[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\ [[Page 391]] 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 [[Page 392]] 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.