small stores appear to have 
added healthy foods to their inventory in response to the WIC food 
package changes. The report concludes that adequate vendor preparation 
likely factored into the overall success of implementation, and cites 
the need for ongoing engagement of these and other WIC stakeholders.
---------------------------------------------------------------------------

    \7\ Altarum Institute 2011. Impact of the Revised WIC Food 
Package on Small WIC Vendors: Insight from a Four State Evaluation.
---------------------------------------------------------------------------

Description of Projected Reporting, Recordkeeping, and Other Compliance 
Requirements

    Modifications included in the final rule to eliminate certain 
medical documentation requirements imposed by the interim rule will 
decrease the Information Collection Burden associated with this rule.

Steps Taken To Minimize Significant Economic Impact on Small Entities, 
and Significant Alternatives Considered

    FNS considered significant alternatives in developing the interim 
rule including those that may reduce the indirect impact on small 
business. These considerations included (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 the 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

[[Page 12288]]

children up to age 5 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. Therefore, this final rule 
retains those requirements.
    FNS did, however, modify the new food provisions in an effort to 
mitigate the impact on small entities. As in the past, 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. The interim rule added 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 interim rule allowed canned, frozen and dried fruits and vegetables 
to be substituted for fresh produce. These provisions are all retained 
in this final rule.
    The interim rule authorized State agencies the option to allow 
participants to pay the difference if the fruit and vegetable purchase 
exceeds the value of the cash-value voucher, a transaction known as 
``split tender.'' In response to public comments received on the 
interim rule, this final rule requires State agencies to allow split 
tender transactions with the cash-value voucher.

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local and tribal 
governments and the private sector. Under section 202 of the UMRA, the 
Department generally must prepare a written statement, including a cost 
benefit analysis, for proposed and final rules with ``Federal 
mandates'' that may result in expenditures by State, local or tribal 
governments, in the aggregate, or the private sector, of $100 million 
or more in any one year. When such a statement is needed for a rule, 
Section 205 of the UMRA generally requires the Department to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the most cost effective or least burdensome alternative that achieves 
the objectives of the rule.
    This final rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) for State, local and tribal 
governments or the private sector of $100 million or more in any one 
year. Thus, the rule is not subject to the requirements of sections 202 
and 205 of the UMRA.

Executive Order 12372

    The WIC Program is listed in the Catalog of Federal Domestic 
Assistance Programs under 10.557. For the reasons set forth in the 
final rule in 7 CFR part 3015, subpart V, and related Notice (48 FR 
29115, 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 13121.

Prior Consultation With State Officials

    Since publication of the interim rule revising the WIC food 
packages, FNS has obtained input from WIC State and local agency staff 
about the provisions and implementation of the changes. Examples of the 
different forums and methods FNS has used to solicit WIC State and 
local agency staff input on the WIC food packages include the 
following:
     Hosting annual meetings 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 WIC, including aspects related to the 
authorized foods and food packages;
     Consulting and collaborating with the National WIC 
Association (NWA) on a wide variety of WIC issues, including those 
related to the WIC food packages. NWA is a non-profit organization that 
was founded in 1983 by State and local agencies that administer the WIC 
Program. NWA's paid membership includes 72 of the 90 WIC State 
agencies, 813 local agencies, 7 State WIC Associations, and 27 
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; 
and
     Regular meetings and consultation with State health 
officials and other WIC stakeholders, including the medical community, 
advocacy groups, and retailers.

Nature of Concerns and the Need To Issue This Rule

    This final rule considers public comments submitted in response to 
the interim rule revising the WIC food packages published in December 
2007 (72 FR 68966). The interim rule implemented the first 
comprehensive revisions to the WIC food packages since 1980. This final 
rule addresses public comments received on the interim rule and makes 
adjustments that improve clarity of the provisions set forth in the 
interim rule.

Extent to Which We Meet Those Concerns

    FNS has considered the impact of final 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.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This final rule is not 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 and timely implementation. This rule is not intended to 
have retroactive effect unless so specified in the DATES section of the 
final rule. Prior to any judicial challenge to the provisions of the 
final rule, all applicable administrative procedures must be exhausted.

Civil Rights Impact Analysis

    The intent of this final rulemaking is not to limit participation 
or to have an adverse effect on current participants. FNS does not 
expect any protected populations to be adversely affected by the 
implementation of the requirements in this rule. State agencies must 
ensure participant access to supplemental foods. The foods available to 
WIC participants as a result of this final rule are intended to broaden 
the appeal of the WIC food packages for all groups

[[Page 12289]]

and encourage participation in WIC. This final rule revises certain 
provisions to better address the needs of participants with certain 
medical conditions, and provides State agencies increased flexibility 
in prescribing culturally appropriate packages for diverse groups. FNS 
does not anticipate this rulemaking will result in any adverse civil 
rights impacts.

Executive Order 13175

    Executive Order 13175 requires Federal agencies to consult and 
coordinate with tribes on a government-to-government basis on policies 
that have tribal implications, including regulations, legislative 
comments or proposed legislation, and other policy statements or 
actions that have substantial direct effects on one or more Indian 
tribes, on the relationship between the Federal Government and Indian 
tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian tribes. In late 2010 and early 2011, 
USDA engaged in a series of consultative sessions to obtain input by 
Tribal officials or their designees concerning the impact of this rule 
on the tribe or Indian Tribal governments, or whether this rule may 
preempt Tribal law. USDA did not receive any input during these 
sessions that this rule preempts any Tribal law. Input received 
relative to this rule included overall satisfaction with the new WIC 
foods, especially the fruits and vegetables and whole grains, and 
changes related to supporting breastfeeding mothers. Some tribes 
reported that WIC participants who were enrolled in WIC during the 
transition from the previous food packages to the revised food packages 
expressed displeasure with issuance of lower fat milks and less cheese. 
The input from Indian tribes during these sessions was consistent with 
the general comments received for the interim rule, and have been 
addressed in this final rule. Reports from these consultations will be 
made part of the USDA annual reporting on Tribal Consultation and 
Collaboration. USDA will respond in a timely and meaningful manner to 
all Tribal government requests for consultation concerning this rule 
and will provide additional venues, such as webinars and 
teleconferences, to periodically host collaborative conversations with 
Tribal officials or their designees concerning ways to improve this 
rule in Indian country.

Paperwork Reduction Act of 1995

    The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR 
1320) requires that the Office of Management and Budget (OMB) approve 
all collections of information by a Federal agency before they can be 
implemented. Respondents are not required to respond to any collection 
of information unless it displays a current valid OMB control number. 
This final rule changes the information collection burden previously 
approved under OMB 0584-0545. Implementation of the data collection 
requirements resulting from this final rule is contingent upon OMB 
approval under the Paperwork Reduction Act of 1995.
    The proposed food package rule was published in the Federal 
Register [71 FR 44784] with a 60-day notice on August 7, 2006, which 
provided the public an opportunity to submit comments on the 
information collection burden resulting from the proposed rule. 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.
    The interim food package rule was published in the Federal Register 
[72 FR 68966] on December 6, 2007, and included an estimated annual 
information collection burden of 14,919 burden hours, which was 
approved as OMB Number 0584-0545. These information collection burden 
hours were merged into the information collection, WIC Program 
Reporting and Recordkeeping Requirements, OMB Number 0584-0043, 
changing the total approved burden hours for OMB Number 0584-0043 from 
3,595,075 to 3,609,994. Information collection OMB Number 0584-0545 was 
then discontinued. Information collection OMB Number 0584-0043 was 
renewed as of December 27, 2012, changing the total approved burden 
hours from 3,609,994 to 4,024,697.
    In this final rule, FNS will no longer require a health care 
professional licensed to write medical prescriptions to provide 
documentation for children to receive soy-based beverage and tofu as 
milk substitutes. Also, FNS will no longer require documentation from a 
health care professional licensed to write medical prescriptions for 
women to receive tofu in excess of the maximum substitution allowance. 
As a result of this final rulemaking, the overall information 
collection burden associated with OMB Number 0584-0043 is estimated to 
have decreased by 4,200 burden hours annually due to program changes in 
this rulemaking. The total estimated burden hours for OMB Number 0584-
0043 will decrease from 4,024,697 to 4,020,497.
    The breakdown of the changes is described below:
    OMB Number 0584-0043;
    WIC Program Reporting and Recordkeeping Requirements; expiration 
date December 31, 2015.
    Type of Request: Revision of a currently approved collection.
    Abstract: Federal regulations at 7 CFR 246.10(d)(1)(vi) and (viii) 
require medical documentation for the issuance of soy-based beverage 
and tofu for children, and tofu above the maximum substitution amount 
for women. Federal regulations at 7 CFR 246.10(d)(1)(v) require medical 
documentation for the issuance of supplemental foods to participants 
who receive Food Package III (for participants with qualifying 
conditions).
    Under the interim rule, medical documentation by a health care 
professional licensed to write medical prescriptions is required for 
the issuance of certain milk alternatives for children and women. A 
total of 180 comment letters (53 of these form letters) opposed this 
requirement, primarily the documentation for children to receive soy-
based beverage. Commenters stated that the provision is unnecessary, 
costly and burdensome for participants and physicians, creates barriers 
to services, and undermines FNS' efforts to provide foods that meet the 
cultural needs of participants. The NWA and the American Dietetic 
Association (now known as the Academy of Nutrition and Dietetics) 
stressed that WIC dietitians and nutritionists are health professionals 
trained and capable of doing a complete nutrition assessment, selecting 
WIC foods, and providing appropriate education to participants and 
caregivers, in consultation with the health care provider when 
warranted.
    Based on the experiences cited by WIC State and local agencies 
related to medical documentation throughout implementation of the new 
food packages, FNS will no longer require a health care professional 
licensed to write medical prescriptions to provide documentation for 
children to receive soy-based beverage and tofu as milk substitutes. 
Also, FNS will no longer require documentation from a health care 
professional licensed to write medical prescriptions for women to 
receive tofu in excess of the maximum substitution allowance.

Estimate of Burden

    This final rule amends the supplemental foods that require medical 
documentation as described in 7 CFR

[[Page 12290]]

246.10(d)(1) However, medical documentation continues to be required 
for issuance of supplemental foods in Food Package III. After revising 
to reflect the changes made by this final rule, the total annual 
reporting and recordkeeping burden estimated for medical documentation 
is decreased by 4,200 hours.
    FNS estimates that approximately 1 percent of participants (89,606) 
will be issued supplemental foods under Food Package III. FNS estimates 
that it will take three minutes (0.05 hours) for the documentation 
required to issue the authorized foods, thus resulting in an estimated 
reporting burden for participants of 8,961 hours (89,606 total 
participants x 0.05 person hours x 2 certification periods per year). 
This results in a decrease in the approved reporting burden under OMB 
0584-0043 for participants providing medical documentation for 
supplemental foods from 13,160 burden hours to 8,961 burden hours (a 
decrease of 4,200 burden hours).
    FNS will submit an Information Collection Request clearance package 
to OMB based on the provisions of this final rule. These amended 
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 
announcing OMB approval.

E-Government Act Compliance

    The Food and Nutrition Service is committed to complying with the 
E-Government Act, 2002, 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 NUTRTION PROGRAM FOR WOMEN, INFANTS 
AND CHILDREN

0
1. The authority citation for 7 CFR part 246 continues to read as 
follows:

    Authority:  42 U.S.C. 1786.

0
2. In Sec.  246.2:
0
a. Add a definition for ``Farmers' market'' in alphabetical order;
0
b. Add a definition for ``Full nutrition benefit'' in alphabetical 
order;
0
c. Remove the definition heading ``WIC-eligible medical foods'' and add 
in its place ``WIC-eligible nutritionals for participants with 
qualifying conditions (hereafter referred to as ``WIC-eligible 
nutritionals)''; and
0
d. Remove the term ``WIC-eligible medical foods'' and add in its place 
the term ``WIC-eligible nutritionals'' wherever it appears.
0
The revisions and additions read as follows:


Sec.  246.2  Definitions.

* * * * *
    Farmers' market means an association of local farmers who assemble 
at a defined location for the purpose of selling their produce directly 
to consumers.
* * * * *
    Full nutrition benefit means the minimum amount of reconstituted 
fluid ounces of liquid concentrate infant formula as specified in Table 
1 of Sec.  246.10(e)(9) for each food package category and infant 
feeding variation (e.g., Food Package IA fully formula fed, IA-FF).
* * * * *
0
3. In Sec.  246.4:
0
a. Amend paragraph (a)(11)(iii) by removing ``Sec.  246.10(b)(1)'' and 
adding in its place ``Sec.  246.10(b)(2)(i)''.
0
b. Revise paragraph (a)(14)(iii);
0
c. Redesignate paragraphs (a)(14)(v) through (xvii) as paragraphs (vi) 
through (xviii) and add a new paragraph (a)(14)(v);
0
d. Amend newly designated paragraph (a)(14)(vi) by removing ``Sec.  
246.12(k)(1)(i)'' and adding in its place ``Sec.  246.12(l)(1)(i)'';
0
e. Revise newly designated paragraph (a)(14)(xii); and
0
f. Amend paragraph (a)(18) by removing the words ``and food vendors'' 
and adding in their place the phrase ``, food vendors, farmers and 
farmers' markets''.
    The revisions and additions read as follows:


Sec.  246.4  State plan.

    (a) * * *
    (14) * * *
    (iii) A sample vendor, farmer and/or farmers' market, if 
applicable, agreement. The sample vendor agreement must include the 
sanction schedule, the process for notification of violations in 
accordance with Sec.  246.12(l)(3), and the State agency's policies and 
procedures on incentive items in accordance with Sec.  
246.12(g)(3)(iv), which may be incorporated as attachments or, if the 
sanction schedule, the process for notification of violations, or 
policies on incentive items are in the State agency's regulations, 
through citations to the regulations. State agencies that intend to 
delegate signing of vendor, farmer and/or farmers' market agreements to 
local agencies must describe the State agency supervision and 
instruction that will be provided to ensure the uniformity and quality 
of local agency activities;
* * * * *
    (v) Farmer monitoring. The system for monitoring farmers and/or 
farmers' markets within its jurisdiction, if applicable, for compliance 
with program requirements;
* * * * *
    (xii) Vendor, farmer and/or farmers' market training. The 
procedures the State agency will use to train vendors (in accordance 
with Sec.  246.12(i)), farmers and/or farmers' markets (in accordance 
with Sec.  246.12(v)). State agencies that intend to delegate any 
aspect of training to a local agency, contractor, vendor or farmer 
representative must describe the supervision and instructions that will 
be provided by the State agency to ensure the uniformity and quality of 
vendor, farmer and/or farmers' market training;
* * * * *
0
4. In Sec.  246.10:
0
a. Remove the term ``WIC-eligible medical food'' and add in its place 
the term ``WIC-eligible nutritional'' wherever it appears; and remove 
the term ``WIC-eligible medical foods'' and replace it with ``WIC-
eligible nutritionals'' wherever it appears;
0
b. Revise paragraph (b)(1)(i);
0
c. Amend paragraph (b)(2)(ii)(C) by removing the words ``age and'' 
before ``nutritional'' and adding the words ``and breastfeeding'' after 
``nutritional'';
0
d. Amend paragraph (d)(1)(ii) by removing the phrase ``a child'' and 
adding in its place the phrase ``an infant, child,'';
0
e. Remove paragraphs (d)(1)(vi) through (d)(1)(viii);
0
f. Redesignate paragraph (d)(1)(ix) as (d)(1)(vi);
0
g. Revise the heading of paragraph (d)(2);
0
h. Amend paragraph (d)(2)(ii) by adding a space between ``formula'' and 
``and'';
0
i. Revise paragraph (d)(3)(i);
0
j. Revise paragraph (d)(4)(ii)(D);
0
k. Revise paragraphs (e) introductory text through (e)(1)(iii);
0
l. Revise paragraph (e)(1)(v);
0
m. Revise paragraph (e)(2)(ii);
0
n. Revise paragraph (e)(2)(iv);
0
o. Revise paragraph (e)(3)(v);

[[Page 12291]]

0
p. Revise paragraphs (e)(4)(ii) through (e)(7)(ii); and
0
q. Revise paragraphs (e)(9) through (e)(12).
    The revisions and additions read as follows:


Sec.  246.10  Supplemental foods.

* * * * *
    (b) * * *
    (1) * * *
    (i) Establish criteria in addition to the minimum Federal 
requirements in Table 4 of paragraph (e)(12) of this section for the 
supplemental foods in their States, except that the State agency may 
not selectively choose which eligible fruits and vegetables are 
available to participants. These State agency criteria could address, 
but not be limited to, other nutritional standards, competitive cost, 
State-wide availability, and participant appeal. For eligible fruits 
and vegetables, State agencies may restrict packaging, e.g., plastic 
containers, and package sizes, such as single serving, of processed 
fruits and vegetables available for purchase with the cash-value 
voucher. In addition, State agencies may identify certain processed 
WIC-eligible fruits and vegetables on food lists where the potential 
exists for vendor or participant confusion in determining authorized 
WIC-eligible items.
* * * * *
    (d) * * *
    (2) Medical documentation for other supplemental foods. * * *
    (3) * * *
    (i) Made a medical determination that the participant has a 
qualifying condition as described in paragraphs (e)(1) through (e)(7) 
of this section that dictates the use of the supplemental foods, as 
described in paragraph (d)(1) of this section; and
* * * * *
    (4) * * *
    (ii) * * *
    (D) The qualifying condition(s) for issuance of the authorized 
supplemental food(s) requiring medical documentation, as described in 
paragraphs (e)(1) through (e)(7) of this section; and
* * * * *
    (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 participants. Breastfeeding 
assessment and the mother's plans for breastfeeding serve as the basis 
for determining food package issuance for all breastfeeding women. The 
intent of the WIC Program is that all breastfeeding women be supported 
to exclusively breastfeed their infants and to choose the fully 
breastfeeding food package without infant formula. Breastfeeding 
mothers whose infants receive formula from WIC are to be supported to 
breastfeed to the maximum extent possible with minimal supplementation 
with infant formula. Formula amounts issued to breastfed infants are to 
be tailored to meet but not exceed the infant's nutritional needs. The 
seven food packages are as follows:
    (1) Food Package I--Infants birth through 5 months.--(i) 
Participant category served. This food package is designed for issuance 
to infant participants from birth through age 5 months who do not have 
a condition qualifying them to receive Food Package III. The following 
infant feeding variations are defined for the purposes of assigning 
food quantities and types in Food Packages I: Fully breastfeeding (the 
infant doesn't receive formula from the WIC Program); partially 
(mostly) breastfeeding (the infant is breastfed but also receives 
infant formula from WIC up to the maximum allowance described for 
partially (mostly) breastfed infants in Table 1 of paragraph (e)(9) of 
this section; and fully formula fed (the infant is not breastfed or is 
breastfed minimally (the infant receives infant formula from WIC in 
quantities that exceed those allowed for partially (mostly) breastfed 
infants).
    (ii) Infant feeding age categories.--(A) Birth to one month. Two 
infant food packages are available during the first month after birth--
fully breastfeeding and fully formula-feeding. State agencies also have 
the option to make available a third food package containing not more 
than one can of powder infant formula in the container size that 
provides closest to 104 reconstituted fluid ounces to breastfed infants 
on a case-by-case basis. The infant receiving this food package is 
considered partially breastfeeding. State agencies choosing to make 
available a partially breastfeeding package in the first month may not 
standardize issuance of this food package. Infant formula may not be 
routinely provided during the first month after birth to breastfed 
infants in order to support the successful establishment of 
breastfeeding.
    (B) One through 5 months. Three infant food packages are available 
from 1 months through 5 months--fully breastfeeding, partially (mostly) 
breastfeeding, or fully formula-fed.
    (iii) Infant formula requirements. This food package provides iron-
fortified infant formula that is not an exempt infant formula and that 
meets the requirements in Table 4 of paragraph (e)(12) of this section. 
The issuance of any contract brand or noncontract brand infant formula 
that contains less than 10 milligrams of iron per liter (at least 1.5 
milligrams iron per 100 kilocalories) at standard dilution is 
prohibited. Except as specified in paragraph (d) of this section, local 
agencies must issue as the first choice of issuance the primary 
contract infant formula, as defined in Sec.  246.2, with all other 
infant formulas issued as an alternative to the primary contract infant 
formula. Noncontract brand infant formula and any contract brand infant 
formula that does not meet the requirements in Table 4 of paragraph 
(e)(12) of this section may be issued in this food package only with 
medical documentation of the qualifying condition. A health care 
professional licensed by the State to write prescriptions must make a 
medical determination and provide medical documentation that indicates 
the need for the infant formula. For situations that do not require the 
use of an exempt infant formula, such determinations include, but are 
not limited to, documented formula intolerance, food allergy or 
inappropriate growth pattern. Medical documentation must meet the 
requirements described in paragraph (d) of this section.
* * * * *
    (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 nutritionals are 
authorized only in Food Package III. The maximum monthly allowances, 
allowed options and substitution rates of supplemental foods for 
infants in Food Packages I are stated in Table 1 of paragraph (e)(9) of 
this section.
    (2) * * *
    (ii) Infant food packages. Three food packages for infants 6 
through 11 months are available -- fully breastfeeding, partially 
(mostly) breastfeeding, or fully formula fed.
* * * * *
    (iv) Authorized categories of supplemental foods. Infant formula, 
infant cereal, and infant foods are the categories of supplemental 
foods authorized in this food package. The maximum monthly allowances, 
allowed options and substitution rates of supplemental foods for 
infants in Food Packages II are stated in Table 1 of paragraph (e)(9) 
of this section.
* * * * *
    (3) * * *

[[Page 12292]]

    (v) Authorized categories of supplemental foods. The supplemental 
foods authorized in this food package require medical documentation for 
issuance and include WIC formula (infant formula, exempt infant 
formula, and WIC-eligible nutritionals), infant cereal, infant foods, 
milk, cheese, eggs, canned fish, fresh fruits and vegetables, breakfast 
cereal, whole wheat/whole grain bread, juice, legumes and/or peanut 
butter. The maximum monthly allowances, allowed options and 
substitution rates of supplemental foods for infants in Food Package 
III are stated in Table 1 of paragraph (e)(9) of this section. The 
maximum monthly allowances, allowed options, and substitution rates of 
supplemental foods for children and women in Food Package III are 
stated in Table 3 of paragraph (e)(11) of this section.
* * * * *
    (4) * * *
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fresh fruits and vegetables, whole wheat/whole grain 
bread, eggs, and legumes or peanut butter are the categories of 
supplemental foods authorized in this food package. The maximum monthly 
allowances, allowed options and substitution rates of supplemental 
foods for children in Food Package IV are stated in Table 2 of 
paragraph (e)(10) of this section.
    (5) Food Package V--Pregnant and partially (mostly) 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 partially (mostly) 
breastfeeding women participants, up to 1 year postpartum, who do not 
have a condition qualifying them to receive Food Package III and whose 
partially (mostly) 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 
partially (mostly) breastfeeding more than one infant from the same 
pregnancy, pregnant women fully or partially breastfeeding singleton 
infants, and women participants pregnant with two or more fetuses, 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, fresh fruits and vegetables, whole wheat/whole grain 
bread, eggs, legumes and peanut butter are the categories of 
supplemental foods authorized in this food package. The maximum monthly 
allowances, allowed options and substitution rates of supplemental 
foods for women in Food Package V are stated in Table 2 of paragraph 
(e)(10) 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 (mostly) breastfed infants as described in Table 1 of 
paragraph (e)(9) of this section, and who do not have a condition 
qualifying them to receive Food Package III.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fresh fruits and vegetables, eggs, and legumes or peanut 
butter are the categories of supplemental foods authorized in this food 
package. The maximum monthly allowances, allowed options and 
substitution rates of supplemental foods for women in Food Package VI 
are stated in Table 2 of paragraph (e)(10) 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 exclusively breastfeeding their infants), and who do not have a 
condition qualifying them to receive Food Package III. This food 
package is also designed for issuance to women participants pregnant 
with two or more fetuses, women participants partially (mostly) 
breastfeeding multiple infants from the same pregnancy, and pregnant 
women who are also partially (mostly) breastfeeding singleton infants, 
and who do not have a condition qualifying them to receive Food Package 
III. Women participants fully breastfeeding multiple infants from the 
same pregnancy receive 1.5 times the supplemental foods provided in 
Food Package VII.
    (ii) Authorized categories of supplemental foods. Milk, cheese, 
breakfast cereal, juice, fresh fruits and vegetables, whole wheat/whole 
grain bread, eggs, legumes, peanut butter, and canned fish are the 
categories of supplemental foods authorized in this food package. The 
maximum monthly allowances, allowed options and substitution rates of 
supplemental foods for women in Food Package VII are stated in Table 2 
of paragraph (e)(10) of this section.
* * * * *
    (9) Full nutrition benefit and maximum monthly allowances, options 
and substitution rates of supplemental foods for infants in Food 
Packages I, II and III are stated in Table 1 as follows:

       Table 1--Full Nutrition Benefit (FNB) and Maximum Monthly Allowances (MMA) of Supplemental Foods for Infants in Food Packages I, II and III
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          Fully formula fed (FF)           Partially (mostly) breastfed (BF/FF)            Fully breastfed (BF)
                                 -----------------------------------------------------------------------------------------------------------------------
                                                                          Food Packages I-BF/
                                  Food Packages I-FF                        FF & III BF/FF     Food Packages II-
            Foods \1\               & III-FF  A: 0     Food Packages II-  (A: 0 to 1 month 2   BF/FF & III BF/FF   Food Package I-BF  Food Package II-BF
                                   through 3 months     FF & III-FF  6    3)  B: 1 through 3     6 through 11     0 through 5 months      6 through 11
                                    B: 4 through 5     through 11 months     months  C: 4           months                                  months
                                        months                             through 5 months
--------------------------------------------------------------------------------------------------------------------------------------------------------
WIC Formula 4 5 6 7 8...........  A: FNB=806 fl oz,   FNB=624 fl oz,      A: 104 fl oz        FNB=312 fl oz,
                                   MMA=823 fl oz,      MMA=630 fl oz,      reconstituted       MMA=315 fl oz,
                                   reconstituted       reconstituted       powder.             reconstituted
                                   liquid              liquid             B: FNB=364 fl oz,    liquid
                                   concentrate or      concentrate.        MMA=388 fl oz,      concentrate or
                                   832 fl. oz. RTF    or 643 fl. oz RTF    reconstituted       338 fl oz RTF or
                                   or 870 fl oz        or 696 fl oz        liquid              384 fl oz
                                   reconstituted       reconstituted       concentrate or      reconstituted
                                   powder.             powder.             384 fl oz RTF or    powder.
                                                                           435 fl oz
                                                                           reconstituted
                                                                           powder.

[[Page 12293]]

 
                                  B: FNB=884 fl oz,
                                   MMA=896 fl oz,
                                   reconstituted
                                   liquid
                                   concentrate or
                                   913 fl oz RTF or
                                   960 fl oz
                                   reconstituted
                                   powder.
                                                                          C: FNB=442 fl oz,
                                                                           MMA=460 fl oz,
                                                                           reconstituted
                                                                           liquid
                                                                           concentrate or
                                                                           474 fl oz RTF or
                                                                           522 fl oz
                                                                           reconstituted
                                                                           powder.
Infant Cereal 9 11..............  ..................  24 oz.............  ..................  24 oz.............  ..................  24 oz.
Infant food fruits and            ..................  128 oz............  ..................  128 oz............  ..................  256 oz.
 vegetables 9 10 11 12 13.
Infant food meat \9\............  ..................  ..................  ..................  ..................  ..................  77.5 oz.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 1 footnotes: (Abbreviations in order of appearance in table): FF = fully formula fed; BF/FF = partially (mostly) breastfed; BF = fully breastfed;
  RTF = Ready-to-feed; 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. The competent
  professional authority (CPA) is authorized to determine nutritional risk and prescribe supplemental foods as established by State agency policy in
  Food Packages I and II. In Food Package III, the CPA, as established by State agency policy, is authorized to determine nutritional risk and prescribe
  supplemental foods per medical documentation.
\2\ State agencies have the option to issue not more than one can of powder infant formula in the container size that provides closest to 104
  reconstituted fluid ounces to breastfed infants on a case-by-case basis.
\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 nutritionals. Infant formula may be issued for infants in Food Packages I,
  II and III. Medical documentation is required for issuance of infant formula, exempt infant formula, WIC-eligible nutritionals, and other supplemental
  foods in Food Package III. Only infant formula may be issued for infants in Food Packages I and II.
\5\ The full nutrition benefit is defined as the minimum amount of reconstituted fluid ounces of liquid concentrate infant formula as specified for each
  infant food package category and feeding variation (e.g., Food Package IA-fully formula fed).
\6\ 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.
\7\ State agencies must provide at least the full nutrition benefit authorized to non-breastfed infants up to the maximum monthly allowance for the
  physical form of the product specified for each food package category. State agencies must issue whole containers that are all the same size of the
  same physical form. Infant formula amounts for breastfed infants, even those in the fully formula fed category should be individually tailored to the
  amounts that meet their nutritional needs.
\8\ State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the
  full nutrition benefit. State agencies must use the methodology described in accordance with paragraph (h)(1) of this section.
\9\ 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.
\10\ At State agency option, for infants 6-12 months of age, 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. State agencies may also substitute fresh bananas at a rate of 1 banana per 4 ounces of jarred infant food
  fruit, up to a maximum of 16 ounces.
\11\ In lieu of infant foods (cereal, fruit and vegetables), infants greater than 6 months of age in Food Package III may receive infant formula, exempt
  infant formula or WIC-eligible nutritionals at the same maximum monthly allowance as infants ages 4 through 5 months of age of the same feeding
  option.
\12\ At State agency option, infants 9 months through 11 months in Food Packages II and III may receive a cash-value voucher to purchase fresh (only)
  fruits and vegetables in lieu of a portion of the infant food fruits and vegetables. Partially (mostly) breastfed infants and fully formula fed
  infants may receive a $4 cash-value voucher plus 64 ounces of infant food fruits and vegetables; fully breastfeeding infants may receive a $8 cash-
  value voucher plus 128 ounces of infant food fruit and vegetables.
\13\ State agencies may not categorically issue cash-value vouchers for infants 9 months through 11 months. The cash-value voucher is to be provided to
  the participant only after an individual nutrition assessment, as established by State agency policy, and is optional for the participant, i.e., the
  mother may choose to receive either the maximum allowance of jarred foods or a combination of jarred foods and a fruit and vegetable cash-value
  voucher for her infant. State agencies must ensure that appropriate nutrition education is provided to the caregiver addressing safe food preparation,
  storage techniques, and feeding practices to make certain participants are meeting their nutritional needs in a safe and effective manner.

    (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:

[[Page 12294]]



 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 (Mostly)   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 11.  22 qt 7 8 9 10 12.  16 qt 7 8 9 10 12.  24 qt 7 8 9 10 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.
Fresh fruits and vegetables 14    $8.00 in cash-      $10.00 in cash-     $10.00 in cash-     $10.00 in cash-
 15.                               value vouchers.     value vouchers.     value vouchers.     value vouchers.
Whole wheat or whole grain bread  2 lb..............  1 lb..............  N/A...............  1 lb.
 \16\.
Fish (canned)...................  N/A...............  N/A...............  N/A...............  30 oz.
Legumes, dry \17\ and/or Peanut   1 lb or 18 oz.....  1 lb and 18 oz....  1 lb or 18 oz.....  1 lb and 18 oz.
 butter.
----------------------------------------------------------------------------------------------------------------
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. The competent professional authority (CPA) is authorized to determine nutritional risk and
  prescribe supplemental foods as established by State agency policy.
\2\ Food Package V is issued to two categories of WIC participants: Women participants with singleton
  pregnancies; breastfeeding women whose partially (mostly) breastfed infants receive formula from the WIC
  Program in amounts that do not exceed the maximum formula allowances, 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 infants receive more than the maximum infant formula allowances, 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 four categories of WIC participants: Fully breastfeeding women whose infants
  do not receive formula from the WIC Program; women pregnant with two or more fetuses; women partially (mostly)
  breastfeeding multiple infants from the same pregnancy; and pregnant women who are also fully or partially
  (mostly) breastfeeding singleton infants.
\5\ Women fully breastfeeding multiple infants from the same pregnancy 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 is the standard milk for issuance to 1-year-old children (12 through 23 months). At State agency
  option, fat-reduced milks may be issued to 1-year-old children for whom overweight or obesity is a concern.
  The need for fat-reduced milks for 1-year-old children must be based on an individual nutritional assessment
  and consultation with the child's health care provider if necessary, as established by State agency policy.
  Lowfat (1%) or nonfat milks are the standard milk for issuance to children >= 24 months of age and women.
  Reduced fat (2%) milk is authorized only for participants with certain conditions, including but not limited
  to, underweight and maternal weight loss during pregnancy. The need for reduced fat (2%) milk for children >=
  24 months of age (Food Package IV) and women (Food Packages V-VII) must be based on an individual nutritional
  assessment as established by State agency policy.
\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.
\9\ For children and women, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of
  milk. For children and women in Food Packages IV-VI, no more than 1 pound of cheese may be substituted. For
  fully breastfeeding women in Food Package VII, no more than 2 pounds of cheese may be substituted for milk.
  State agencies do not have the option to issue additional amounts of cheese beyond these maximums even with
  medical documentation. (No more than a total of 4 quarts of milk may be substituted for a combination of
  cheese, yogurt or tofu for children and women in Food Packages IV-VI. No more than a total of 6 quarts of milk
  may be substituted for a combination of cheese, yogurt or tofu for women in Food Package VII.)
\10\ For children and women, yogurt may be substituted for fluid milk at the rate of 1 quart of yogurt per 1
  quart of milk; a maximum of 1 quart of milk can be substituted. Additional amounts of yogurt are not
  authorized. Whole yogurt is the standard yogurt for issuance to 1-year-old children (12 through 23 months). At
  State agency option, lowfat or nonfat yogurt may be issued to 1-year-old children for whom overweight and
  obesity is a concern. The need for lowfat or nonfat yogurt for 1-year-old children must be based on an
  individual nutritional assessment and consultation with the child's health care provider if necessary, as
  established by State agency policy. Lowfat or nonfat yogurts are the only types of yogurt authorized for
  children >= 24 months of age and women. (No more than a total of 4 quarts of milk may be substituted for a
  combination of cheese, yogurt or tofu for children and women in Food Packages IV-VI. No more than a total of 6
  quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in Food Package VII.)
\11\ For children, issuance of tofu and soy-based beverage as substitutes for milk must be based on an
  individual nutritional assessment and consultation with the participant's health care provider if necessary,
  as established by State agency policy. Such determination can be made for situations that include, but are not
  limited to, milk allergy, lactose intolerance, and vegan diets. Soy-based beverage may be substituted for milk
  for children on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted for
  milk for children at the rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of
  milk may be substituted for a combination of cheese, yogurt or tofu for children in Food Package IV.)
  Additional amounts of tofu may be substituted, up to the maximum allowance for fluid milk for lactose
  intolerance or other reasons, as established by State agency policy.
\12\ For women, soy-based beverage may be substituted for milk on a quart for quart basis up to the total
  maximum allowance of milk. Tofu may be substituted for milk at the rate of 1 pound of tofu per 1 quart of
  milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu
  for women in Food Packages V and VI. No more than a total of 6 quarts of milk may be substituted for a
  combination of cheese, yogurt or tofu for women in Food Package VII.). Additional amounts of tofu may be
  substituted, up to the maximum allowances for fluid milk, for lactose intolerance or other reasons, as
  established by State agency policy.
\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.

[[Page 12295]]

 
\14\ Both fresh fruits and fresh vegetables must be authorized by State agencies. Processed fruits and
  vegetables, i.e., canned (shelf-stable), frozen, and/or dried fruits and vegetables may also be authorized to
  offer a wider variety and choice for participants. State agencies may choose to authorize one or more of the
  following processed fruits and vegetables: canned fruit, canned vegetables, frozen fruit, frozen vegetables,
  dried fruit, and/or dried vegetables. The cash-value voucher may be redeemed for any eligible fruit and
  vegetable (refer to Table 4 of paragraph (e)(12) of this section and its footnotes). Except as authorized in
  paragraph (b)(1)(i) of this section, State agencies may not selectively choose which fruits and vegetables are
  available to participants. For example, if a State agency chooses to offer dried fruits, it must authorize all
  WIC-eligible dried fruits.
\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\ Whole wheat and/or whole grain bread must be authorized. State agencies have the option to also authorize
  brown rice, bulgur, oatmeal, whole-grain barley, whole wheat macaroni products, or soft corn or whole wheat
  tortillas on an equal weight basis.
\17\ Canned legumes may be substituted for dry legumes at the rate of 64 oz. (e.g., four 16-oz cans) of canned
  beans for 1 pound dry beans. In Food Packages V and VII, both beans and peanut butter must be provided.
  However, when individually tailoring Food Packages V or VII for nutritional reasons (e.g., food allergy,
  underweight, participant preference), State agencies have the option to authorize the following substitutions:
  1 pound dry and 64 oz. canned beans/peas (and no peanut butter); or 2 pounds 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 (MMA) of Supplemental Foods for Children and Women With Qualifying
                                         Conditions 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 11 12    22 qt 9 10 11 12    16 qt 9 10 11 12    24 qt 9 10 11 12
                                   13.                 14.                 14.                 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.
Fruits and vegetables 17 18 19..  $8.00 in cash-      $10.00 in cash-     $10.00 in cash-     $10.00 in cash-
                                   value vouchers.     value vouchers.     value vouchers.     value vouchers.
Whole wheat or whole grain bread  2 lb..............  1 lb..............  N/A...............  1 lb.
 \20\.
Fish (canned)...................  N/A...............  N/A...............  N/A...............  30 oz.
Legumes, dry \21\ and/or Peanut   1 lb..............  1 lb..............  1 lb..............  1 lb.
 butter.                          Or................  And...............  Or................  And.
                                  18 oz.............  18 oz.............  18 oz.............  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. The competent professional authority (CPA), as established by State agency policy, is
  authorized to determine nutritional risk and prescribe supplemental foods per medical documentation.
\2\ This food package is issued to two categories of WIC participants: Women participants with singleton
  pregnancies and breastfeeding women whose partially (mostly) breastfed infants receive formula from the WIC
  Program in amounts that do not exceed the maximum formula allowances as appropriate for the age of the infant
  as described in Table 1 of paragraph (e)(9) of this section.
\3\ This food package is issued to two categories of WIC participants: Non-breastfeeding postpartum women and
  breastfeeding postpartum women whose breastfed infants receive more than the maximum infant formula allowances
  as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section.
\4\ This food package is issued to four categories of WIC participants: Fully breastfeeding women whose infants
  do not receive formula from the WIC Program; women pregnant with two or more fetuses; women partially (mostly)
  breastfeeding multiple infants from the same pregnancy, and pregnant women who are also partially (mostly)
  breastfeeding singleton infants.
\5\ Women fully breastfeeding multiple infants from the same pregnancy 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 nutritionals.
\8\ Powder and ready-to-feed may be substituted at rates that provide comparable nutritive value.
\9\ Whole milk is the standard milk for issuance to 1-year-old children (12 through 23 months). Fat-reduced
  milks may be issued to 1-year old children as determined appropriate by the health care provider per medical
  documentation. Lowfat (1%) or nonfat milks are the standard milks for issuance for children >= 24 months of
  age and women. Whole milk or reduced fat (2%) milk may be substituted for lowfat (1%) or nonfat milk for
  children = 24 months of age and women as determined appropriate by the health care provider per
  medical documentation.
\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.
\11\ For children and women, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of
  milk. For children and women in the pregnant, partially breastfeeding and postpartum food packages, no more
  than 1 pound of cheese may be substituted. For women in the fully breastfeeding food package, no more than 2
  pounds of cheese may be substituted for milk. State agencies do not have the option to issue additional
  amounts of cheese beyond these maximums even with medical documentation. (No more than a total of 4 quarts of
  milk may be substituted for a combination of cheese, yogurt or tofu for children and women in the pregnant,
  partially breastfeeding and postpartum food packages. No more than a total of 6 quarts of milk may be
  substituted for a combination of cheese, yogurt or tofu for women in the fully breastfeeding food package.)

[[Page 12296]]

 
\12\ For children and women, yogurt may be substituted for fluid milk at the rate of 1 quart of yogurt per 1
  quart of milk; a maximum of 1 quart of milk can be substituted. Additional amounts of yogurt are not
  authorized. Whole yogurt is the standard yogurt for issuance to 1-year-old children (12 through 23 months).
  Lowfat or nonfat yogurt may be issued to 1-year-old children (12 months to 23 months) as determined
  appropriate by the health care provider per medical documentation. Lowfat or nonfat yogurts are the standard
  yogurt for issuance to children >= 24 months of age and women. Whole yogurt may be substituted for lowfat or
  nonfat yogurt for children >= 24 months of age and women as determined appropriate by the health care provider
  per medical documentation. (No more than a total of 4 quarts of milk may be substituted for a combination of
  cheese, yogurt or tofu for children and women in the pregnant, partially breastfeeding and postpartum food
  packages. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or
  tofu for women in the fully breastfeeding food package.)
\13\ For children, soy-based beverage and tofu may be substituted for milk as determined appropriate by the
  health care provider per medical documentation. Soy-based beverage may be substituted for milk on a quart for
  quart basis up to the total maximum allowance of milk. Tofu may be substituted for milk for children at the
  rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of milk may be substituted for
  a combination of cheese, yogurt or tofu for children.) Additional amounts of tofu may be substituted, up to
  the maximum allowance for fluid milk for children, as determined appropriate by the health care provider per
  medical documentation.
\14\ For women, soy-based beverage may be substituted for milk on a quart for quart basis up to the total
  maximum monthly allowance of milk. Tofu may be substituted for milk at the rate of 1 pound of tofu per 1 quart
  of milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or
  tofu for women in the pregnant, partially breastfeeding and postpartum food packages. No more than a total of
  6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in the fully
  breastfeeding food package.) Additional amounts of tofu may be substituted, up to the maximum allowances for
  fluid milk, as determined appropriate by the health care provider per medical documentation.
\15\ 32 dry ounces of infant cereal may be substituted for 36 ounces of breakfast cereal as determined
  appropriate by the health care provider per medical documentation.
\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\ Both fresh fruits and fresh vegetables must be authorized by State agencies. Processed fruits and
  vegetables, i.e., canned (shelf-stable), frozen, and/or dried fruits and vegetables may also be authorized to
  offer a wider variety and choice for participants. State agencies may choose to authorize one or more of the
  following processed fruits and vegetables: canned fruit, canned vegetables, frozen fruit, frozen vegetables,
  dried fruit, and/or dried vegetables. The cash-value voucher may be redeemed for any eligible fruit and
  vegetable (refer to Table 4 of paragraph (e)(12) of this section and its footnotes). Except as authorized in
  paragraph (b)(1)(i) of this section, State agencies may not selectively choose which fruits and vegetables are
  available to participants. For example, if a State agency chooses to offer dried fruits, it must authorize all
  WIC-eligible dried fruits.
\18\ Children and women whose special dietary needs require the use of pureed foods may receive commercial
  jarred infant food fruits and vegetables in lieu of the cash-value voucher. Children may receive 128 oz of
  commercial jarred infant food fruits and vegetables and women may receive 160 oz of commercial jarred infant
  food fruits and vegetables in lieu of the cash-value voucher. Infant food fruits and vegetables may be
  substituted for the cash-value voucher as determined appropriate by the health care provider per medical
  documentation.
\19\ The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as
  described in Sec.   246.16(j).
\20\ Whole wheat and/or whole grain bread must be authorized. State agencies have the option to also authorize
  brown rice, bulgur, oatmeal, whole-grain barley, whole wheat macaroni products, or soft corn or whole wheat
  tortillas on an equal weight basis.
\21\ Canned legumes may be substituted for dry legumes at the rate of 64 oz. (e.g., four 16-oz cans) of canned
  beans for 1 pound dry beans. In Food Packages V and VII, both beans and peanut butter must be provided.
  However, when individually tailoring Food Packages V or VII for nutritional reasons (e.g., food allergy,
  underweight, participant preference), State agencies have the option to authorize the following substitutions:
  1 pound dry and 64 oz. canned beans/peas (and no peanut butter); or 2 pounds dry or 128 oz. canned beans/peas
  (and no peanut butter); or 36 oz. peanut butter (and no beans).

    (12) Minimum requirements and specifications for supplemental 
foods. Table 4 describes the minimum requirements and specifications 
for supplemental foods in all food packages:

 Table 4--Minimum Requirements and Specifications for Supplemental Foods
------------------------------------------------------------------------
       Categories/foods         Minimum requirements and specifications
------------------------------------------------------------------------
WIC FORMULA:
    Infant formula...........  All authorized infant formulas must:
                               (1) Meet the definition for an infant
                                formula in section 201(z) of the Federal
                                Food, Drug, and Cosmetic Act (21 U.S.C.
                                321(z)) and meet the requirements for an
                                infant formula under section 412 of the
                                Federal Food, Drug and Cosmetic Act, as
                                amended (21 U.S.C. 350a) and the
                                regulations at 21 CFR parts 106 and 107;
                               (2) Be designed for enteral digestion via
                                an oral or tube feeding;
                               (3) Provide at least 10 mg iron per liter
                                (at least 1.5 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               Certain enteral products that are
     nutritionals.\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 nutritionals 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.
 
MILK AND MILK ALTERNATIVES:

[[Page 12297]]

 
  Cow's milk \2\.............  Must conform to FDA standard of identity
                                for whole, reduced fat, lowfat, or
                                nonfat milks (21 CFR 131.110). Must be
                                pasteurized. May be flavored or
                                unflavored. May be fluid, shelf-stable,
                                evaporated (21 CFR 131.130), or dry.
                               Dry whole milk must conform to FDA
                                standard of identity (21 CFR 131.147).
                                Nonfat dry milk must conform to FDA
                                standard of identity (21 CFR 131.127).
                               Cultured milks must conform to FDA
                                standard of identity for cultured milk,
                                e.g. cultured buttermilk, kefir cultured
                                milk, acidophilus cultured milk (21 CFR
                                131.112).
                               Acidified milk must conform to FDA
                                standard of identity for acidified milk,
                                e.g., acidified kefir milk, acidified
                                acidophilus milk or acidified buttermilk
                                (21 CFR 131.111).
                               All reduced fat, lowfat, and nonfat cow's
                                milk types and varieties must 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).
Goat's milk..................  Must be pasteurized. May be flavored or
                                unflavored. May be fluid, shelf-stable,
                                evaporated or dry (i.e., powdered).
                               All reduced fat, lowfat, and nonfat
                                goat's milk must 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).
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
                                process American, or blends of any of
                                these cheeses are authorized.
                               Cheeses that are labeled low, free,
                                reduced, less or light in sodium, fat or
                                cholesterol are WIC eligible.
Yogurt (cow's milk)..........  Yogurt must be pasteurized and conform to
                                FDA standard of identity for whole fat
                                (21 CFR 131.200), lowfat (21 CFR
                                131.203), or nonfat (21 CFR 131.206);
                                plain or flavored with <=40 g of total
                                sugars per 1 cup yogurt. Yogurts that
                                are fortified with vitamin A and D and
                                other nutrients may be allowed at the
                                State agency's option. Yogurts sold with
                                accompanying mix-in ingredients such as
                                granola, candy pieces, honey, nuts and
                                similar ingredients are not authorized.
                                Drinkable yogurts are not authorized.
Tofu.........................  Calcium-set tofu prepared with calcium
                                salts (e.g., calcium sulfate). May not
                                contain added fats, sugars, oils, or
                                sodium. Tofu must be calcium-set, i.e.,
                                contain calcium salts, but may also
                                contain other coagulants, i.e.,
                                magnesium chloride.
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.
                                May be flavored or unflavored.
JUICE........................  Must be pasteurized 100% unsweetened
                                fruit juice. Must contain at least 30 mg
                                of vitamin C per 100 mL of juice. Must
                                conform to FDA standard of identity as
                                appropriate (21 CFR part 146) or
                                vegetable juice must conform to FDA
                                standard of identity as appropriate (21
                                CFR part 156). With the exception of
                                100% 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. Blends
                                of authorized juices are allowed.
                               Vegetable juice may be regular or lower
                                in sodium.
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 (READY-TO-    Must contain a minimum of 28 mg iron per
 EAT AND INSTANT AND REGULAR    100 g dry cereal.
 HOT CEREALS).                 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''.\3\
FRUITS AND VEGETABLES (FRESH   Any variety of fresh (as defined by 21
 AND PROCESSED) 4 5 6 8 9.      CFR 101.95) whole or cut fruit without
                                added sugars.
                               Any variety of fresh (as defined by 21
                                CFR 101.95) whole or cut vegetable,
                                except white potatoes, without added
                                sugars, fats, or oils (orange yams and
                                sweet potatoes are allowed).
                               Any variety of canned fruits (must
                                conform to FDA standard of identity as
                                appropriate (21 CFR part 145));
                                including applesauce, juice pack or
                                water pack without added sugars, fats,
                                oils, or salt (i.e., sodium). The fruit
                                must be listed as the first ingredient.
                               Any variety of frozen fruits without
                                added sugars, fats, oils, or salt (i.e.,
                                sodium).
                               Any variety of canned or frozen
                                vegetables, except white potatoes
                                (orange yams and sweet potatoes are
                                allowed); without added sugars, fats, or
                                oils. Vegetable must be listed as the
                                first ingredient. May be regular or
                                lower in sodium. Must conform to FDA
                                standard of identity as appropriate (21
                                CFR part 155).
                               Any type of dried fruits or dried
                                vegetable, except white potatoes (orange
                                yams and sweet potatoes are allowed);
                                without added sugars, fats, oils, or
                                salt (i.e., sodium).
                               Any type of immature beans, peas, or
                                lentils, fresh or in canned \5\ forms.
                               Any type of frozen beans (immature or
                                mature). Beans purchased with the CVV
                                may contain added vegetables and fruits,
                                but may not contain added sugars, fats,
                                oils, or meat as purchased. Canned
                                beans, peas, or lentils may be regular
                                or lower in sodium content.
                               State agencies must allow organic forms
                                of WIC-eligible fruits and vegetables.
WHOLE WHEAT BREAD, WHOLE
 GRAIN BREAD, AND WHOLE GRAIN
 OPTIONS:
    Bread....................  Whole wheat bread must conform to FDA
                                standard of identity (21 CFR 136.180).
                                (Includes whole wheat buns and rolls.)
                                ``Whole wheat flour'' and/or ``bromated
                                whole wheat flour'' must be the only
                                flours listed in the ingredient list.

[[Page 12298]]

 
                               OR
                               Whole grain bread must conform to FDA
                                standard of identity (21 CFR 136.110)
                                (includes whole grain buns and rolls).
                               AND
                               Whole grain must be the primary
                                ingredient by weight in all whole grain
                                bread products.
                               AND
                               Must meet FDA labeling requirements for
                                making a health claim as a ``whole grain
                                food with moderate fat content''.\3\
    Whole Grain Options......  Brown rice, bulgur, oats, 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. Soft
                                corn tortillas made from ground masa
                                flour (corn flour) using traditional
                                processing methods are WIC-eligible,
                                e.g., whole corn, corn (masa), whole
                                ground corn, corn masa flour, masa
                                harina, and white corn flour. For whole
                                wheat tortillas, ``whole wheat flour''
                                must be the only flour listed in the
                                ingredient list.
                               Whole wheat macaroni products. Must
                                conform to FDA standard of identity (21
                                CFR 139.138) and have no added sugars,
                                fats, oils, or salt (i.e., sodium).
                                ``Whole wheat flour'' and/or ``whole
                                durum wheat flour'' must be the only
                                flours listed in the ingredient list.
                                Other shapes and sizes that otherwise
                                meet the FDA standard of identity for
                                whole wheat macaroni (pasta) products
                                (139.138), and have no added sugars,
                                fats, oils, or salt (i.e., sodium), are
                                also authorized (e.g., whole wheat
                                rotini, and whole wheat penne).
FISH (CANNED) \5\............  Canned only:
                               Light tuna (must conform to FDA standard
                                of identity (21 CFR 161.190));
                               Salmon (Pacific salmon must conform to
                                FDA standard of identity (21 CFR
                                161.170));
                               Sardines; and
                               Mackerel (N. Atlantic Scomber scombrus;
                                Chub Pacific Scomber japonicas; Jack
                                Mackerel \10\
                               May be packed in water or oil. Pack may
                                include bones or skin. Added sauces and
                                flavorings, e.g., tomato sauce, mustard,
                                lemon, are authorized at the State
                                agency's option. May be regular or lower
                                in sodium content.
MATURE LEGUMES (DRY BEANS AND  Any type of mature dry beans, peas, or
 PEAS) \7\.                     lentils in dry-packaged or canned \5\
                                forms. Examples include but are not
                                limited to black beans, black-eyed peas,
                                garbanzo beans (chickpeas), great
                                northern beans, white beans (navy and
                                pea beans), kidney beans, mature lima
                                (``butter beans''), fava and mung beans,
                                pinto beans, soybeans/edamame, split
                                peas, lentils, and refried beans. All
                                categories exclude soups. May not
                                contain added sugars, fats, oils,
                                vegetables, fruits or meat as purchased.
                                Canned legumes may be regular or lower
                                in sodium content.\11\
                               Baked beans may only be provided for
                                participants with limited cooking
                                facilities.\11\
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 forms are allowed. Peanut
                                butters with added marshmallows, honey,
                                jelly, chocolate or similar ingredients
                                are not authorized.
INFANT FOODS:
    Infant Cereal............  Infant cereal must contain a minimum of
                                45 mg of iron per 100 g of dry
                                cereal.\12\
    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. The fruit must be listed
                                as the first ingredient.\13\
    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. The vegetable
                                must be listed as the first
                                ingredient.\14\
    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.\15\
------------------------------------------------------------------------
Table 4 Footnotes: FDA = Food and Drug Administration of the U.S.
  Department of Health and Human Services.
\1\ The following are not considered a WIC-eligible nutritional:
  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 conform to FDA standards of identity for
  milks as defined by 21 CFR part 131 and meet WIC's requirements for
  vitamin fortification as specified in Table 4 of paragraph (e)(12) of
  this section. Additional authorized milks include, but are not limited
  to: calcium-fortified, lactose-reduced and lactose-free, organic 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\ FDA Health Claim Notification for Whole Grain Foods with Moderate
  Fat Content at http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073634.htm
\4\ Processed refers to frozen, canned,\5\ or dried.
\5\ ``Canned'' refers to processed food items in cans or other shelf-
  stable containers, e.g., jars, pouches.
\6\ The following are not authorized: herbs and spices; creamed
  vegetables or vegetables with added sauces; mixed vegetables
  containing noodles, nuts or sauce packets, vegetable-grain (pasta or
  rice) mixtures; fruit-nut mixtures; breaded vegetables; fruits and
  vegetables for purchase on salad bars; peanuts or other nuts;
  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; decorative blossoms and flowers,
  and foods containing fruits such as blueberry muffins and other baked
  goods. Home-canned and home-preserved fruits and vegetables are not
  authorized.
\7\ Mature legumes in dry-packed or canned forms may be purchased with
  the WIC food instrument only. Immature varieties of fresh or canned
  beans and frozen beans of any type (immature or mature) may be
  purchased with the cash-value voucher only. Juices are provided as
  separate food WIC categories and are not authorized under the fruit
  and vegetable category.
\8\ Excludes white potatoes, mixed vegetables containing white potatoes,
  dried white potatoes; catsup or other condiments; pickled vegetables;
  olives; soups; juices; and fruit leathers and fruit roll-ups. Canned
  tomato sauce, tomato paste, salsa and spaghetti sauce without added
  sugar, fats, or oils are authorized.
\9\ State agencies have the option to allow only lower sodium canned
  vegetables for purchase with the cash-value voucher.
\10\ FDA defines jack mackerel as any of the following six species:
  Trachurus declivis, trachurus japonicas, trachurur symmetricus,
  trachurus murphyi, trachurus novaezelandiae, and trachurus lathami in
  The Seafood List at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm113260.htm. King
  mackerel is not authorized.

[[Page 12299]]

 
\11\ The following are not authorized in the mature legume category:
  soups; immature varieties of legumes, such as those used in canned
  green peas, green beans, snap beans, yellow 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, oils, meats,
  fruits or vegetables.
\12\ Infant cereals containing infant formula, milk, fruit, or other non-
  cereal ingredients are not allowed.
\13\ Mixtures with cereal or infant food desserts (e.g., peach cobbler)
  are not authorized; however, combinations of single ingredients (e.g.,
  apple-banana) and combinations of single ingredients of fruits and/or
  vegetables (e.g., apples and squash) are allowed.
\14\ Combinations of single ingredients (e.g., peas and carrots) and
  combinations of single ingredients of fruits and/or vegetables (e.g.,
  apples and squash) are allowed. Mixed vegetables with white potato as
  an ingredient (e.g., mixed vegetables) are authorized. Infant foods
  containing white potatoes as the primary ingredient are not
  authorized.
\15\ No infant food combinations (e.g., meat and vegetables) or dinners
  (e.g., spaghetti and meatballs) are allowed.

0
5. In Sec.  246.12:
0
a. Remove the phrase ``WIC-eligible medical foods'' and add in its 
place ``WIC-eligible nutritionals'' wherever it appears;
0
b. Amend paragraph (a)(1) by removing the words ``and farmers'' after 
``vendors'' in the second sentence and adding in their place the phrase 
``, farmers and farmers' markets,'';
0
c. Amend paragraphs (f)(2)(ii) and (f)(2)(iv) by removing the word 
``vouchermay'' and adding in its place the words ``voucher may'' 
whenever it appears in these paragraphs;
0
d. Add a new paragraph (f)(4);
0
e. Amend paragraph (g)(3)(i) by removing the words ``varieties of'' in 
both places that it appears in the second sentence and adding in their 
place the word ``different'';
0
f. Amend paragraph (h)(3)(i) by removing the word ``vouchersonly'' and 
adding in its place the words ``vouchers only'';
0
g. Amend paragraph (h)(3)(vii) by adding the words ``, or cash-value 
vouchers'' after the word ``instruments'';
0
h. Revise the heading and the first two sentences of paragraph 
(h)(3)(viii);
0
i. Amend paragraph (h)(3)(x) by removing the last sentence of the 
paragraph;
0
j. Redesignate paragraphs (h)(3)(xi) through (h)(3)(xxv) as paragraphs 
(h)(3)(xii) through (h)(3)(xxvi) and add a new paragraph (h)(3)(xi);
0
k. Amend paragraph (l)(1)(ii)(A) by adding the words ``, or cash-value 
vouchers,'' after the word ``instruments'';
0
l. Revise paragraph (o);
0
m. Amend paragraphs (r)(3) and (t) by adding the phrase ``, farmers' 
markets,'' after the word ``farmer'';
0
n. Amend paragraph (u)(5) by adding the words ``, farmers, farmers' 
markets,'' after the word ``contractors'';
0
o. Revise the heading and introductory text of paragraph (v);
0
p. Amend paragraph (v)(1) by adding the words ``or farmers' market'' 
after the word ``farmer'';
0
q. Revise paragraph (v)(1)(iv);
0
r. Amend paragraphs (v)(2) through (v)(6) by adding the words ``or 
farmers' market'' after the word ``farmer'' wherever it occurs;
0
s. Revise paragraph (v)(3);
0
t. Redesignate paragraphs (v)(4) through (v)(6) as paragraphs (v)(5) 
through (v)(7), and add a new paragraph (v)(4); and
0
u. Add a new paragraph (v)(8).
    The revisions and additions read as follows:


Sec.  246.12  Food delivery systems.

* * * * *
    (f) * * *
    (4) Split tender transactions. The State agency must implement 
procedures that allow the participant, authorized representative or 
proxy to pay the difference when a fruit and vegetable purchase exceeds 
the value of the cash-value vouchers.
* * * * *
    (h) * * *
    (3) * * *
    (viii) Food instrument and cash-value voucher redemption. The 
vendor must submit food instruments and cash-value vouchers for 
redemption in accordance with the redemption procedures described in 
the vendor agreement. The vendor may redeem a food instrument or cash-
value voucher only within the specified time period. * * *
    (xi) Split tender for cash-value vouchers. The vendor must allow 
the participant, authorized representative or proxy to pay the 
difference when a fruit and vegetable purchase exceeds the value of the 
cash-value vouchers (also known as a split tender transaction).
* * * * *
    (o) Participant parent/caretaker, proxy, vendor, farmer, farmers' 
market, 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, farmers' markets, home food delivery 
contractors, and direct distribution contractors. Complaints of civil 
rights discrimination must be handled in accordance with Sec.  
246.8(b).
* * * * *
    (v) Farmers and farmers' markets. The State agency may authorize 
farmers, farmers' markets, and/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 and/or 
farmers' markets. The agreement must be signed by a representative who 
has legal authority to obligate the farmer or farmers' market and a 
representative of the State agency. The agreement must be for a period 
not to exceed 3 years. Only farmers or farmers' markets authorized by 
the State agency may redeem the fruit and vegetable cash-value voucher. 
The State agency must require farmers or farmers' markets to reapply at 
the expiration of their agreements and must provide farmers or farmers 
markets with not less than 15 days advance written notice of the 
expiration of the agreement.
* * * * *
    (1) * * *
    (iv) Redeem the cash-value voucher in accordance with a procedure 
established by the State agency. Such procedure must include a 
requirement for the farmer or farmers' market to allow the participant, 
authorized representative or proxy to pay the difference when the 
purchase of fruits and vegetables exceeds the value of the cash-value 
vouchers (also known as a split tender transaction);
* * * * *
    (3) Neither the State agency nor the farmer or farmers' market has 
an obligation to renew the agreement. The State agency, the farmer, or 
farmers' market may terminate the agreement for cause after providing 
advance written notification.
    (4) Farmer agreements for State agencies that do not authorize 
farmers. Those State agencies which authorize farmers' markets but not 
individual farmers shall require authorized farmers' markets to enter 
into a written agreement with each farmer within the market that is 
authorized to accept cash-value vouchers. The State agency shall set 
forth the required terms for the written agreement as defined in Sec.  
246.12(v)(1) and (v)(2), and provide a sample agreement for use by the 
farmers' market.
* * * * *
    (8) Monitoring farmers and farmers' markets.--(i) The State agency 
must design and implement a system for monitoring its authorized 
farmers and farmers' markets for compliance with

[[Page 12300]]

program requirements. The State agency must document, at a minimum, the 
following information for all monitoring visits: name(s) of the farmer, 
farmers market, or roadside stand; name(s) and signature(s) of the 
reviewer(s); date of review; and nature of problem(s) detected.
    (ii) Compliance buys. For compliance buys, the State agency must 
also document:
    (A) The date of the buy;
    (B) A description of the farmer (and farmers' market, as 
appropriate) involved in each transaction;
    (C) The types and quantities of items purchased, current retail 
prices or prices charged other customers, and price charged for each 
item purchased, if available. Price information may be obtained prior 
to, during, or subsequent to the compliance buy; and
    (D) The final disposition of all items as destroyed, donated, 
provided to other authorities, or kept as evidence.
0
6. In Sec.  246.16, revise paragraph (j)(2) to read as follows:


Sec.  246.16  Distribution of funds.

* * * * *
    (j) * * *
    (2) Base value of the fruit and vegetable voucher. The base year 
for calculation of the value of the fruit and vegetable voucher is 
fiscal year 2008. The base value to be used equals:
    (i) $8 for children; and
    (ii) $10 for women.
* * * * *
0
7. In Sec.  246.18:
0
a. Revise paragraph (a)(4);
0
b. Amend paragraphs (b), (d), (e), and (f) by adding the phrase ``or 
farmers' market'' after the word ``farmer'' whenever it appears;
0
c. Revise the first sentence in paragraph (b)(9);
0
d. Amend paragraph (c) introductory text by adding the phrase ``, 
farmer, or farmers' market'' after the word ``vendor'' in the last 
sentence; and
0
e. Revise paragraph (c)(2);
    The revisions and additions read as follows:


Sec.  246.18  Administrative review of State agency actions.

    (a) * * *
    (4) Farmer or farmers' market appeals.--(i) Adverse actions. The 
State agency shall provide a hearing procedure whereby farmers or 
farmers' markets adversely affected by certain actions of the State 
agency may appeal those actions. A farmer or farmers' market 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 or farmers' 
markets. 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. The State agency must make all other adverse 
actions effective no earlier than 15 days after the date of the notice 
of 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 an administrative review, no later than the date the farmer 
or farmers' market receives the review decision.
    (b) * * *
    (9) Written notification of the review decision, including the 
basis for the decision, within 90 days from the date of receipt of the 
request for an administrative review from a vendor, farmer, or farmer's 
market, and within 60 days from the date of receipt of a local agency's 
request for an administrative review. * * *
    (c) * * *
    (2) A decision-maker who is someone other than the person who 
rendered the initial decision on the action and whose determination is 
based solely on whether the State agency has correctly applied Federal 
and State statutes, regulations, policies, and procedures governing the 
Program, according to the information provided to the vendor, farmer, 
or farmers' market concerning the cause(s) for the adverse action and 
the response from the vendor, farmer, or farmers' market.
* * * * *
0
8. In Sec.  246.23:
0
a. Amend paragraph (a)(1) by removing the words ``or food instruments'' 
and by adding in its place the phrase ``food instruments, or cash-value 
vouchers''; and
0
b. Revise paragraph (a)(2).
    The revisions read as follows:


Sec.  246.23  Claims and penalties.

    (a) * * *
    (2) If FNS determines that any part of the Program funds received 
by a State agency; or supplemental foods, either purchased or donated 
commodities; or food instruments or cash-value vouchers, were lost as a 
result of thefts, embezzlements, or unexplained causes, the State 
agency shall, on demand by FNS, pay to FNS a sum equal to the amount of 
the money or the value of the supplemental foods, food instruments, or 
cash-value vouchers so lost.
* * * * *

    Dated: February 20, 2014.
Janey Thornton,
Acting Under Secretary, Food, Nutrition, and Consumer Services.
[FR Doc. 2014-04105 Filed 2-28-14; 8:45 am]
BILLING CODE 3410-30-P