[Code of Federal Regulations]
[Title 7, Volume 4]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR246.10]

[Page 370-378]
 
                          TITLE 7--AGRICULTURE
 
    CHAPTER II--FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE
 
PART 246_SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND 
 
                     Subpart D_Participant Benefits
 
Sec. 246.10  Supplemental foods.


    (a) General. This section prescribes the requirements for providing 
supplemental foods to participants.
    (b) State agency responsibilities. State agencies shall--
    (1) Identify foods which are acceptable for use under the Program in 
accordance with the requirements of this

[[Page 371]]

section and provide to local agencies a list of acceptable foods and 
their maximum monthly quantities as specified in paragraph (c) of this 
section; and
    (2) Ensure that local agencies--
    (i) Make available at least one food from each group in each food 
package listed in paragraph (c) of this section. However, this does not 
mean that the local agency must provide each participant with a food 
from each food group;
    (ii) Make available to participants the supplemental foods, as 
authorized in paragraph (c) of this section; and
    (iii) Designate a competent professional authority to prescribe 
types of supplemental foods in quantities appropriate for each 
participant, taking into consideration the participant's age and dietary 
needs. The amounts of supplemental foods shall not exceed the maximum 
quantities specified in this section.
    (c) Food packages. There are seven food packages available under the 
Program which may be provided to participants. The authorized 
supplemental foods shall be prescribed from food packages according to 
the category and nutritional need of the participant. The food packages 
are as follows:
    Note: The metric units given are mathematical conversions. If 
packaging practices change, the authorized food quantities will be 
revised accordingly.
    (1) Food Package I--Infants 0 Through 3 Months. (i) Iron-fortified 
infant formula--requirements and routine issuance. Except as specified 
in paragraphs (c)(1)(iii) through (c)(1)(v) of this section, local 
agencies must issue a contract brand infant formula that meets the 
requirements of paragraph (c)(1)(i) of this section. The supplemental 
food for this food package is an iron-fortified infant formula that is 
not an exempt infant formula. The iron-fortified infant formula must be 
nutritionally complete, not requiring the addition of any ingredients 
other than water prior to being served in a liquid state. It also must 
contain at least 10 milligrams of iron per liter at standard dilution 
and supply 67 kilocalories per 100 milliliters (i.e., approximately 20 
kilocalories per fluid ounce of infant formula) at standard dilution. 
Medical documentation is not required for any contract brand infant 
formula authorized for issuance by the State agency, including the soy-
based contract brand of infant formula. However, the State agency may 
require medical documentation for any contract brand infant formula even 
though it meets these requirements and may decide that some contract 
brand infant formulas may not be issued under any circumstances.
    (ii) Physical forms. Local agencies must issue all WIC formulas (WIC 
formula means all infant formulas, including exempt infant formulas, and 
WIC-eligible medical foods) in concentrated liquid or powdered physical 
forms. Ready-to-feed WIC formulas may be authorized when the competent 
professional authority determines and documents that the participant's 
household has an unsanitary or restricted water supply or poor 
refrigeration, the participant or person caring for the participant may 
have difficulty in correctly diluting concentrated forms or 
reconstituting powdered forms, or the WIC formula is only available in 
ready-to-feed form.
    (iii) WIC formulas requiring medical documentation. Local agencies 
may issue the following WIC formulas, but only with medical 
documentation:
    (A) Any contract brand infant formula that does not meet the 
requirements of paragraph (c)(1)(i) of this section (e.g., low-iron, 
low-calorie, or high-calorie infant formulas);
    (B) Any non-contract brand infant formula (even if it meets the 
requirements for an iron-fortified infant formula in paragraph (c)(1)(i) 
of this section);
    (C) Any exempt infant formula; and
    (D) Any WIC-eligible medical food.
    (iv) Religious eating patterns exception. Local agencies may issue a 
non-contract brand infant formula that meets the requirements of 
paragraph (c)(1)(i) of this section without medical documentation in 
order to meet religious eating patterns. However, if the non-contract 
brand infant formula does not meet the requirements of paragraph 
(c)(1)(i) of this section, medical documentation must be provided. 
Documentation of the basis of the substitution must be kept on file at 
the local clinic.
    (v) Medical documentation. (A) Determination. For purposes of this 
food

[[Page 372]]

package, medical documentation means a determination by a licensed 
health care professional authorized to write medical prescriptions under 
State law. A licensed health care professional must make a medical 
determination that an infant has a medical condition that dictates the 
use of the following: a contract brand infant formula that does not meet 
the requirements of paragraph (c)(1)(i) of this section; a non-contract 
brand infant formula; an exempt infant formula; or a WIC-eligible 
medical food. These conditions include, but are not limited to: those 
that contraindicate the use of iron-fortified infant formula, metabolic 
disorders, inborn errors of amino acid metabolism, gastrointestinal 
disorders, malabsorption syndromes, and food allergies. Low-calorie WIC 
formulas may not be issued solely for the purpose of managing body 
weight.
    (B) Technical requirements. Medical documentation must include the 
brand name of the WIC formula prescribed; medical diagnosis warranting 
the issuance of WIC formula; length of time the prescribed WIC formula 
is medically required by the participant; and signature or name (if the 
initial medical documentation was received by telephone) of the 
requesting health care professional. Medical documentation may be 
provided as an original written document, electronically, or by 
facsimile. Medical documentation also may be provided by telephone to a 
competent professional authority who must promptly document the 
information which must be kept on file at the local clinic. However, 
this method may only be used until written confirmation is received and 
only when absolutely necessary on an individual participant basis to 
prevent undue hardship to a participant or to prevent a delay in the 
provision of infant formula that would place the participant at 
increased nutritional risk. The local clinic must obtain written 
confirmation of the medical documentation within a reasonable amount of 
time (i.e., one or two weeks' time) after accepting the initial medical 
documentation by telephone. The written documentation must be kept on 
file with the initial telephone documentation.
    (vi) Quantities and types of supplemental foods. The quantities and 
types of supplemental foods prescribed shall be appropriate for the 
participant taking into consideration the participant's age and dietary 
needs. The maximum quantity of supplemental foods authorized per month 
is as follows:

------------------------------------------------------------------------
                 Food                               Quantity
------------------------------------------------------------------------
Formula:
  Concentrated liquid formula.........  403 fluid oz. (11.9 L).
        or
  Powdered formula....................  May be substituted at the rate
                                         of 8 lbs. (3.6 kg) per 403
                                         fluid oz. (11.9 L) of
                                         concentrated liquid formula.
        or
  Ready-to-feed formula...............  May be substituted at the rate
                                         of 26 fluid oz. (.8 L) per 13
                                         fluid oz. (.4 L) of
                                         concentrated liquid formula.
------------------------------------------------------------------------

    (2) Food Package II--Infants 4 through 12 Months. (i) Infant formula 
as specified in paragraphs (c)(1)(i) through (c)(1)(v) of this section.
    (ii) Infant cereal which contains a minimum of 45 milligrams of iron 
per 100 grams of dry cereal.
    (iii) Single strength fruit juice which contains a minimum of 30 
milligrams of vitamin C per 100 milliliters; or frozen concentrated 
fruit juice which contains a minimum of 30 milligrams of vitamin C per 
100 milliliters of reconstituted juice; or infant juice which contains a 
minimum of 30 milligrams of vitamin C per 100 milliliters. Issuance 
prior to the time when the infant can drink from a cup is discouraged. 
The competent professional authority shall instruct the participant's 
parent or guardian to feed the juice to the participant from a cup to 
prevent ``bottle caries.''
    (iv) The quantities and types of supplemental foods prescribed shall 
be appropriate for the participant taking into consideration the 
participant's age and dietary needs. The maximum quantity of 
supplemental foods authorized per month is as follows:

------------------------------------------------------------------------
                 Food                               Quantity
------------------------------------------------------------------------
Formula:
  Concentrated liquid formula.........  403 fluid oz. (11.9 L).
        or
  Powdered formula....................  May be substituted at the rate
                                         of 8 lb. (3.6 kg) per 403 fluid
                                         oz. (11.9 L) of concentrated
                                         liquid formula.

[[Page 373]]


        or
  Ready-to-feed formula...............  May be substituted at the rate
                                         of 26 fluid oz. (.8 L) per 13
                                         fluid oz. (.4 L) of
                                         concentrated liquid formula.
Infant cereal.........................  24 oz. dry (.7 kg).
Juice: \1\
  Single strength adult juice.........  92 fluid oz. (2.7 L).
        or
  Frozen concentrated juice...........  96 fluid oz. reconstituted (2.8
                                         L).
        or
  Infant juice........................  May be substituted at the rate
                                         of 63 fluid oz. (1.9 L) of
                                         infant juice per 92 fluid oz.
                                         (2.7 L) of single strength
                                         adult juice.
------------------------------------------------------------------------
\1\ Combinations of single strength or frozen concentrated juice may be
  issued as long as the total volume of juice does not exceed the amount
  specified for single strength juice.

    (3) Food Package III--Children/Women with Special Dietary Needs. 
Local agencies may issue this food package to women and children only 
with medical documentation. The supplemental foods in Food Package III 
are set forth in paragraphs (c)(3)(i) through (c)(3)(iv) of this 
section. For purposes of this food package, medical documentation means 
a determination by a licensed health care professional authorized to 
write medical prescriptions under State law that the child or woman has 
a medical condition that dictates the use of a WIC formula (WIC formula 
means all infant formulas, including exempt infant formulas, and WIC-
eligible medical foods) because the use of conventional foods is 
precluded or restricted. These medical conditions include, but are not 
limited to, metabolic disorders, inborn errors of amino acid metabolism, 
gastrointestinal disorders, malabsorption syndromes and food allergies. 
This food package may not be issued solely for the purpose of enhancing 
nutrient intake or managing body weight. Medical documentation for WIC 
formulas must meet the technical requirements described in paragraph 
(c)(1)(v)(B) of this section.
    (i) WIC formulas (i.e., an infant formula, exempt infant formula, or 
WIC-eligible medical food).
    (ii) Cereal (hot or cold) which contains a minimum of 28 milligrams 
of iron per 100 grams of dry cereal and not more than 21.2 grams of 
sucrose and other sugars per 100 grams of dry cereal (6 grams per 
ounce).
    (iii) Single strength fruit juice or vegetable juice, or both, which 
contains a minimum of 30 milligrams of vitamin C per 100 milliliters; or 
frozen concentrated fruit or vegetable juice, or both, which contains a 
minimum of 30 milligrams of vitiamin C per 100 milliliters of 
reconstituted juice.
    (iv) The quantities and types of supplemental foods prescribed shall 
be appropriate for the participant taking into consideration the 
participant's age and special dietary needs. The maximum quantity of 
supplemental foods authorized per month is as follows:

------------------------------------------------------------------------
                 Food                               Quantity
------------------------------------------------------------------------
Formula:
  Concentrated liquid formula.........  403 fluid oz. (11.9 L).
  Addition \1\........................  52 fluid oz. (1.5 L).
        or
  Powdered formula....................  May be substituted at a rate of
                                         8 lb. (3.6 kg) per 403 fluid
                                         oz. (11.9 L) of concentrated
                                         liquid formula.
  Addition \1\........................  1 lb. (.4 kg).
        or
  Ready-to-feed formula...............  May be substituted at the rate
                                         of 26 fluid oz. (.8 L) per 13
                                         fluid oz. (.4 L) of
                                         concentrated liquid formula.
  Addition \1\........................  104 fluid oz. (3.1 L).
Cereal (hot or cold)..................  36 oz. dry (1 kg).
Juice: \2\
  Single strength juice...............  138 fluid oz. (4.1 L).
        or
  Frozen concentrated juice...........  144 fluid oz. reconstituted (4.3
                                         L).
------------------------------------------------------------------------
\1\ Additional formula may be issued on an individual basis provided the
  need is demonstrated and documented in the individual's certification
  file by the competent professional authority.
\2\ Combinations of single strength and frozen concentrated juice may be
  issued as long as the total volume does not exceed the amount
  specified for single strength juice.

    (4) Food Package IV--Children 1 to 5 Years. (i) Pasteurized fluid 
whole milk which is flavored or unflavored and which contains 400 
International Units of vitamin D per quart (.9 liter); or pasteurized 
fluid skim or lowfat milk which is flavored or unflavored and which 
contains 400 International Units of vitamin D and 2000 International 
Units of vitamin A per fluid quart (.9 liter); or pasteurized cultured 
buttermilk which contains 400 International units of vitamin D and 2000 
International Units of vitamin A per fluid quart (.9 liter); or 
evaporated whole milk which contains 400 International Units of vitamin 
D per reconstituted quart (.9 liter); or evaporated skimmed milk which 
contains 400 International Units of vitamin D and 2000 International 
Units of vitamin A per reconstituted quart (.9 liter); or dry whole

[[Page 374]]

milk which contains 400 International Units of vitamin D per 
reconstituted quart (.9 liter); or nonfat or lowfat dry milk which 
contains 400 International Units of vitamin D and 2000 International 
Units of vitamin A per reconstituted quart (.9 liter); or domestic 
cheese (pasteurized process American, Monterey Jack, Colby, natural 
Cheddar, Swiss, Brick, Muenster, Provolone, Mozzarella Part-Skim or 
Whole).
    (ii) Adult cereal (hot or cold) which contains a minimum of 28 
milligrams of iron per 100 grams of dry cereal and not more than 21.2 
grams of sucrose and other sugars per 100 grams of dry cereal (6 grams 
per ounce).
    (iii) Single strength fruit juice or vegetable juice, or both, which 
contains a minimum of 30 milligrams of vitamin C per 100 milliliters; or 
frozen concentrated fruit or vegetable juice, or both, which contains a 
minimum of 30 milligrams of vitamin C per 100 milliliters of 
reconstituted juice.
    (iv) Eggs or dried egg mix.
    (v) Peanut butter or mature dry beans or peas, including but not 
limited to, lentils, black, navy, kidney, garbanzo, soy, pinto, and mung 
beans, crowder, cow, split and black-eyed peas.
    (vi) The quantities and types of supplemental foods prescribed shall 
be appropriate for the participant taking into consideration the 
participant's age and dietary needs. The maximum quantity of 
supplemental foods authorized per month is as follows:

------------------------------------------------------------------------
                 Food                               Quantity
------------------------------------------------------------------------
Milk:
  Fluid whole milk....................  24 qt. (22.7 L).
        or
  Fluid skim or low fat milk..........  May be substituted for fluid
                                         whole milk on a quart-for-quart
                                         (.9 L) basis.
        or
  Cultured buttermilk.................  May be substituted for fluid
                                         whole milk on a quart-for-quart
                                         (.9 L) basis.
        or
  Evaporated whole milk...............  May be substituted for fluid
                                         whole milk at the rate of 13
                                         fluid oz. (.4 L) per qt. (.9 L)
                                         of fluid whole milk.
        or
  Evaporated skimmed milk.............  May be substituted for fluid
                                         whole milk at the rate of 13
                                         fluid oz. (.4 L) per qt. (.9 L)
                                         of fluid whole milk.
        or
  Dry whole milk......................  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 3 qt. (2.8 L) of
                                         fluid whole milk.
        or
  Nonfat or lowfat dry milk...........  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 5 qt. (4.7 L) of
                                         fluid whole milk.
        or
  Cheese..............................  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 3 qt. (2.8 L) of
                                         fluid whole milk. 4 lbs. (1.8
                                         kg) is the maximum amount which
                                         may be substituted. \1\
Eggs:
  Eggs................................  2 doz. or 2\1/2\ doz.
        or
  Dried egg mix.......................  May be substituted at the rate
                                         of 1.5 lb. (.7 kg) egg mix per
                                         2 doz. fresh eggs or 2 lb. (.9
                                         kg) egg mix per 2\1/2\ doz.
                                         fresh eggs.
Cereals (hot or cold).................  36 oz. dry (1 kg).
Juice:\2\
  Single strength juice...............  276 fluid oz. (8.2 L).
        or
  Frozen concentrated juice...........  288 fluid oz. reconstituted (8.5
                                         L).
Legumes:
  Dry beans or peas...................  1 lb. (.4 kg).
        or
  Peanut butter.......................  18 oz. (.5 kg).
------------------------------------------------------------------------
\1\ Additional cheese may be issued on an individual basis in cases of
  lactose intolerance, provided the need is documented in the
  participant's file by the competent professional authority.
\2\ Combinations of single strength and frozen concentrated juice may be
  issued as long as the total volume does not exceed the amount
  specified for single strength juice.

    (5) Food Package V--Pregnant and Breastfeeding Women (Basic). (i) 
Pasteurized fluid whole milk which is flavored or unflavored and which 
contains 400 International Units of Vitamin D per quart (.9 liter) or 
pasteurized fluid skim or lowfat milk which is flavored or unflavored 
and which contains 400 International Units of vitamin D and 2000 
International Units of vitamin A per fluid quart (.9 liter); or 
pasteurized cultured buttermilk which contains 400 International Units 
of vitamin D and 2000 International Units of vitamin A per fluid quart 
(.9 liter); or evaporated whole milk which contains 400 International 
Units of vitamin D per reconstituted quart (.9 liter); or evaporated 
skimmed milk which contains 400 International Units of vitamin D and 
2000 International Units of vitamin A per reconstituted quart (.9 
liter); or dry whole milk which contains 400 International Units of 
vitamin D per reconstituted quart (.9 liter); or nonfat or lowfat dry 
milk which contains 400 International Units of vitamin D and 2000 
International Units of vitamin A per reconstituted quart (.9 liter); or 
domestic cheese (pasteurized process

[[Page 375]]

American, Monterey Jack, Colby, natural Cheddar, Swiss, Brick, Muenster, 
Provolone, Mozzarella Part-Skim or Whole).
    (ii) Adult cereal (hot or cold) which contains a minimum of 28 
milligrams of iron per 100 grams of dry cereal and not more than 21.2 
grams of sucrose and other sugars per 100 grams of dry cereal (6 grams 
per ounce).
    (iii) Single strength fruit juice or vegetable juice, or both, which 
contains a minimum of 30 milligrams of vitamin C per 100 milliliters; or 
frozen concentrated fruit or vegetable juice, or both, which contains a 
minimum of 30 milligrams of vitamin C per 100 milliliters of 
reconstituted juice.
    (iv) Eggs or dried egg mix.
    (v) Peanut butter or mature dry beans or peas, including but not 
limited to lentils, black, navy, kidney, garbanzo, soy, pinto and mung 
beans, crowder, cow, split and black-eyed peas.
    (vi) The quantities and types of supplemental foods prescribed shall 
be appropriate for the participant taking into consideration the 
participant's age and dietary needs. The maximum quantity of 
supplemental foods authorized per month is as follows:

------------------------------------------------------------------------
                 Food                               Quantity
------------------------------------------------------------------------
Milk:
  Fluid whole milk....................  28 qt. (26.5 L).
        or
  Fluid skim or lowfat milk...........  May be substituted for fluid
                                         whole milk on a quart-for-quart
                                         (.9 L) basis.
        or
  Cultured buttermilk.................  May be substituted for fluid
                                         whole milk on a quart-for-quart
                                         (.9 L) basis.
        or
  Evaporated whole milk...............  May be substituted for fluid
                                         whole milk at the rate of 13
                                         fluid oz. (.4 L) per qt. (.9 L)
                                         of fluid whole milk.
        or
  Evaporated skimmed milk.............  May be substituted for fluid
                                         whole milk at the rate of 13
                                         fluid oz. (.4 L) per qt. (.9 L)
                                         of fluid whole milk.
        or
  Dry whole milk......................  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 3 qt. (2.8 L) of
                                         fluid whole milk.
        or
  Nonfat or lowfat dry milk...........  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 5 qt. (4.7 L) of
                                         fluid whole milk.
        or
  Cheese..............................  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 3 qt. (2.8 L) of
                                         fluid whole milk. 4 lbs. (1.8
                                         kg) is the maximum amount which
                                         may be substituted.\1\
Eggs:
  Eggs................................  2 doz. or 2\1/2\ doz.
        or
  Dried egg mix.......................  May be substituted at the rate
                                         of 1.5 lb. (.7 kg) egg mix per
                                         2 doz. fresh eggs, or 2 lb. (.9
                                         kg) egg mix per 2\1/2\ doz.
                                         fresh eggs.
Cereals (hot or cold).................  36 oz. dry (1 kg).
Juice:\2\
  Single strength juice...............  276 fluid oz. (8.2 L).
        or
  Frozen, concentrated juice..........  288 fluid oz. reconstituted (8.5
                                         L).
Legumes:
  Dry beans or peas...................  1 lb. (.4 kg).
        or
  Peanut butter.......................  18 oz. (.5 kg).
------------------------------------------------------------------------
\1\ Additional cheese may be issued on an individual basis in cases of
  lactose intolerance, provided the need is documented in the
  participant's file by the competent professional authority.
\2\ Combinations of single strength or frozen concentrated juice may be
  issued as long as the total volume does not exceed the amount
  specified for single strength juice.

    (6) Food Package VI--Non-breastfeeding Postpartum Women. (i) 
Pasteurized fluid whole milk which is flavored or unflavored and which 
contains 400 International Units of vitamin D per quart (.9 liter); or 
pasteurized fluid skim or lowfat milk which is flavored or unflavored 
and which contains 400 International Units of vitamin D and 2000 
International Units of vitamin A per fluid quart (.9 liter); or 
pasteurized cultured buttermilk which contains 400 International Units 
of vitamin D and 2000 International Units of vitamin A per fluid quart 
(.9 liter); or evaporated whole milk which contains 400 International 
Units of vitamin D per reconstituted quart (.9 liter); or evaporated 
skimmed milk which contains 400 International Units of vitamin D and 
2000 International Units of vitamin A per reconstituted quart (.9 
liter); or dry whole milk which contains 400 International Units of 
vitamin D per reconstituted quart (.9 liter); or nonfat or lowfat dry 
milk which contains 400 International Units of Vitamin D and 2000 
International Units of vitamin A per reconstituted quart (.9 liter); or 
domestic cheese (pasteurized process American, Monterey Jack, Colby, 
natural Cheddar, Swiss, Brick, Muenster,

[[Page 376]]

Provolone, Mozzarella Part-Skim or Whole).
    (ii) Cereal (hot or cold) which contains a minimum of 28 milligrams 
of iron per 100 grams of dry cereal and not more than 21.1 grams of 
sucrose and other sugars per 100 grams of dry cereal (6 grams per 1 
ounce).
    (iii) Single strength fruit juice or vegetable juice, or both, which 
contains a minimum of 30 milligrams of vitamin C per 100 milliliters; or 
concentrated fruit or vegetable juice, or both, which contains a minimum 
of 30 milligrams of vitamin C per 100 milliliters of reconstituted 
juice.
    (iv) Eggs or dried egg mix.
    (v) The quantities and types of supplemental foods prescribed shall 
be appropriate for the participant taking into consideration the 
participant's age and dietary needs. The maximum quantity of 
supplemental foods authorized per month is as follows:

------------------------------------------------------------------------
                 Food                               Quantity
------------------------------------------------------------------------
Milk:
  Fluid whole milk....................  24 qt. (22.7 L).
        or
  Fluid skim or lowfat milk...........  May be substituted for fluid
                                         whole milk on a quart-for-quart
                                         (.9 L ) basis.
        or
  Cultured buttermilk.................  May be substituted for fluid
                                         whole milk on a quart-for-quart
                                         (.9 L) basis.
        or
  Evaporated whole milk...............  May be substituted for fluid
                                         whole milk at the rate of 13
                                         fluid oz. (.4 L) per qt. (.9 L)
                                         of fluid whole milk.
        or
  Evaporated skimmed milk.............  May be substituted for fluid
                                         whole milk at the rate of 13
                                         fluid oz. (.4 L) per qt. (.9 L)
                                         of fluid whole milk.
        or
  Dry whole milk......................  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 3 qt. (2.8 L) of
                                         fluid whole milk.
        or
  Nonfat or lowfat dry milk...........  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 5 qt. (4.7 L) of
                                         fluid whole milk.
        or
  Cheese..............................  May be substituted for fluid
                                         whole milk at the rate of 1 lb.
                                         (.4 kg) per 3 qt. (2.8 L) of
                                         fluid whole milk. 4 lbs. (1.8
                                         kg) is the maximum amount which
                                         may be substituted.\1\
Eggs:
  Eggs................................  2 doz. or 2\1/2\ doz.
        or
  Dried egg mix.......................  May be substituted at the rate
                                         of 1.5 lb. (.7 kg) egg mix per
                                         2 doz. fresh eggs of 2 lb. (.9
                                         kg) egg mix per 2\1/2\ doz.
                                         fresh eggs.
Cereal (hot or cold)..................  36 oz. dry (1 kg).
Juice\2\
  Single strength juice...............  184 fluid oz. (5.4 L).
        or
  Frozen concentrated juice...........  192 fluid oz. reconstituted (5.7
                                         L).
------------------------------------------------------------------------
\1\ Additional cheese may be issued on an individual basis in cases of
  lactose intolerance, provided the need is documented in the
  participant's file by the competent professional authority.
\2\ Combinations of single strength or frozen concentrated juice may be
  issued as long as the total volume does not exceed the amount
  specified for single strength juice.

    (7) Food Package VII--Breastfeeding Women (Enhanced). (i) 
Pasteurized fluid whole milk which is flavored or unflavored and which 
contains 400 International Units of Vitamin D per quart (.9 liter) or 
pasteurized fluid skim or lowfat milk which is flavored or unflavored 
and which contains 400 International Units of vitamin D and 2000 
International Units of vitamin A per fluid quart (.9 liter); or 
pasteurized cultured buttermilk which contains 400 International Units 
of vitamin D and 2000 International Units of vitamin A per fluid quart 
(.9 liter); or evaporated whole milk which contains 400 International 
Units of vitamin D per reconstituted quart (.9 liter); or evaporated 
skim milk which contains 400 International Units of vitamin D and 2000 
International Units of vitamin A per reconstituted quart (.9 liter); or 
dry whole milk which contains 400 International Units of vitamin D per 
reconstituted quart (.9 liter); or nonfat or lowfat dry milk which 
contains 400 International Units of vitamin D and 2000 International 
Units of vitamin A per reconstituted quart (.9 liter); or domestic 
cheese (pasteurized process American, Monterey Jack, Colby, natural 
Cheddar, Swiss, Brick, Muenster, Provolone, Mozzarella Part-Skim or 
Whole).
    (ii) Domestic cheese (pasteurized process American, Monterey Jack, 
Colby, natural Cheddar, Swiss, Brick, Muenster, Provolone, Mozzarella 
Part-Skim or Whole).
    (iii) Adult cereal (hot or cold) which contains a minimum of 28 
milligrams of iron per 100 grams of dry cereal and not more than 21.2 
grams of sucrose and other sugars per 100 grams of dry cereal (6 grams 
per ounce).
    (iv) Single strength fruit juice or vegetable juice, or both, which 
contains a minimum of 30 milligrams of vitamin C per 100 milliliters; or 
frozen

[[Page 377]]

concentrated fruit or vegetable juice, or both, which contains a minimum 
of 30 milligrams of vitamin C per 100 milliliters of reconstituted 
juice.
    (v) Eggs or dried egg mix.
    (vi) Peanut butter.
    (vii) Mature dry beans or peas, including but not limited to 
lentils, black, navy, kidney, garbanzo, soy, pinto and mung beans, 
crowder, cow, split and black-eyed peas.
    (viii) Tuna: Canned white, light, dark or blended tuna packed in 
water or oil, including solid and solid pack; chunk, chunks and chunk 
style; flake and flakes; and grated.
    (ix) Carrots: Raw, canned or frozen. Mature raw; canned and frozen 
carrots containing only the mature root of the carrot plant packed in 
water.
    (x) The quantities and types of supplemental foods prescribed shall 
be appropriate for the participant taking into consideration the 
participant's age and dietary needs. The maximum quantity of 
supplemental foods authorized per month is as follows:

------------------------------------------------------------------------
             Food                               Quantity
------------------------------------------------------------------------
Milk:
    Fluid whole milk or......  28 qt. (26.5 L).
    Cheese or................  May be substituted for fluid whole milk
                                at the rate of 1 lb. (.4 kg) per 3 qt.
                                (2.8 L) of fluid whole milk. 4 lbs. (1.8
                                kg) is the maximum amount which may be
                                substituted.
                               Additional cheese may be issued on an
                                individual basis in cases of lactose
                                intolerance, provided the need is
                                documented in the participant's file by
                                the competent professional authority.
    Fluid skim or lowfat milk  May be substituted for fluid whole milk
     or.                        on a quart-for-quart (.9 L) basis.
    Cultured buttermilk or...  May be substituted for fluid whole milk
                                on a quart-for-quart (.9 L) basis.
    Evaporated whole milk or.  May be substituted for fluid whole milk
                                at the rate of 13 fluid oz. (.4 L) per
                                qt. (.9 L) of fluid whole milk.
    Evaporated skimmed milk    May be substituted for fluid whole milk
     or.                        at the rate of 13 fluid oz. (.4 L) per
                                qt. (.9 L) of fluid whole milk.
    Dry whole milk or........  May be substituted for fluid whole milk
                                at the rate of 1 lb. (.4 kg) per 3 qt.
                                (2.8 L) of fluid whole milk.
    Nonfat or lowfat dry milk  May be substituted for fluid whole milk
                                at the rate of 1 lb. (.4 kg) per 5 qt.
                                (4.7 L) of fluid whole milk.
Cheese:
    Cheese...................  1 lb. (.4 kg).
Eggs:
    Eggs or..................  2 doz. or 2\1/2\ doz.
    Dried egg mix............  May be substituted at the rate of 1.5 lb.
                                (.7 kg) egg mix per 2 doz. fresh eggs,
                                or 2 lb. (.9 kg) egg mix per 2\1/2\ doz.
                                fresh eggs.
Cereals:
    Cereals (hot or cold)....  36 oz. dry (1 kg).
Juice:
    Single strength juice or.  322 fluid oz. (9.6 L).
    Frozen concentrated juice  336 fluid oz. reconstituted (10.0 L).
                               Combinations of single strength or frozen
                                concentrated juice may be issued as long
                                as the total volume does not exceed the
                                amount specified for single strength
                                juice.
Legumes:
    Dry beans or peas and....  1 lb. (.4 kg). May be substituted for
                                peanut butter at the rate of 1 lb. of
                                dry beans or peas per 18 oz. of peanut
                                butter.
    Peanut butter............  18 oz. (.5 kg). Peanut butter may not be
                                substituted for mature dry beans or peas
                                at any rate.
Fish:
    Tuna.....................  26 oz. (.8 kg).
Vegetable:
    Raw carrots or...........  2 lb. (.9 kg).
    Frozen carrots or........  May be substituted for fresh at the rate
                                of 1 lb. frozen per 1 lb. fresh.
    Canned carrots...........  May be substituted for fresh at the rate
                                of 1 16-20 ounce can of carrots per 1
                                lb. fresh.
------------------------------------------------------------------------

    (d) Use of commodity foods. (1) At the request of a State agency, 
the Department will purchase commodity foods for the State agency using 
funds allocated to the State agency. The commodity foods purchased and 
made available to the State agency shall be equivalent to the foods 
specified in paragraph (c) of this section.
    (2) The State agency shall--
    (i) Distribute the commodity foods to the local agency or 
participant;

[[Page 378]]

    (ii) Ensure satisfactory storage conditions for the commodity foods, 
including documentation of proper insurance; and
    (iii) Ensure that there are proper storage facilities for commodity 
foods.
    (e) Plans for substitutions or eliminations. (1) The State agency 
may submit to FNS a plan for substitution of food(s) acceptable for use 
in the Program to allow for different cultural eating patterns and 
substitution or elimination of a category of foods to accommodate the 
special needs of homeless persons, and/or residents of institutions if 
the State agency chooses to serve such persons under Sec. 246.7(m)(2) 
of this part. The plan shall provide the State agency's justification, 
including a specific explanation of the cultural eating pattern or the 
homeless situation which requires the proposed alteration and other 
information necessary for FNS to evaluate the plan as specified in 
paragraph (e)(2) of this section for cultural substitutions and in 
paragraph (e)(3) of this section for homeless substitutions or 
eliminations.
    (2) FNS will evaluate a State agency's plan for substitution of 
foods for different cultural eating patterns based on the following 
criteria:
    (i) Any proposed substitute food must be nutritionally equivalent or 
superior to the food it is intended to replace.
    (ii) The proposed substitute must be widely available to 
participants in the areas where the substitute is intended to be used.
    (iii) The cost of the substitute must be equivalent to or less than 
the cost of the food it is intended to replace.
    (3) FNS will evaluate a State agency's plan for substitution or 
elimination of a food category to accommodate the special needs of a 
specific group of homeless persons based on the justification presented 
by the State agency documenting the need. Documentation shall illustrate 
that all alternatives from within existing food packages have been 
explored and shall include a specific description of the circumstances 
of the homeless persons to be served that necessitate the proposed food 
package alteration.
    (4) FNS will make a determination on the proposed plan based on the 
evaluation criteria specified in paragraph (e)(2) or (e)(3) of this 
section, as appropriate. The State agency shall substitute or eliminate 
foods only after receiving the written approval of FNS.
    (f) Infant formula manufacturer registration. Infant formula 
manufacturers supplying formula to the WIC Program shall register with 
the Secretary of Health and Human Services under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321 et seq.). Such manufacturers wishing to 
bid for a State contract to supply infant formula to the program shall 
first certify with the State health department that their formulas 
comply with the Federal Food, Drug, and Cosmetic Act and regulations 
issued pursuant to the Act.

[50 FR 6121, Feb. 13, 1985; 50 FR 8098, Feb. 28, 1985, as amended at 51 
FR 13208, Apr. 18, 1986; 51 FR 16155, May 1, 1986; 53 FR 25314, July 6, 
1988; 54 FR 51295, Dec. 14, 1989; 57 FR 34506, Aug. 5, 1992; 57 FR 
56240, Nov. 27, 1992; 65 FR 51223, Aug. 23, 2000]

    Effective Date Note: At 72 FR 68985, Dec. 6, 2007, Sec. 246.10 was 
revised, effective February 4, 2008. For the convenience of the user, 
the revised text is set forth as follows:

[Page 378-392]
 
                          TITLE 7--AGRICULTURE
 
    CHAPTER II--FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE
 
PART 246_SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND 
 
                     Subpart D_Participant Benefits
 
Sec. 246.10  Supplemental foods.

    (a) General. This section prescribes the requirements for providing 
supplemental foods to participants. The State agency must ensure that 
local agencies comply with this section.
    (b) State agency responsibilities. (1) State agencies may:
    (i) Establish criteria in addition to the minimum Federal 
requirements in Table 4 of paragraph (e)(12) of this section, except 
that the State agency may not establish further restrictions on the 
eligible fruits and vegetables, for the supplemental foods in their 
States. These State criteria could address, but not be limited to, other 
nutritional standards, competitive cost, State-wide availability, and 
participant appeal; and
    (ii) Make food package adjustments to better accommodate 
participants who are homeless. At the State agency's option, these 
adjustments would include, but not be limited to, issuing authorized 
supplemental foods in individual serving-size containers to accommodate 
lack of food storage or preparation facilities.
    (2) State agencies must:
    (i) Identify the brands of foods and package sizes that are 
acceptable for use in the Program in their States in accordance with the 
requirements of this section. State agencies must also provide to local 
agencies, and include in the State Plan, a list of acceptable

[[Page 379]]

foods and their maximum monthly allowances as specified in Tables 1 
through 4 of paragraphs (e)(9) through (e)(12) of this section; and
    (ii) Ensure that local agencies:
    (A) Make available to participants the maximum monthly allowances of 
authorized supplemental foods, except as noted in paragraph (c) of this 
section, and abide by the authorized substitution rates for WIC food 
substitutions as specified in Tables 1 through 3 of paragraphs (e)(9) 
through (e)(11) of this section;
    (B) Make available to participants more than one food from each WIC 
food category except for the categories of peanut butter and eggs, and 
any of the WIC-eligible fruits and vegetables (fresh or processed) in 
each authorized food package as listed in paragraph (e) of this section;
    (C) Authorize only a competent professional authority to prescribe 
the categories of authorized supplemental foods in quantities that do 
not exceed the regulatory maximum and are appropriate for the 
participant, taking into consideration the participant's age and 
nutritional needs; and
    (D) Advise participants or their caretaker, when appropriate, that 
the supplemental foods issued are only for their personal use. However, 
the supplemental foods are not authorized for participant use while 
hospitalized on an in-patient basis. In addition, consistent with Sec. 
246.7(m)(1)(i)(B), supplemental foods are not authorized for use in the 
preparation of meals served in a communal food service. This restriction 
does not preclude the provision or use of supplemental foods for 
individual participants in a nonresidential setting (e.g., child care 
facility, family day care home, school, or other educational program); a 
homeless facility that meets the requirements of Sec. 246.7(m)(1); or, 
at the State agency's discretion, a residential institution (e.g., home 
for pregnant teens, prison, or residential drug treatment center) that 
meets the requirements currently set forth in Sec. 246.7(m)(1) and 
(m)(2).
    (c) Nutrition tailoring. The full maximum monthly allowances of all 
supplemental foods in all food packages must be made available to 
participants if medically or nutritionally warranted. Reductions in 
these amounts cannot be made for cost-savings, administrative 
convenience, caseload management, or to control vendor abuse. Reductions 
in these amounts cannot be made for categories, groups or subgroups of 
WIC participants. The provision of less than the maximum monthly 
allowances of supplemental foods to an individual WIC participant in all 
food packages is appropriate only when:
    (1) Medically or nutritionally warranted (e.g., to eliminate a food 
due to a food allergy);
    (2) A participant refuses or cannot use the maximum monthly 
allowances; or
    (3) The quantities necessary to supplement another programs' 
contribution to fill a medical prescription would be less than the 
maximum monthly allowances.
    (d) Medical documentation--(1) Supplemental foods requiring medical 
documentation. Medical documentation is required for the issuance of the 
following supplemental foods:
    (i) Any non-contract brand infant formula;
    (ii) Any infant formula prescribed to a child or adult who receives 
Food Package III;
    (iii) Any exempt infant formula;
    (iv) Any WIC-eligible medical food;
    (v) Any authorized supplemental food issued to participants who 
receive Food Package III;
    (vi) Any authorized soy-based beverage or tofu issued to children 
who receive Food Package IV;
    (vii) Any additional authorized cheese issued to children who 
receive Food Package IV that exceeds the maximum substitution rate;
    (viii) Any additional authorized tofu and cheese issued to women who 
receive Food Packages V and VII that exceeds the maximum substitution 
rate; and
    (ix) Any contract brand infant formula that does not meet the 
requirements in Table 4 of paragraph (e)(12) of this section.
    (2) Supplemental foods not requiring medical documentation. (i) 
State agencies may authorize local agencies to issue a non-contract 
brand infant formula that meets the requirements in Table 4 of paragraph 
(e)(12) of this section without medical documentation in order to meet 
religious eating patterns; and
    (ii) The State agency has the discretion to require medical 
documentation for any contract brand infant formula and may decide that 
some contract brand infant formula may not be issued under any 
circumstances.
    (3) Medical Determination. For purposes of this program, medical 
documentation means that a health care professional licensed to write 
medical prescriptions under State law has:
    (i) Made a medical determination that the participant has a 
qualifying condition as described in paragraphs (e)(3) through (e)(7) of 
this section that dictates the use of the supplemental foods, as 
described in paragraph (d)(1) of this section; and
    (ii) Provided the written documentation that meets the technical 
requirements described in paragraphs (d)(4)(ii) and (d)(4)(iii) of this 
section.
    (4) Technical Requirements--(i) Location. All medical documentation 
must be kept on file (electronic or hard copy) at the local clinic. The 
medical documentation kept on file must include the initial telephone 
documentation, when received as described in paragraph (d)(4)(iii)(B) of 
this section.

[[Page 380]]

    (ii) Content. All medical documentation must include the following:
    (A) The name of the authorized WIC formula (infant formula, exempt 
infant formula, WIC-eligible medical food) prescribed, including amount 
needed per day;
    (B) The authorized supplemental food(s) appropriate for the 
qualifying condition(s) and their prescribed amounts;
    (C) Length of time the prescribed WIC formula and/or supplemental 
food is required by the participant;
    (D) The qualifying condition(s) for issuance of the authorized 
supplemental food(s) requiring medical documentation, as described in 
paragraphs (e)(3) through (e)(7) of this section; and
    (E) Signature, date and contact information (or name, date and 
contact information), if the initial medical documentation was received 
by telephone and the signed document is forthcoming, of the health care 
professional licensed by the State to write prescriptions in accordance 
with State laws.
    (iii) Written confirmation--(A) General. Medical documentation must 
be written and may be provided as an original written document, an 
electronic document, by facsimile or by telephone to a competent 
professional authority until written confirmation is received.
    (B) Medical documentation provided by telephone. Medical 
documentation may be provided by telephone to a competent professional 
authority who must promptly document the information. The collection of 
the required information by telephone for medical documentation purposes 
may only be used until written confirmation is received from a health 
care professional licensed to write medical prescriptions and used only 
when absolutely necessary on an individual participant basis. The local 
clinic must obtain written confirmation of the medical documentation 
within a reasonable amount of time (i.e., one or two week's time) after 
accepting the initial medical documentation by telephone.
    (5) Medical supervision requirements. Due to the nature of the 
health conditions of participants who are issued supplemental foods that 
require medical documentation, close medical supervision is essential 
for each participant's dietary management. The responsibility remains 
with the participant's health care provider for this medical oversight 
and instruction. This responsibility cannot be assumed by personnel at 
the WIC State or local agency. However, it would be the responsibility 
of the WIC competent professional authority to ensure that only the 
amounts of supplemental foods prescribed by the participant's health 
care provider are issued in the participant's food package.
    (e) Food packages. There are seven food packages available under the 
Program that may be provided to participants. The authorized 
supplemental foods must be prescribed from food packages according to 
the category and nutritional needs of the participant. The food packages 
are as follows:
    (1) Food Package I--Infants birth through 5 months--(i) Participant 
category served. This food package is designed for issuance to infant 
participants from birth through age 5 months who do not have a condition 
qualifying them to receive Food Package III.
    (ii) Infant feeding categories--(A) Birth to one month. Three infant 
feeding options are available during the first month after birth--fully 
breastfeeding, i.e., the infant receives no infant formula from the WIC 
Program; partially breastfeeding, i.e., the infant receives not more 
than 104 reconstituted fluid ounces of formula; or fully formula-
feeding. Infant formula is not provided during the first month after 
birth to fully breastfed infants to support the successful establishment 
of breastfeeding.
    (B) One through 5 months. Three infant feeding options are available 
from 1 months through 5 months--fully breastfeeding, fully formula-
feeding, or partially breastfeeding, i.e., the infant is breastfed but 
also receives infant formula from the WIC Program in an amount not to 
exceed approximately half the amount of infant formula allowed for a 
fully formula fed infant.
    (iii) Infant formula requirements. This food package provides iron-
fortified infant formula that is not an exempt infant formula. The 
issuance of any contract brand or noncontract brand infant formula that 
contains less than 10 milligrams of iron per liter at standard dilution 
(i.e., approximately 20 kilocalories per fluid ounce of prepared 
formula) is prohibited. Except as specified in paragraph (d) of this 
section, local agencies must issue a contract brand infant formula that 
meets the requirements in Table 4 of paragraph (e)(12) of this section.
    (iv) Physical forms. Local agencies must issue all WIC formulas (WIC 
formulas mean all infant formula, exempt infant formula and WIC-eligible 
medical foods) in concentrated liquid or powder physical forms. Ready-
to-feed WIC formulas may be authorized when the competent professional 
authority determines and documents that:
    (A) The participant's household has an unsanitary or restricted 
water supply or poor refrigeration;
    (B) The person caring for the participant may have difficulty in 
correctly diluting concentrated or powder forms; or
    (C) The WIC infant formula is only available in ready-to-feed.
    (v) Authorized category of supplemental foods. Infant formula is the 
only category of supplemental foods authorized in this food package. 
Exempt infant formulas and WIC-eligible medical foods are authorized 
only in Food Package III.

[[Page 381]]

    (2) Food Package II--Infants 6 through 11 months--(i) Participant 
category served. This food package is designed for issuance to infant 
participants from 6 through 11 months of age who do not have a condition 
qualifying them to receive Food Package III.
    (ii) Infant feeding options. Three infant feeding options are 
available--fully breastfeeding, fully formula-feeding, or partially 
breastfeeding.
    (iii) Infant formula requirements. The requirements for issuance of 
infant formula in Food Package I, specified in paragraphs (e)(1)(iii) 
and (e)(1)(iv) of this section, also apply to the issuance of infant 
formula in Food Package II.
    (iv) Authorized categories of supplemental foods. Infant formula, 
infant fruits and vegetables, infant meat, and infant cereal are the 
categories of supplemental foods authorized in this food package.
    (3) Food Package III--Participants with qualifying conditions--(i) 
Participant category served and qualifying conditions. This food package 
is reserved for issuance to women, infants and child participants who 
have a documented qualifying condition that requires the use of a WIC 
formula (infant formula, exempt infant formula or WIC-eligible medical 
food) because the use of conventional foods is precluded, restricted, or 
inadequate to address their special nutritional needs. Medical 
documentation must meet the requirements described in paragraph (d) of 
this section. Participants who are eligible to receive this food package 
must have one or more qualifying conditions, as determined by a health 
care professional licensed to write medical prescriptions under State 
law. The qualifying conditions include but are not limited to premature 
birth, low birth weight, failure to thrive, inborn errors of metabolism 
and metabolic disorders, gastrointestinal disorders, malabsorption 
syndromes, immune system disorders, severe food allergies that require 
an elemental formula, and life threatening disorders, diseases and 
medical conditions that impair ingestion, digestion, absorption or the 
utilization of nutrients that could adversely affect the participant's 
nutrition status. This food package may not be issued solely for the 
purpose of enhancing nutrient intake or managing body weight.
    (ii) Non-authorized issuance of Food Package III. This food package 
is not authorized for:
    (A) Infants whose only condition is:
    (1) A diagnosed formula intolerance or food allergy to lactose, 
sucrose, milk protein or soy protein that does not require the use of an 
exempt infant formula; or
    (2) A non-specific formula or food intolerance.
    (B) Women and children who have a food intolerance to lactose or 
milk protein that can be successfully managed with the use of one of the 
other WIC food packages (i.e., Food Packages IV-VII); or
    (C) Any participant solely for the purpose of enhancing nutrient 
intake or managing body weight without an underlying qualifying 
condition.
    (iii) Restrictions on the issuance of WIC formulas in ready-to-feed 
(RTF) forms. WIC State agencies must issue WIC formulas (infant formula, 
exempt infant formula and WIC-eligible medical foods) in concentrated 
liquid or powder physical forms unless the requirements for issuing RTF 
are met as described in paragraph (e)(1)(iv) of this section. In 
addition to those requirements, there are two additional conditions 
which may be used to issue RTF in Food Package III:
    (A) If a ready-to-feed form better accommodates the participant's 
condition; or
    (B) If it improves the participant's compliance in consuming the 
prescribed WIC formula.
    (iv) Unauthorized WIC costs. All apparatus or devices (e.g., enteral 
feeding tubes, bags and pumps) designed to administer WIC formulas are 
not allowable WIC costs.
    (v) Authorized categories of supplemental foods. The supplemental 
foods authorized in this food package require medical documentation for 
issuance and include infant formula (for children or women), exempt 
infant formula, WIC-eligible medical foods, infant cereal, infant food 
fruits and vegetables, milk and milk alternatives, cheese, eggs, canned 
fish, fruits and vegetables, breakfast cereal, whole wheat bread or 
other whole grains, juice, legumes and/or peanut butter.
    (vi) Coordination with medical payors and other programs that 
provide or reimburse for formulas. WIC State agencies must coordinate 
with other Federal, State or local government agencies or with private 
agencies that operate programs that also provide or could reimburse for 
exempt infant formulas and WIC-eligible medical foods benefits to mutual 
participants. At a minimum, a WIC State agency must coordinate with the 
State Medicaid Program for the provision of exempt infant formulas and 
WIC-eligible medical foods that are authorized or could be authorized 
under the State Medicaid Program for reimbursement and that are 
prescribed for WIC participants who are also Medicaid recipients. The 
WIC State agency is responsible for providing up to the maximum amount 
of exempt infant formulas and WIC-eligible medical foods under Food 
Package III in situations where reimbursement is not provided by another 
entity.
    (4) Food Package IV--Children 1 through 4 years--(i) Participant 
category served. This food package is designed for issuance to 
participants 1 through 4 years of age who do not have a condition 
qualifying them to receive Food Package III.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fruits

[[Page 382]]

and vegetables, whole wheat bread or other whole grains, eggs, and 
legumes or peanut butter are the categories of supplemental foods 
authorized in this food package. Cheese may be substituted for milk in 
amounts described in Table 2 of paragraph (e)(10) of this section. 
Substitutions exceeding the maximum substitution allowance of cheese, up 
to the maximum allowance for fluid milk, may be allowed with medical 
documentation of the qualifying condition. Soy-based beverage and tofu 
can be substituted for milk only with medical documentation in this food 
package, in amounts described in Table 2 of paragraph (e)(10) of this 
section. A health care professional licensed by the State to write 
prescriptions must make a medical determination and provide medical 
documentation that a child cannot drink milk and requires soy-based 
beverage, tofu, or additional cheese as a substitute for milk. Such 
determination can be made for situations that include, but are not 
limited to, milk allergy, severe lactose maldigestion, and vegan diets. 
Medical documentation must meet the requirements described in paragraph 
(d) of this section.
    (5) Food Package V--Pregnant and partially breastfeeding women--(i) 
Participant category served. This food package is designed for issuance 
to women participants with singleton pregnancies who do not have a 
condition qualifying them to receive Food Package III. This food package 
is also designed for issuance to breastfeeding women participants, up to 
1 year postpartum, who do not have a condition qualifying them to 
receive Food Package III and whose partially breastfed infants receive 
formula from the WIC program in amounts that do not exceed the maximum 
allowances described in Table 1 of paragraph (e)(9) of this section. 
Women participants breastfeeding more than one infant, and women 
participants pregnant with more than one fetus, are eligible to receive 
Food Package VII as described in paragraph (e)(7) of this section.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fruits and vegetables, whole wheat bread or other whole 
grains, eggs, legumes and peanut butter are the categories of 
supplemental foods authorized in this food package. Cheese or calcium-
set tofu may be substituted for milk in amounts described in Table 2 of 
paragraph (e)(10) of this section. Amounts of cheese or calcium-set tofu 
exceeding the maximum substitution allowances may be allowed with 
medical documentation of the qualifying condition, up to the maximum 
allowance for fluid milk. A health care professional licensed by the 
State to write prescriptions must make a medical determination and 
provide medical documentation that a woman cannot drink milk and 
requires additional cheese or calcium-set tofu. Such determination can 
be made for situations that include, but are not limited to, milk 
allergy or severe lactose maldigestion. Medical documentation must meet 
the requirements described in paragraph (d) of this section.
    (6) Food Package VI--Postpartum women--(i) Participant category 
served. This food package is designed for issuance to women up to 6 
months postpartum who are not breastfeeding their infants, and to 
breastfeeding women up to 6 months postpartum whose participating infant 
receives more than the maximum amount of formula allowed for partially 
breastfed infants as described in Table 1 of paragraph (e)(9) of this 
section.
    (ii) Authorized categories of supplemental foods. Milk, breakfast 
cereal, juice, fruits and vegetables, eggs, and legumes or peanut butter 
are the categories of supplemental foods authorized in this food 
package. Cheese or calcium-set tofu may be substituted for milk in 
amounts described in Table 2 of paragraph (e)(10) of this section. 
Amounts of cheese or calcium-set tofu exceeding the maximum substitution 
allowances may be allowed with medical documentation of the qualifying 
condition, up to the maximum allowance for fluid milk. A health care 
professional licensed by the State to write prescriptions must make a 
medical determination and provide medical documentation that a woman 
cannot drink milk and requires additional cheese or calcium-set tofu. 
Such determination can be made for situations that include, but are not 
limited to, milk allergy or severe lactose maldigestion. Medical 
documentation must meet the requirements described in paragraph (d) of 
this section.
    (7) Food Package VII--Fully breastfeeding--(i) Participant category 
served. This food package is designed for issuance to breastfeeding 
women up to 1 year postpartum whose infants do not receive infant 
formula from WIC (these breastfeeding women are assumed to be fully 
breastfeeding their infants). This food package is also designed for 
issuance to women participants pregnant with two or more fetuses, and 
women participants partially breastfeeding multiple infants. Women 
participants fully breastfeeding multiple infants receive 1.5 times the 
supplemental foods provided in Food Package VII.
    (ii) Authorized categories of supplemental foods. Milk, cheese, 
breakfast cereal, juice, fruits and vegetables, whole wheat bread or 
other whole grains, eggs, legumes, peanut butter, and canned fish are 
the categories of supplemental foods authorized in this food package. 
Cheese or calcium-set tofu may be substituted for milk in amounts 
described in Table 2 of paragraph (e)(10) of this section. Amounts of 
cheese or calcium-set tofu exceeding the maximum substitution allowances 
may be allowed with medical documentation of the qualifying condition, 
up to the maximum allowance for fluid milk. A

[[Page 383]]

health care professional licensed by the State to write prescriptions 
must make a medical determination and provide medical documentation that 
a woman cannot drink milk and requires additional cheese or calcium-set 
tofu. Such determination can be made for situations that include, but 
are not limited to, milk allergy or severe lactose maldigestion. Medical 
documentation must meet the requirements described in paragraph (d) of 
this section.
    (8) Supplemental Foods--Maximum monthly allowances, options and 
substitution rates, and minimum requirements. Tables 1 through 3 of 
paragraphs (e)(9) through (e)(11) of this section specify the maximum 
monthly allowances of foods in WIC food packages and identify WIC food 
options and substitution rates. Table 4 of paragraph (e)(12) of this 
section describes the minimum requirements and specifications of 
supplemental foods in the WIC food packages.
    (9) Maximum monthly allowances of supplemental foods for infants. 
The maximum monthly allowances, options and substitution rates of 
supplemental foods for infants in Food Packages I, II and III are stated 
in Table 1 as follows:

[[Page 384]]



                          Table 1.--Maximum Monthly Allowances of Supplemental Foods for Infants in Food Packages I, II and III
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Fully formula fed (FF)              Partially breastfed (BF/FF)                  Fully breastfed (BF)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Food packages I-
                                Food packages  I-                     BF/FF & III BF/FF
                                FF & III-FF  A: 0  Food packages  II-   A: 0 to 1 month  Food packages  II-
           Foods \1\             through 3 months    FF & III-FF  6   \2\  B: 1 through   BF/FF &  III BF/  Food package  I-BF  0  Food package II-BF  6
                                  B: 4 through 5   through 11 months   3 months \2\  C:  FF   6 through 11     through 5 months      through 11 months
                                      months                             4 through 5           months
                                                                            months
--------------------------------------------------------------------------------------------------------------------------------------------------------
WIC Formula 4 5 6 7...........  A: 806 fl oz       624 fl oz          A: 104 fl oz       312 fl oz
                                 reconstituted      reconstituted      reconstituted      reconstituted
                                 liquid             liquid             powder \3\         liquid
                                 concentrate or     concentrate or    B: 364 fl oz        concentrate or
                                 832 fl oz RTF or   640 fl oz RTF or   reconstituted      320 fl oz RTF or
                                 870 fl oz         696 fl oz           liquid            384 fl oz
                                 reconstituted      reconstituted      concentrate or     reconstituted
                                 powder.            powder.            384 fl oz RTF or   powder.
                                B: 884 fl oz                           435 fl oz
                                 reconstituted                         reconstituted
                                 liquid                                powder.
                                 concentrate or                       C: 442 fl oz
                                 896 fl oz RTF or                      reconstituted
                                 960 fl oz                             liquid
                                 reconstituted                         concentrate or
                                 powder.                               448 fl oz RTF or
                                                                       522 fl oz
                                                                       reconstituted
                                                                       powder.
Infant cereal \8\.............  .................  24 oz............  .................  24 oz............  .....................  24 oz.
Infant food fruits and          128 oz...........  128 oz...........  256 oz...........
 vegetables 8 9 10.
Infant food--meat 8 10........  .................  .................  .................  .................  .....................  77.5 oz.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 1 Footnotes: (abbreviations in order of appearance in table): FF = fully formula fed; BF/FF = partially breastfed (i.e., the infant is breastfed
  but also receives formula from the WIC Program); BF = fully breastfed (i.e., the infant receives no formula through the WIC program).
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods.
\2\ The powder form is the form recommended for partially breastfed infants ages 0 through 3 months in Food Package I.
\3\ Liquid concentrate and ready-to-feed (RTF) may be substituted at rates that provide comparable nutritive value.
\4\ WIC formula means infant formula, exempt infant formula, or WIC-eligible medical food. Only infant formula may be issued for infants in Food
  Packages I and II. Exempt infant formula may only be issued for infants in Food Package III.
\5\ The maximum monthly allowance is specified in reconstituted fluid ounces for liquid concentrate, RTF liquid, and powder forms of infant formula and
  exempt infant formula. Reconstituted fluid ounce is the form prepared for consumption as directed on the container.
\6\ If powder infant formula is provided, State agencies must provide at least the number of reconstituted fluid ounces as the maximum allowance for the
  liquid concentrate form of the same product in the same Food Package up to the maximum monthly allowance for powder. State agencies must issue whole
  containers that are all the same size.
\7\ State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the
  full authorized nutritional benefit (FNB). State agencies must use the methodology described in accordance with paragraph (h)(1) of this section.
\8\ State agencies may round up and disperse whole containers of infant foods (infant cereal, fruits and vegetables, and meat) over the Food Package
  timeframe. State agencies must use the methodology described in accordance with paragraph (h)(2) of this section.
\9\ Fresh banana may replace up to 16 ounces of infant food fruit at a rate of 1 pound of bananas per 8 ounces of infant food fruit.
\10\ In lieu of infant foods (cereal, fruit and vegetables, and meat), infants greater than 6 months of age in Food Package III may receive exempt
  infant formula or WIC-eligible medical foods at the same maximum monthly allowance as infants ages 4 through 5 months of age of the same feeding
  option.


[[Page 385]]

    (10) Maximum monthly allowances of supplemental foods in Food 
Packages IV through VII. The maximum monthly allowances, options and 
substitution rates of supplemental foods for children and women in Food 
Package IV through VII are stated in Table 2 as follows:

Table 2.--Maximum Monthly Allowances of Supplemental Foods for Children and Women in Food Packages IV, V, VI and
                                                       VII
----------------------------------------------------------------------------------------------------------------
                                       Children                                  Women
                                 -------------------------------------------------------------------------------
                                                        Food package V:
                                                         Pregnant and      Food package VI:    Food package VII:
            Foods \1\             Food package IV  1       partially       Postpartum (up to         Fully
                                    through 4 years    breastfeeding (up       6 months        breastfeeding (up
                                                           to 1 year        postpartum) \3\     to 1 year post-
                                                        postpartum) \2\                         partum) \4\ \5\
----------------------------------------------------------------------------------------------------------------
Juice, single strength \6\......  128 fl oz.........  144 fl oz.........  96 fl oz..........  144 fl oz.
Milk, fluid.....................  16 qt 7 8 9 10....  22 qt. 7 8 11 12..  16 qt. 7 8 11 12..  24 qt. 7 8 11 12
Breakfast cereal \13\...........  36 oz.............  36 oz.............  36 oz.............  36 oz.
Cheese..........................  N/A...............  N/A...............  N/A...............  1 lb.
Eggs............................  1 dozen...........  1 dozen...........  1 dozen...........  2 dozen.
Fruits and vegetables 14 15.....  $6.00 in cash       $8.00 in cash-      $8.00 in cash-      $10.00 in cash-
                                   value vouchers.     value vouchers.     value vouchers.     value vouchers.
Whole wheat bread or other whole  2 lb..............  1 lb..............  N/A...............  1 lb.
 grains \16\.
Fish (canned)...................  N/A...............  N/A...............  N/A...............  30 oz.
Legumes, dry \17\...............  1 lb..............  1 lb..............  1 lb..............  1 lb.
And/or peanut butter............  Or 18 oz..........  And 18 oz.........  Or 18 oz..........  And 18 oz.
----------------------------------------------------------------------------------------------------------------
Table 2 Footnotes: N/A = the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the
  supplemental foods.
\2\ Food Package V is issued to two categories of WIC participants: Women participants with singleton
  pregnancies and breastfeeding women whose partially breastfed infants receive formula from the WIC Program in
  amounts that do not exceed the maximum formula allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C,
  or II-BF/FF, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this
  section.
\3\ Food Package VI is issued to two categories of WIC participants: Non-breastfeeding postpartum women and
  breastfeeding postpartum women whose partially breastfed infants receive more than the maximum infant formula
  allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C or II-BF/FF, as appropriate for the age of the
  infant as described in Table 1 of paragraph (e)(9) of this section.
\4\ Food Package VII is issued to three categories of WIC participants: Fully breastfeeding women whose infants
  do not receive formula from the WIC Program; women pregnant with two or more fetuses; and women fully or
  partially breastfeeding multiple infants.
\5\ Women fully breastfeeding multiple infants are prescribed 1.5 times the maximum allowances.
\6\ Combinations of single-strength and concentrated juices may be issued provided that the total volume does
  not exceed the maximum monthly allowance for single-strength juice.
\7\ Whole milk, as specified in FDA standards, is the only type of milk allowed for 1-year-old children (12
  through 23 months). Reduced fat milks, as specified in FDA standards, i.e., 2% milk fat, are the only types of
  milk allowed for children = 24 months of age and women.
\8\ Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of
  fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate
  to fluid milk. When a combination of different milk forms is provided, the full maximum monthly fluid milk
  allowance must be provided.
\9\ For children, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. No
  more than 1 lb. of cheese may be substituted for milk. With medical documentation, additional amounts of
  cheese may be substituted in cases of lactose intolerance or other qualifying conditions, up to the maximum
  allowance for fluid milk.
\10\ For children, soy-based beverage and calcium-set tofu may be substituted for milk only with medical
  documentation for qualifying conditions. Soy-based beverage may be substituted for milk, with medical
  documentation, for children in Food Package IV on a quart for quart basis up to the total maximum allowance of
  milk. Tofu may be substituted for milk, with medical documentation, for children in Food Package IV at the
  rate of 1 pound of tofu per 1 quart of milk up to the total maximum allowance of milk.
\11\ For women, cheese or calcium-set tofu may be substituted for milk at the rate of 1 pound of cheese per 3
  quarts of milk or 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in
  this manner in Food Packages V and VI; however, no more than 1 pound of cheese may be substituted for milk. A
  maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore, no more than 2
  lbs. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese or tofu
  may be substituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other
  qualifying conditions.
\12\ For women, soy-based beverage may be substituted for milk at the rate of 1 quart of soy-based beverage for
  1 quart of milk up to the total maximum monthly allowance of milk.
\13\ At least one-half of the total number of breakfast cereals on the State agency's authorized food list must
  have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a
  ``whole grain food with moderate fat content'' as defined in Table 4 of paragraph (e)(12) of this section.
\14\ Processed (canned, frozen, dried) fruits and vegetables may be substituted for fresh fruits and vegetables.
  Dried fruit and dried vegetables are not authorized for children in Food Package IV.
\15\ The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as
  described in Sec.  246.16(j).
\16\ Brown rice, bulgur (cracked wheat), oatmeal, whole-grain barley, soft corn or whole wheat tortillas may be
  substituted for whole wheat bread on an equal weight basis.
\17\ Canned legumes may be substituted for dried legumes at the rate of 64 oz. of canned beans for 1 lb. dried
  beans. Under Food Packages V and VII, two additional combinations of dry or canned beans/peas are authorized:
  1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry or 128 oz. Canned beans/peas (and
  no peanut butter) or 36 oz. peanut butter (and no beans).


[[Page 386]]

    (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:

[[Page 387]]



      Table 3.--Maximum Monthly Allowances of Supplemental Foods for Children and Women in Food Package III
----------------------------------------------------------------------------------------------------------------
                                       Children                                  Women
                                 -------------------------------------------------------------------------------
                                                         Pregnant and
            Foods\1\                                       partially       Postpartum (up to         Fully
                                   1 through 4 years   breastfeeding (up       6 months       breastfeeding, (up
                                                           to 1 year        postpartum) \3\     to 1 year post-
                                                        postpartum) \2\                         partum) \4\ \5\
----------------------------------------------------------------------------------------------------------------
Juice, single strength \6\......  128 fl oz.........  144 fl oz.........  96 fl oz..........  144 fl oz.
WIC Formula \7\ \8\.............  455 fl oz liquid    455 fl oz liquid    455 fl oz liquid    455 fl oz. liquid
                                   concentrate.        concentrate.        concentrate.        concentrate.
Milk............................  16 qt \9\ \10\      22 qt \9\ \10\      16 qt \9\ \10\      24 qt. \9\ \10\
                                   \11\ \12\.          \13\ \14\.          \13\ \14\.          \13\ \14\
Breakfast cereal \15\ \16\......  36 oz.............  36 oz.............  36 oz.............  36 oz.
Cheese..........................  N/A...............  N/A...............  N/A...............  1 lb.
Eggs............................  1 dozen...........  1 dozen...........  1 dozen...........  2 dozen.
Fruits and vegetables \17 18\...  $6.00 in cash       $8.00 in cash       $8.00 in cash       $10.00 in cash
                                   value vouchers.     value vouchers.     value vouchers.     value vouchers.
Whole wheat bread \19\..........  2 lb..............  1 lb..............  N/A...............  1 lb.
Fish (canned)...................  N/A...............  N/A...............  N/A...............  30 oz.
Legumes, dry \20\...............  1 lb..............  1 lb..............  1 lb..............  1 lb.
and/or Peanut butter............  Or 18 oz..........  And 18 oz.........  Or 18 oz..........  And 18 oz.
----------------------------------------------------------------------------------------------------------------
Table 3 Footnotes: N/A=the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the
  supplemental foods.
\2\ Food Package V is issued to two categories of WIC participants--women participants with singleton
  pregnancies and breastfeeding women whose partially breastfed infants receive formula from the WIC Program in
  amounts that do not exceed the maximum formula allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C,
  or II-BF/FF, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this
  section.
\3\ Food Package VI is issued to two categories of WIC participants--non-breastfeeding postpartum women and
  breastfeeding postpartum women whose partially breastfed infants receive more than the maximum formula
  allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C or II-BF/FF, as appropriate for the age of the
  infant as described in Table 1 of paragraph (e)(9) of this section.
\4\ Food Package VII is issued to three categories of WIC participants--fully breastfeeding women whose infants
  do not receive formula from the WIC Program; women pregnant with two or more fetuses; and women fully or
  partially breastfeeding multiple infants.
\5\ Women fully breastfeeding multiple infants are prescribed 1.5 times the maximum allowances.
\6\ Combinations of single-strength and concentrated juices may be issued provided that the total volume does
  not exceed the maximum monthly allowance for single-strength juice.
\7\ WIC formula means infant formula, exempt infant formula, or WIC-eligible medical food.
\8\ Powder and Ready-to-Feed may be substituted at rates that provide comparable nutritive value.
\9\ Whole milk, as specified in FDA standards, is the only type of milk allowed for 1-year-old children (12
  through 23 months). Reduced fat milks, as specified in FDA standards, i.e., 2% milk fat, are the only types of
  milk allowed for children  24 months of age and women. With medical documentation, whole milk may
  be substituted for reduced fat milk for children  24 months of age and women.
\10\ Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of
  fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate
  to fluid milk. When a combination of different milk forms is provided, the full maximum monthly fluid milk
  allowance must be provided.
\11\ For children, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. No
  more than 1 lb. of cheese may be substituted for milk. With medical documentation, additional amounts of
  cheese may be substituted in cases of lactose intolerance or other qualifying conditions, up to the maximum
  allowance for fluid milk.
\12\ For children, soy-based beverage and tofu may be substituted for milk only with medical documentation for
  qualifying conditions. Soy-based beverage may be substituted for milk, with medical documentation, for
  children in Food Package IV on a quart for quart basis up to the total maximum allowance of milk. Tofu may be
  substituted for milk, with medical documentation, for children in Food Package IV at the rate of 1 pound of
  tofu per 1 quart of milk up to the total maximum allowance of milk.
\13\ For women, cheese or calcium-set tofu may be substituted for milk at the rate of l pound of cheese per 3
  quarts of milk or 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in
  this manner in Food Packages V and VI; however, no more than 1 pound of cheese may be substituted for milk. A
  maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore, no more than 2
  lbs. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese or tofu
  may be substituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other
  qualifying conditions.
\14\ For women, soy-based beverage may be substituted for milk at the rate of 1 quart of soy-based beverage for
  1 quart of milk up to the total maximum monthly allowance of milk.
\15\ 32 dry ounces of infant cereal may be substituted for 36 ounces of breakfast cereal.
\16\ At least one half of the total number of breakfast cereals on the State agency's authorized food list must
  have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a
  ``whole grain food with moderate fat content'' as defined in Table 4 of paragraph (e)(12) of this section.
\17\ Processed (canned, frozen, dried) fruits and vegetables may be substituted for fresh fruits and vegetables.
  Dried fruit and dried vegetables are not authorized for children.
\18\ The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as
  described in Sec.  246.16(j).
\19\ Brown rice, bulgur (cracked wheat), oatmeal, whole-grain barley, soft corn or whole wheat tortillas may be
  substituted for whole wheat bread on an equal weight basis.

[[Page 388]]


\20\ Canned legumes may be substituted for dried legumes at the rate of 64 oz of canned beans for 1 lb dried
  beans. Issuance of two additional combinations of dry or canned beans/peas is authorized for the Pregnant and
  Partially Breastfeeding (up to 1 year postpartum) category and Fully Breastfeeding (Enhanced) (up to 1 year
  postpartum) category: 1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry or 128 oz.
  Canned beans/peas (and no peanut butter) or 36 oz. Peanut butter (and no beans).


[[Page 389]]

    (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 1.8 mg iron/100 kilocalories)
                                at standard dilution;
                               (4) Provide at least 67 kilocalories per
                                100 milliliters (approximately 20
                                kilocalories per fluid ounce) at
                                standard dilution.
                               (5) Not require the addition of any
                                ingredients other than water prior to
                                being served in a liquid state.
    Exempt infant formula....  All authorized exempt infant formula must
                                (1) meet the definition and requirements
                                for an exempt infant formula under
                                section 412(h) of the Federal Food,
                                Drug, and Cosmetic Act as amended (21
                                U.S.C. 350a(h)) and the regulations at
                                21 CFR Parts 106 and 107; and
                               2) Be designed for enteral digestion via
                                an oral or tube feeding.
    WIC-eligible medical       Certain enteral products that are
     foods.\1\                  specifically formulated to provide
                                nutritional support for individuals with
                                a qualifying condition, when the use of
                                conventional foods is precluded,
                                restricted, or inadequate. Such WIC-
                                eligible medical foods must serve the
                                purpose of a food, meal or diet (may be
                                nutritionally complete or incomplete)
                                and provide a source of calories and one
                                or more nutrients; be designed for
                                enteral digestion via an oral or tube
                                feeding; and may not be a conventional
                                food, drug, flavoring, or enzyme.
                               WIC-eligible medical foods include many,
                                but not all, products that meet the
                                definition of medical food in Section
                                5(b)(3) of the Orphan Drug Act (21
                                U.S.C. 360ee(b)(3)).
Milk and milk alternatives:
    Cow's milk...............  Must conform to FDA standard of identity
                                for whole, reduced fat, low-fat, or non-
                                fat milks (21 CFR 131.110). Must be
                                pasteurized and contain at least 400 IU
                                of vitamin D per quart (100 IU per cup)
                                and 2000 IU of vitamin A per quart (500
                                IU per cup).
                               May be flavored or unflavored. May be
                                fluid, shelf-stable, evaporated (21 CFR
                                131.130), or dried (i.e., powder) (21
                                CFR 131.147).\2\
                               Cultured Milks. Must conform to FDA
                                standard of identity for cultured milk
                                (21 CFR 131.112--cultured buttermilk,
                                kefir cultured milk, acidophilus
                                cultured milk).
    Goat milk................  Must conform to FDA standard of identity
                                for whole, reduced fat, low-fat, or non-
                                fat milks (21 CFR part 131). Must be
                                pasteurized and contain at least 400 IU
                                of vitamin D per quart (100 IU per cup)
                                and 2000 IU of vitamin A per quart (500
                                IU per cup) following FDA fortification
                                standards (21 CFR part 131). May be
                                flavored or unflavored. May be fluid,
                                shelf-stable, evaporated (21 CFR
                                131.130), or dried (i.e., powdered) (21
                                CFR 131.147).\2\
    Cheese...................  Domestic cheese made from 100 percent
                                pasteurized milk. Must conform to FDA
                                standard of identity (21 CFR Part 133);
                                Monterey Jack, Colby, natural Cheddar,
                                Swiss, Brick, Muenster, Provolone, part-
                                skim or whole Mozzarella, pasteurized
                                processed American, or blends of any of
                                these cheeses are authorized.
                               Cheeses that are labeled low, free,
                                reduced, less or light in the nutrients
                                of sodium, fat or cholesterol are WIC-
                                eligible.\3\
    Tofu.....................  Calcium-set tofu prepared with only
                                calcium salts (e.g., calcium sulfate).
                                May not contain added fats, sugars,
                                oils, or sodium.
    Soy-based beverage.......  Must be fortified to meet the following
                                nutrient levels: 276 mg calcium per cup,
                                8 g protein per cup, 500 IU vitamin A
                                per cup, 100 IU vitamin D per cup, 24 mg
                                magnesium per cup, 222 mg phosphorus per
                                cup, 349 mg potassium per cup, 0.44 mg
                                riboflavin per cup, and 1.1 mcg vitamin
                                B12 per cup, in accordance with
                                fortification guidelines issued by FDA.
Juice........................  Must be pasteurized 100% unsweetened
                                fruit juice. Must conform to FDA
                                standard of identity (21 CFR part 146)
                                or vegetable juice must conform to FDA
                                standard of identity (21 CFR part 156)
                                and contain at least 30 mg of vitamin C
                                per 100 mL of juice. With the exception
                                of 100 percent citrus juices, State
                                agencies must verify the vitamin C
                                content of all State-approved juices.
                                Juices that are fortified with other
                                nutrients may be allowed at the State
                                agency's option. Juice may be fresh,
                                from concentrate, frozen, canned, or
                                shelf-stable.
                               Vegetable juice may be regular or lower
                                in sodium.\3\
Eggs.........................  Fresh shell domestic hens' eggs or dried
                                eggs mix (must conform to FDA standard
                                of identity in 21 CFR 160.105) or
                                pasteurized liquid whole eggs (must
                                conform to FDA standard of identity in
                                21 CFR 160.115).
                               Hard boiled eggs, where readily available
                                for purchase in small quantities, may be
                                provided for homeless participants.

[[Page 390]]


Breakfast cereal.............  Breakfast cereals as defined by FDA in 21
                                CFR 170.3(n)(4) for ready-to-eat and
                                instant and regular hot cereals.
                               Must contain a minimum of 28 mg iron per
                                100 g dry cereal.
                               Must contain <= 21.2 g sucrose and other
                                sugars per 100 g dry cereal (<= 6 g per
                                dry oz).
                               At least half of the cereals authorized
                                on a State agency's food list must have
                                whole grain as the primary ingredient by
                                weight AND meet labeling requirements
                                for making a health claim as a ``whole
                                grain food with moderate fat content'':
                                \4\
                               (1) Contain a minimum of 51% whole grains
                                (using dietary fiber as the indicator);
                               (2) Meet the regulatory definitions for
                                ``low saturated fat'' at 21 CFR 101.62
                                (<= 1 g saturated fat per RACC) and
                                ``low cholesterol'' (<= 20 mg
                                cholesterol per RACC);
                               (3) Bear quantitative trans fat labeling;
                                and
                               (4) Contain <= 6.5 g total fat per RACC
                                and <= 0.5 g trans fat per RACC.
Fruits and Vegetables (fresh   Any variety of fresh whole or cut fruit
 and processed).                without added sugars.\5\
                               Any variety of fresh whole or cut
                                vegetable, except white potatoes,
                                without added sugars, fats, or oils
                                (orange yams and sweet potatoes are
                                allowed).\5\
                               Any variety of canned \6\ fruits (must
                                conform to FDA standard of identity (21
                                CFR part 145); including applesauce,
                                juice pack or water pack without added
                                sugars, fats, oils, or salt (i.e.
                                sodium). Any variety of frozen fruits
                                without added sugars.\7\
                               Any variety of canned \6\ or frozen
                                vegetables (must conform to FDA standard
                                of identity (21 CFR part 155)) except
                                white potatoes (orange yams and sweet
                                potatoes are allowed); without added
                                sugars, fats, or oils. May be regular or
                                lower in sodium.\3 7\
                               Any type of dried fruits or dried
                                vegetable without added sugars, fats,
                                oils, or salt (i.e., sodium).\5\
Whole wheat bread/Whole grain                    Bread
 bread/Other whole             Whole wheat bread must conform to FDA
 unprocessed grains.            standard of identity (21 CFR 136.180).
                                (Includes whole wheat buns and rolls.)
                               AND
                               Whole wheat must be the primary
                                ingredient by weight in all whole wheat
                                bread products.
                               Whole grain bread must meet labeling
                                requirements for making a health claim
                                as a ``whole grain food with moderate
                                fat content'':\4\
                               (1) Contain a minimum of 51% whole grains
                                (using dietary fiber as the indicator);
                               (2) Meet the regulatory definitions for
                                ``low saturated fat'' at 21 CFR 101.62
                                (<= 1 g saturated fat per RACC) and
                                ``low cholesterol'' (<= 20 mg
                                cholesterol per RACC);
                               (3) Bear quantitative trans fat labeling;
                                and
                               (4) Contain <= 6.5 g total fat per RACC
                                and <= 0.5 g trans fat per RACC.
                               AND
                               Whole grain must be the primary
                                ingredient by weight in all whole grain
                                bread products.
                                     Other Whole Unprocessed Grains
                               Brown rice, bulgur (cracked wheat),
                                oatmeal, and whole-grain barley without
                                added sugars, fats, oils, or salt (i.e.,
                                sodium). May be instant-, quick-, or
                                regular-cooking.
                               Soft corn or whole wheat tortillas may be
                                allowed at the State agency's option.
                                Whole grain must be the primary
                                ingredient by weight.
Canned fish \6\..............  Canned only:
                               Light tuna (must conform to FDA standard
                                of identity (21 CFR 161.190));
                               Salmon (must conform to FDA standard of
                                identity (21 CFR 161.170));
                               Sardines;
                               Mackerel (N. Atlantic Scomber scombrus,
                                or Chub Pacific Scomber japonicus);
                               May be packed in water or oil. Pack may
                                include bones or skin. May be regular or
                                lower in sodium content.\3\
Mature legumes (dry beans and  Any type of mature dry beans, peas, or
 peas).                         lentils in dry-packaged or canned \6\
                                forms. Examples include but are not
                                limited to black beans (``turtle
                                beans''), blackeye peas (cowpeas of the
                                blackeye variety, ``cow beans''),
                                garbanzo beans (chickpeas), great
                                northern beans, kidney beans, lima beans
                                (``butter beans''), navy beans, pinto
                                beans, soybeans, split peas, and
                                lentils. All categories exclude soups.
                                May not contain added sugars, fats, oils
                                or meat as purchased. Canned legumes may
                                be regular or lower in sodium content.\3
                                8\
                               Baked beans may be provided for
                                participants with limited cooking
                                facilities.\8\
Peanut butter................  Peanut butter and reduced fat peanut
                                butter (must conform to FDA Standard of
                                Identity (21 CFR 164.150)); creamy or
                                chunky, regular or reduced fat, salted
                                or unsalted \3\ forms are allowed.
Infant Foods:
    Infant cereal............  Infant cereal must contain a minimum of
                                45 mg of iron per 100 g of dry
                                cereal.\9\
    Infant fruits............  Any variety of single ingredient
                                commercial infant food fruit without
                                added sugars, starches, or salt (i.e.,
                                sodium). Texture may range from strained
                                through diced.\10\
    Infant vegetables........  Any variety of single ingredient
                                commercial infant food vegetables
                                without added sugars, starches, or salt
                                (i.e., sodium). Texture may range from
                                strained through diced.\11\

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    Infant meat..............  Any variety of commercial infant food
                                meat or poultry, as a single major
                                ingredient, with added broth or gravy.
                                Added sugars or salt (i.e. sodium) are
                                not allowed. Texture may range from
                                pureed through diced.\12\
------------------------------------------------------------------------
Table 4 Footnotes: FDA = Food and Drug Administration of the U.S.
  Department of Health and Human Services; RACC = reference amount
  customarily consumed.
\1\ The following are not considered a WIC eligible medical food:
  Formulas used solely for the purpose of enhancing nutrient intake,
  managing body weight, addressing picky eaters or used for a condition
  other than a qualifying condition (e.g., vitamin pills, weight control
  products, etc.); medicines or drugs, as defined by the Food, Drug and
  Cosmetic Act (21 U.S.C. 350a) as amended; enzymes, herbs, or
  botanicals; oral rehydration fluids or electrolyte solutions;
  flavoring or thickening agents; and feeding utensils or devices (e.g.,
  feeding tubes, bags, pumps) designed to administer a WIC-eligible
  formula.
\2\ All authorized milks must confirm to FDA, DHHS standards of identity
  for milks as defined by 21 CFR part 131 and meet WIC's requirements
  for vitamin fortification as stated above. Additional authorized milks
  include, but are not limited to: calcium-fortified, lactose-reduced
  and lactose-free, acidified, and UHT pasteurized milks. Other milks
  are permitted at the State agency's discretion provided that the State
  agency determines that the milk meets the minimum requirements for
  authorized milk.
\3\ Any of the folowing lower sodium forms are allowable:
Sodium-free--less than 5 mg sodium per serving;
Very low sodium--35 mg sodium or less per serving or, if the serving is
  30 g or less or 2 tablespoons or less, 35 mg sodium or less per 50 g
  of the food;
Low-sodium--140 mg sodium or less per serving or, if the serving is 30 g
  or less or 2 tablespoons or less, 140 mg sodium or less per 50 g of
  the food;
Light in sodium--at least 50 percent less sodium per serving than
  average reference amount for same food with no sodium reduction;
Lightly salted--at least 50 percent less sodium per serving than
  reference amount (If the food is not ``low in sodium,'' the statement
  ``not a low-sodium food'' must appear on the same panel as the
  Nutrition Facts panel.); and
Reduced or less sodium--at least 25 percent less sodium per serving than
  reference food.
\4\ Food and Drug Administration (FDA), Health Claim Notification for
  Whole Grain Foods with Moderate Fat Content at http://
  www.cfsan.fda.gov/dms/flgrain2.html
\5\ Herbs or spices; edible blossoms and flowers, e.g., squash blossoms
  (broccoli, cauliflower and artichokes are allowed); creamed or sauced
  vegetables; vegetable-grain (pasta or rice) mixtures; fruit-nut
  mixtures; breaded vegetables; fruits and vegetables for purchase on
  salad bars; peanuts; ornamental and decorative fruits and vegetables
  such as chili peppers on a string; garlic on a string; gourds; painted
  pumpkins; fruit baskets and party vegetable trays; and items such as
  blueberry muffins and other baked goods are not authorized. Mature
  legumes (dry beans and peas) and juices are provided as separate food
  WIC categories and are not authorized under the fruit and vegetable
  category.
\6\ ``Canned'' refers to processed food items in cans or other shelf-
  stable containers, e.g., jars, pouches.
\7\ Excludes white potatoes; catsup or other condiments; pickled
  vegetables, olives; soups; juices; and fruit leathers and fruit roll-
  ups.
\8\ The following canned mature legumes are not authorized: soups;
  immature varieties of legumes, such as those used in canned green
  peas, green beans, snap beans, orange beans, and wax beans; baked
  beans with meat; e.g., beans and franks; and beans containing added
  sugars (with the exception of baked beans), fats, meat, or oils.
\9\ Infant cereals containing infant formula, milk, fruit, or other non-
  cereal ingredients are not allowed.
\10\ Mixtures with cereal or infant food desserts (e.g., peach cobbler)
  are not authorized; however, combinations of single ingredients (e.g.,
  apple-banana) are allowed.
\11\ Combinations of single ingredients (e.g., peas and carrots) are
  allowed.
\12\ No infant food combinations (e.g., meat and vegetables) or dinners
  (e.g., spaghetti and meatballs) are allowed.

    (f) USDA purchase of commodity foods. (1) At the request of a State 
agency, FNS may purchase commodity foods for the State agency using 
funds allocated to the State agency. The commodity foods purchased and 
made available to the State agency must be equivalent to the foods 
specified in Table 4 of paragraph (e)(12) of this section.
    (2) The State agency must:
    (i) Distribute the commodity foods to its local agencies or 
participants; and
    (ii) Ensure satisfactory storage facilities and conditions for the 
commodity foods, including documentation of proper insurance.
    (g) Infant formula manufacturer registration. Infant formula 
manufacturers supplying formula to the WIC Program must be registered 
with the Secretary of Health and Human Services under the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Such manufacturers 
wishing to bid for a State contract to supply infant formula to the 
program must certify with the State health department that their 
formulas comply with the Federal Food, Drug, and Cosmetic Act and 
regulations issued pursuant to the Act.
    (h) Rounding up. State agencies may round up to the next whole 
container for either infant formula or infant foods (infant cereal, 
fruits, vegetables and meat). State agencies that use the rounding up 
option must calculate the amount of infant formula or infant foods 
provided according to the requirements and methodology as described in 
this section.
    (1) Infant Formula. State agencies must use the maximum monthly 
allowance of reconstituted fluid ounces of liquid concentrate infant 
formula as specified in Table 1 of paragraph (e)(9) of this section as 
the full nutritional benefit (FNB) provided by infant formula for each 
food package category and infant feeding option (e.g., Food Package I A 
fully formula fed, IA-FF).
    (i) For State agencies that use rounding up of infant formula, the 
FNB is determined over the timeframe (the number of months) that the 
participant receives the food package. In any given month of the 
timeframe, the monthly issuance of reconstituted fluid ounces of infant 
formula may exceed the maximum monthly allowance or fall below

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the FNB; however, the cumulative average over the timeframe may not fall 
below the FNB. In addition, the State agency must:
    (A) Use the methodology described in paragraph (h)(1)(ii) of this 
section for calculating and dispersing the rounding up option;
    (B) Issue infant formula in whole containers that are all the same 
size; and
    (C) Disperse the number of whole containers as evenly as possible 
over the timeframe with the largest monthly issuances given in the 
beginning of the timeframe.
    (ii) The methodology to calculate rounding up and dispersing infant 
formula to the next whole container over the food package timeframe is 
as follows:
    (A) Multiply the FNB amount for the appropriate food package and 
feeding option (e.g. Food Package I A fully formula fed, IA-FF) by the 
timeframe the participant will receive the food package to determine the 
total amount of infant formula to be provided.
    (B) Divide the total amount of infant formula to be provided by the 
yield of the container (in reconstituted fluid ounces) issued by the 
State agency to determine the total number of containers to be issued 
during the timeframe that the food package is prescribed.
    (C) If the number of containers to be issued does not result in a 
whole number of containers, the State agency must round up to the next 
whole container in order to issue whole containers.
    (2) Infant foods. (i) State agencies may use the rounding up option 
to the next whole container of infant food (infant cereal, fruits, 
vegetables and meats) when the maximum monthly allowance cannot be 
issued due to varying container sizes of authorized infant foods.
    (ii) State agencies that use the rounding up option for infant foods 
must:
    (A) Use the methodology described in paragraph (h)(2)(iii) of this 
section for calculating and dispersing the rounding up option;
    (B) Issue infant foods in whole containers; and
    (C) Disperse the number of whole containers as evenly as possible 
over the timeframe (the number of months the participant will receive 
the food package).
    (iii) The methodology to round up and disperse infant food is as 
follows:
    (A) Multiply the maximum monthly allowance for the infant food by 
the timeframe the participant will receive the food package to determine 
the total amount of food to be provided.
    (B) Divide the total amount of food provided by the container size 
issued by the State agency (e.g., ounces) to determine the total number 
of food containers to be issued during the timeframe that the food 
package is prescribed.
    (C) If the number of containers to be issued does not result in a 
whole number of containers, the State agency must round up to the next 
whole container in order to issue whole containers.
    (i) Plans for substitutions. (1) The State agency may submit to FNS 
a plan for substitution of food(s) acceptable for use in the Program to 
allow for different cultural eating patterns. The plan shall provide the 
State agency's justification, including a specific explanation of the 
cultural eating pattern and other information necessary for FNS to 
evaluate the plan as specified in paragraph (i)(2) of this section.
    (2) FNS will evaluate a State agency's plan for substitution of 
foods for different cultural eating patterns based on the following 
criteria:
    (i) Any proposed substitute food must be nutritionally equivalent or 
superior to the food it is intended to replace.
    (ii) The proposed substitute food must be widely available to 
participants in the areas where the substitute is intended to be used.
    (iii) The cost of the substitute food must be equivalent to or less 
than the cost of the food it is intended to replace.
    (3) FNS will make a determination on the proposed plan based on the 
evaluation criteria specified in paragraph (i)(2) of this section, as 
appropriate. The State agency shall substitute foods only after 
receiving the written approval of FNS.