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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 7 - Agriculture |
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Subtitle B - Regulations of the Department of Agriculture |
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Chapter II - Food and Nutrition Service, Department of Agriculture |
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SubChapter A - Child Nutrition Programs |
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Part 246 - Special Supplemental Nutrition Program for Women, Infants and Children |
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Subpart D - Participant Benefits |
§ 246.10 - Supplemental foods.
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§ 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 table 4 of to paragraph (e)(12) of this section for the supplemental foods in their States, except that the State agency may not selectively choose which eligible fruits and vegetables are available to participants. These State agency criteria could address, but not be limited to, other nutritional standards, competitive cost, State-wide availability, and participant appeal. For eligible fruits and vegetables, State agencies may restrict packaging, e.g., plastic containers, and package sizes , such as single serving , of processed fruits and vegetables available for purchase with the cash-value voucher. In addition, State agencies may identify certain processed WIC-eligible fruits and vegetables on food lists where the potential exists for vendor or participant confusion in determining authorized WIC-eligible items.
(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.
(iii) Authorize package sizes, in addition to those authorized to fulfill paragraph (b)(2)(i) of this section, that increase participant variety and choice, except WIC formula, which must be authorized in sizes that correspond with the maximum monthly allowances per paragraphs (e)(9) and (11) of this section.
(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; all State agencies must authorize at least one package size (or combination of package sizes) that equal or add up to the maximum monthly allowances of all authorized supplemental foods in each of the food packages. State agencies must also provide to local agencies, and include in the State Plan, a list of acceptable foods and their maximum monthly allowances as specified in Tables tables 1 through 4 of to 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, inform participants about the maximum monthly allowances of authorized supplemental foods to which they are entitled as a Program participant and any food substitution options as specified in tables 1 through 3 to paragraphs (e)(9) through (11) of this section that the State agency authorizes, and abide by the authorized substitution rates for WIC food substitutions as specified in Tables tables 1 through 3 of to 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 nutritional and breastfeeding 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 § 246.7(m)(1)(i)(B), supplemental foods are not authorized for use in the preparation of meals served in a communal food service. This restriction does not preclude the provision or use of supplemental foods for individual participants in a nonresidential setting (e.g., child care facility, family day care home, school, or other educational program); a homeless facility that meets the requirements of § 246.7(m)(1); or, at the State agency's discretion, a residential institution (e.g., home for pregnant teens, prison, or residential drug treatment center) that meets the requirements currently set forth in § 246.7(m)(1) and (m)(2).
(c) Nutrition tailoring. Nutrition tailoring is the process of modifying an individual food package to better meet the supplemental nutritional needs of each participant. It entails making substitutions, reductions, and/or eliminations to food types and physical food forms in accordance with paragraphs (e)(9) through (11) of this section to accommodate special dietary needs, cultural practices, and/or personal preference. The full maximum monthly allowances of all supplemental foods in all food packages must be made available to participants if unless 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 or eliminations of foods cannot be made for categories, groups, or subgroups of WIC participants and may be done only after a nutrition assessment and offering substitution options available in the State in accordance with paragraphs (e)(9) through (11) and State agency policy. 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 chooses to take less than the maximum monthly allowance; or
(3) The quantities necessary to supplement another programsprogram's 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 an infant, child, or adult who receives Food Package III (see paragraph (e)(3) of this section);
(iii) Any exempt infant formula;
(iv) Any WIC-eligible nutritional;
(v) Any authorized supplemental food issued to participants who receive Food Package III; and
(vi) Any contract brand infant formula that does not meet the requirements in Table table 4 of to paragraph (e)(12) of this section.
(2) Medical documentation for other supplemental foods.
(i) State agencies may authorize local agencies to issue a non-contract brand infant formula that meets the requirements in Table table 4 of to 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 other than the primary contract infant formula and may decide that some contract brand infant formula may not be issued under any circumstances.
(3) Medical Determinationdetermination. For purposes of this program paragraph (d), 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)(1) through (e)(7) of this section that dictates the use of the supplemental foods, as described in paragraph (d)(1) of this section; and
(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 Requirementsrequirements —
(i) Location. All medical documentation must be kept on file (electronic or hard copy) at the local clinic. The medical documentation kept on file must include the initial telephone documentation, when received as described in paragraph (d)(4)(iii)(B) of this section.
(ii) Content. All medical documentation must include the following:
(A) The name of the authorized WIC formula (infant formula, exempt infant formula, WIC-eligible nutritional) 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)(1) 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, or 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-weeks' 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 participants. Breastfeeding assessment and the mother's plans for breastfeeding serve as the basis for determining food package issuance for all breastfeeding women. The intent of the WIC Program is that all breastfeeding women be supported to exclusively breastfeed their infants and to choose the fully breastfeeding food package without infant formula. Breastfeeding mothers whose infants receive formula from WIC are to be supported to breastfeed to the maximum extent possible with minimal supplementation with infant formula. Formula amounts issued to a breastfed infants infant are to be tailored to meet but not exceed the infant's nutritional needs. The seven food packages are as follows:
(1) Food Package I—Infants birth through 5 months —
(i) Participant category served. This food package is designed for issuance to infant participants infants from birth through age 5 months who do not have a condition qualifying them to receive Food Package III (see paragraph (e)(3) of this section). The following infant feeding variations are defined for the purposes of assigning food quantities and types in Food Packages I: Fully breastfeeding (the infant doesn't receive formula from the WIC Program); partially (mostly) breastfeeding (the infant is breastfed but also receives infant formula from WIC up to the maximum allowance described for partially (mostly) breastfed infants in Table table 1 of to paragraph (e)(9) of this section; and fully formula fed (the infant is not breastfed or is breastfed minimally (the infant receives infant formula from WIC in quantities that exceed those allowed for partially (mostly) breastfed infants).
(ii) Infant feeding age categories —
(A)Birth
to one month. Two infant food packages are available during the first month after birth—fully breastfeeding and fully formula-feeding. State agencies also have the option to make available a third food package containing not more than one can of powder infant formula in the container size that provides closest to 104 reconstituted fluid ounces to breastfed infants on a case-by-case basis. The infant receiving this food package is considered partially breastfeeding. State agencies choosing to make available a partially breastfeeding package in the first month may not standardize issuance of this food package. Infant formula may not be routinely provided during the first month after birth to breastfed infants in order to support the successful establishment of breastfeeding.(B) Onethrough 5 months. Three infant food packages are available from
1 monthsbirth through 5 months—fully breastfeeding, partially (mostly) breastfeeding, or fully formula-fed.
(iii) Infant formula requirements. This food package provides iron-fortified infant formula that is not an exempt infant formula and that meets the requirements in Table table 4 of to paragraph (e)(12) of this section. The issuance of any contract brand or noncontract brand infant formula that contains less than 10 milligrams of iron per liter (at least 1.5 milligrams iron per 100 kilocalories) at standard dilution is prohibited. Except as specified in paragraph (d) of this section, local agencies must issue as the first choice of issuance the primary contract infant formula, as defined in § 246.2, with all other infant formulas issued as an alternative to the primary contract infant formula. Noncontract brand infant formula and any contract brand infant formula that does not meet the requirements in Table table 4 of to paragraph (e)(12) of this section may be issued in this food package only with medical documentation of the qualifying condition. A health care professional licensed by the State to write prescriptions must make a medical determination and provide medical documentation that indicates the need for the infant formula. For situations that do not require the use of an exempt infant formula, such determinations include, but are not limited to, documented formula intolerance, food allergy or inappropriate growth pattern. Medical documentation must meet the requirements described in paragraph (d) of this section.
(iv) Physical forms. Local agencies must issue all WIC formulas (WIC formulas mean all infant formula, exempt infant formula and WIC-eligible nutritionals) 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 nutritionals are authorized only in Food Package III (see paragraph (e)(3) of this section). The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for infants in Food Packages I are stated in Table table 1 of to paragraph (e)(9) of this section.
(2) Food Package II—Infants 6 through 11 months —
(i) Participant category served. This food package is designed for issuance to infant participants infants from 6 through 11 months of age who do not have a condition qualifying them to receive Food Package III (see paragraph (e)(3) of this section).
(ii) Infant food packages. Three food packages for infants 6 through 11 months are available — fully available—fully breastfeeding, partially (mostly) breastfeeding, or fully formula fed.
(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 cereal, and infant foods are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for infants in Food Packages II are stated in Table table 1 of to paragraph (e)(9) of this section.
(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 children who have a documented qualifying condition that requires the use of a WIC formula (infant formula, exempt infant formula, or WIC-eligible nutritional) 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 -through VII (see paragraph (e)(4) through (7) of this section); 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 nutritionals) 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 apparatuses 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 WIC formula (infant formula, exempt infant formula, and WIC-eligible nutritionals), infant cereal, infant foods, milk, cheese, eggs, canned fish, fresh and other State-authorized forms of fruits and vegetables, breakfast cereal, whole wheat/whole grain bread, juice, and legumes and/or peanut butter. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for infants in Food Package III are stated in Table table 1 of to paragraph (e)(9) of this section. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for children and women in Food Package III are stated in Table table 3 of to paragraph (e)(11) of this section.
(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 nutritionals 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 nutritionals 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 nutritionals under Food Package III in situations where reimbursement is not provided by another entity.
(4) Food Package IV—Children IV-A and B—Children 1 through 4 years —
(i) Participant category served. This food package is designed for issuance to participants children 1 through 4 years of age who do not have a condition qualifying them to receive Food Package III (see paragraph (e)(3) of this section) and is divided into: Food Package IV-A for children 1 to less than 2 years of age (i.e., 12 through 23 months) and Food Package IV-B for children 2 years through 4 years of age.
(ii) Authorized categories of supplemental foods. Milk, breakfast cereal, juice, fresh and other State-authorized forms of fruits and vegetables, whole wheat/whole grain bread, eggs, and legumes or peanut butter, and canned fish are the categories of supplemental foods authorized in this food packagefor both Food Package IV-A and IV-B. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for children in Food Package IV Packages IV-A and IV-B are stated in Table table 2 of to paragraph (e)(10) of this section.
(5) Food Package V—Pregnant V-A and B—Pregnant and partially (mostly) breastfeeding women —
(i) Participant category categories served. This food package is designed for issuance to women participants with singleton pregnancies three categories of women who do not have a condition qualifying them to receive Food Package III . This food package is also designed for issuance to partially (mostly) breastfeeding women participants, (see paragraph (e)(3) of this section) and is divided into: Food Package V-A for issuance to women with singleton pregnancies and Food Package V-B for issuance to women pregnant with two or more fetuses and, for up to 1 year postpartum, who do not have a condition qualifying them to receive Food Package III and partially (mostly) breastfeeding women whose partially (mostly) breastfed infants receive formula from the WIC program Program in amounts that do not exceed the maximum allowances described in Table table 1 of to paragraph (e)(9) of this section. Women participants partially (mostly) breastfeeding more than one infant from the same pregnancy , and pregnant women fully or partially breastfeeding singleton infants , and women participants pregnant with two or more fetuses, are eligible to receive Food Package VII as described in paragraph (e)(7) of this section.
(ii) Authorized categories of supplemental foods. Milk, breakfast cereal, juice, fresh and other State-authorized forms of fruits and vegetables, whole wheat/whole grain bread, eggs, legumes and peanut butter, and canned fish are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for women in Food Package V Packages V-A and V-B are stated in Table table 2 of to paragraph (e)(10) of this section.
(6) Food Package VI—Postpartum women —
(i) Participant category categories served. This food package is designed for issuance to women up to 6 months postpartum who are not breastfeeding their infants, and to breastfeeding women up to 6 months postpartum whose participating infant receives more than the maximum amount of formula allowed for partially (mostly) breastfed infants as described in Table table 1 of to paragraph (e)(9) of this section , and who do not have a condition qualifying them to receive Food Package III (see paragraph (e)(3) of this section).
(ii) Authorized categories of supplemental foods. Milk, breakfast cereal, juice, fresh and other State-authorized forms of fruits and vegetables, whole wheat/whole grain bread, eggs, and legumes or peanut butter, and canned fish are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for women in Food Package VI are stated in Table table 2 of to paragraph (e)(10) of this section.
(7) Food Package VII—Fully breastfeeding —
(i) Participant category categories served. This food package is designed for issuance to breastfeeding women up to 1 year postpartum whose infants do not receive infant formula from WIC (these breastfeeding women are assumed to be exclusively breastfeeding their infants) , and who do not have a condition qualifying them to receive Food Package III (see paragraph (e)(3) of this section). This food package is also designed for issuance to women participants pregnant with two or more fetuses, women participants partially (mostly) breastfeeding multiple infants from the same pregnancy, and pregnant women who are also partially (mostly) breastfeeding singleton infants , and who do not have a condition qualifying them to receive Food Package III. Women participants fully breastfeeding multiple infants from the same pregnancy receive 1.5 times the supplemental foods provided in Food Package VII.
(ii) Authorized categories of supplemental foods. Milk, cheese, breakfast cereal, juice, fresh and other State-authorized forms of fruits and vegetables, whole wheat/whole grain bread, eggs, legumes , and peanut butter, and canned fish are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for women in Food Package VII are stated in Table table 2 of to paragraph (e)(10) of this section.
(8) Supplemental Foods—Maximum foods—Maximum monthly allowances, options and substitution rates, and minimum requirements. Tables 1 through 3 of to 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 to paragraph (e)(12) of this section describes the minimum requirements and specifications of supplemental foods in the WIC food packages.
(9) Full nutrition benefit and maximum monthly allowances supplemental foods for infants in Food Packages I, II, and III. Full nutrition benefit and maximum monthly allowances, options, and substitution rates of supplemental foods for infants in Food Packages I, II, and III (see paragraph (e)(1), (2), and (3) of this section) are stated in Table 1 table 1 to this paragraph (e)(9) as follows:
Table 1—Full 1 to Paragraph (e)(9)—Food Packages I, II, and III: Full Nutrition Benefit (FNB) and Maximum Monthly Allowances (MMA) of Supplemental Foods for Infants in Food Packages I, II and IIIby Feeding Option and Food Package Timeframe
Table 1 footnotes: (Foods1 Fully formula fed Formula Fed (FF) Partially (mostly) breastfed Breastfed (BF/FF) Fully breastfed Breastfed (BF) Food Packages I-FF
& III-FF
A: 0 through 3 months
B: 4 through 5 monthsFood Packages II-FF
& III-FF
6 through 11 monthsFood Packages I-BFIBF/FF & III BF/FF (
A: 0 to 1 month2 3) B: 1 through 3 months C
B: 4 through 5 monthsFood Packages II - BF/FF & III BF/FF
6 through 11 monthsFood
Package
I-BF
0 through 5 monthsFood
Package
II-BF
6 through 11 monthsWIC Formula 2 3 4 5 6 7 8 A: FNB = Up to 806 fl oz, . MMA= 823 fl oz, reconstituted liquid concentrate or 832 fl . oz . RTF or 870 fl oz reconstituted powder FNB = Up to 624 fl oz, . MMA = 630 fl oz , reconstituted liquid concentrate or 643 fl . oz RTF or 696 fl oz reconstituted powder A: 104 fl oz reconstituted powder B: FNB = Up to 364 fl oz, . MMA = 388 fl oz , reconstituted liquid concentrate or 384 fl oz RTF or 435 fl oz reconstituted powder FNB = Up to 312 fl oz, . MMA = 315 fl oz , reconstituted liquid concentrate or 338 fl oz RTF or 384 fl oz reconstituted powder N/A N/A. B: FNB = Up to 884 fl oz, . MMA = 896 fl oz , reconstituted liquid concentrate or 913 fl oz RTF or 960 fl oz reconstituted powder CB: FNB = Up to 442 fl oz, . MMA = 460 fl oz , reconstituted liquid concentrate or 474 fl oz RTF or 522 fl oz reconstituted powder Infant Cereal 9 10 11 24 oz 24 oz 24 N/A 8 oz N/A 8 oz N/A 16 oz. Infant food fruits and vegetables 9 10 11 12 13 N/A 128 oz N/A 128 oz256 N/A 128 oz. Infant food meat 9 77.5 oz. 10 N/A N/A N/A N/A N/A 40 oz. (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 Packages IV through VII (see paragraphs (e)(4) through (7) of this section) are stated in Table 2 table 2 to this paragraph (e)(10) as follows:
Table 2—Maximum Monthly Allowances 2 to Paragraph (e)(10)—Food Packages IV, V, VI, and VII: Maximum Monthly Allowances (MMA) of Supplemental Foods for Children and Women in Food Packages IV, V, VI and VII
Foods1 Children Women Food Package IV
A: 1 through 12 through 23 months
B: 2 through 4 yearsFood Package V
A: Pregnant and
B: Partially (Mostly) Breastfeeding
(up to 1 year postpartum)2Food Package VI :
Postpartum
(up to 6 months postpartum)3Food Package VII :
Fully Breastfeeding
(up to 1 year post-partum) 4 5Juice, single strength 6 128 7 64 fl oz144 64 fl oz96 64 fl oz 144 64 fl oz. Milk, fluid 16 qt7 8 9 10 11 22 qt7 8 9 10 12 16 qt7 8 9 10 12 24 qt7 8 9 10 12. Breakfast cereal13 12 13 14 15 A: 12 qt. 8 9 11 12 14
B: 14 qt.8 10 11 12 13 1416 qt.8 10 11 12 13 15 16 qt.8 10 11 12 13 15 16 qt.8 10 11 12 13 15 Breakfast cereal16 36 oz 36 oz 36 oz 36 oz. Cheese N/A N/A N/A 1 lb. Eggs Eggs17 1 dozen 1 dozen 1 dozen 2 dozen. Fresh fruits Fruits and vegetables 14 15 $8.00 in cash-value vouchers $10.00 in cash-value vouchers $10.00 in cash-value vouchers $10.00 in cash-value vouchers. 18 19 $24.00 CVV A: $43.00 CVV.
B: $47.00 CVV$43.00 CVV $47.00 CVV. Whole wheat or whole grain bread16 2 lb 1 lb N/A 1 lb20 24 oz 48 oz 48 oz 48 oz. Fish (canned) N/A N/A N/A 30 oz. Legumes, dry1721 22 6 oz A: 10 oz.
B: 15 oz10 oz 20 oz. Mature Legumes and/or Peanut butter23 1 lb dry or 64 oz canned Or 18 oz 1 lb and dry or 64 oz canned And 18 oz 1 lb dry or 64 oz canned Or 18 oz 1 lb and dry or 64 oz canned And 18 oz. (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 table 3 to this paragraph (e)(11) as follows:
Table 3—Maximum 3 to Paragraph (e)(11)—Food Package III: Maximum Monthly Allowances (MMA) of Supplemental Foods for Children and Women With Qualifying Conditions in Food Package III
Foods1 Children Women 1 through A: 12 through 23 months
B: 2 through 4 yearsPregnant and partially breastfeeding (A: Pregnant
B: Partially (Mostly) Breastfeeding (up to 1 year postpartum)2Postpartum
(up to 6 months postpartum)3Fully breastfeeding, Breastfeeding
(up to 1 year post-partumpostpartum) 4 5Juice, single strength 6 128 7 64 fl oz144 64 fl oz96 64 fl oz 144 64 fl oz. WIC Formula7formula 8 9 Up to 455 fl oz liquid concentrate Up to 455 fl oz liquid concentrate Up to 455 fl oz liquid concentrate Up to 455 fl oz liquid concentrate. Milk, fluid 10 11 12 13 14 15 16 17 A: 12 qt9. 10 11 13 14 16.
B: 14 qt.10 12 1322 qt910111214 16 qt910111214 24 qt910111214. Breakfast cereal1516 14 15 16 16 qt. 10 12 13 14 15 17 16 qt. 10 12 13 14 15 17 16 qt. 10 12 13 14 15 17 Breakfast cereal 18 19 36 oz 36 oz 36 oz 36 oz. Cheese N/A N/A N/A 1 lb. Eggs Eggs 20 1 dozen 1 dozen 1 dozen 2 dozen. Fruits and vegetables 171819 $8.00 in cash-value vouchers $10.00 in cash-value vouchers $10.00 in cash-value vouchers $10.00 in cash-value vouchers. 21 22 23 $24.00 CVV A: $43.00 CVV.
B: $47.00 CVV$43.00 CVV 47.00 CVV. Whole wheat or whole grain bread 20 2 lb 1 lb N/A 1 lb24 24 oz 48 oz 48 oz 48 oz. Fish (canned) N/A N/A N/A 30 oz. Legumes, dry2125 26 6 oz A: 10 oz.
B: 15 oz10 oz 20 oz. Mature Legumes
and/or
Peanut butter 271 lb dry or 64 oz canned
Or
18 oz1 lb and dry or 64 oz canned
And
18 oz1 lb dry or 64 oz canned
Or
18 oz1 lb and dry or 64 oz canned
And
18 oz.(12) Minimum requirements and specifications for supplemental foods. Table 4 to this paragraph (e)(12) describes the minimum requirements and specifications for supplemental foods in all food packages:
Table 4—Minimum 4 to Paragraph (e)(12)—Minimum Requirements and Specifications for Supplemental Foods
Categories/foods Minimum requirements and specifications WIC FORMULAFormula: Infant formulaFormula All authorized infant formulas must: (1) Meet the definition for an infant formula in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and meet the requirements for an infant formula under section 412 of the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 350a), and the regulations at 21 CFR parts 106 and 107; (2) Be designed for enteral digestion via an oral or tube feeding; (3) Provide at least 10 mg iron per liter (at least 1.5 mg iron/100 kilocalories) at standard dilution; (4) Provide at least 67 kilocalories per 100 milliliters (approximately 20 kilocalories per fluid ounce) at standard dilution. ; and (5) Not require the addition of any ingredients other than water prior to being served in a liquid state. Exempt infant formulaInfant 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 nutritionals.Nutritionals1 Certain enteral products that are specifically formulated and commercially manufactured (as opposed to a naturally occurring foodstuff used in its natural state) to provide nutritional support for individuals with a qualifying condition, when the use of conventional foods is precluded, restricted, or inadequate. Such WIC-eligible nutritionals must serve the purpose of a food, meal, or diet (may be nutritionally complete or incomplete) and provide a source of calories and one or more nutrients; be designed for enteral digestion via an oral or tube feeding; and may not be a conventional food, drug, flavoring, or enzyme. MILK AND MILK ALTERNATIVESMilk, Milk Alternatives, and Milk Substitutions: Cow's milkMilk2 Must conform to FDA standard Standard of identity Identity for whole, reduced-fat, lowfatlow-fat, or nonfat milks (21 CFR 131.110). Must be pasteurized. May be flavored or unflavoredOnly unflavored milk is permitted. May be fluid, shelf-stable, evaporated (21 CFR 131.130), or dry. Dry whole milk must conform to FDA standard Standard of identity Identity (21 CFR 131.147). Nonfat dry milk must conform to FDA standard Standard of identity Identity (21 CFR 131.127). Cultured milks must conform to FDA standard Standard of identity Identity for cultured milk, e.g., cultured buttermilk, kefir cultured milk, acidophilus cultured milk (21 CFR 131.112). Acidified milk must conform to FDA standard Standard of identity Identity for acidified milk, e.g., acidified kefir milk, acidified acidophilus milk or acidified buttermilk (21 CFR 131.111). All Whole, reduced-fat, lowfatlow-fat, and nonfat cow's milk types and varieties must contain at least 400 IU of vitamin D per quart (100 IU per cup) and 2000 2,000 IU of vitamin A per quart (500 IU per cup). Goat's milkMilk Must be pasteurized. May be flavored or unflavoredOnly unflavored milk is permitted. May be fluid, shelf-stable, evaporated, or dry (i.e., powdered). All Whole, reduced-fat, lowfatlow-fat, and nonfat goat's milk must contain at least 400 IU of vitamin D per quart (100 IU per cup) and 2000 2,000 IU of vitamin A per quart (500 IU per cup). Plant-based Milk Alternatives Must contain ≤10 g of added sugars per cup and be fortified to meet the following nutrient levels (amounts are provided per cup): 276 mg calcium, 8 g protein, 500 international units vitamin A, 100 IU (2.5 micrograms) vitamin D, 24 mg magnesium, 222 mg phosphorus, 349 mg potassium, 0.44 mg riboflavin, and 1.1 mcg vitamin B12, in accordance with FDA-issued fortification guidelines. May be flavored or unflavored. Cheese Domestic cheese made from 100 percent pasteurized milk. Must conform to FDA standard Standard of identity Identity (21 CFR part 133); Monterey Jack, Colby, natural Cheddar, Swiss, Brick, Muenster, Provolone, part-skim or whole Mozzarella, pasteurized process American, or blends of any of these cheeses are authorized. Cheeses that are labeled low, free, reduced, less or light in sodium, fat or cholesterol are WIC-eligible. Plant-based Cheese Alternatives Must contain a minimum of 250 mg of calcium and 6.5 g of protein per 1.5 ounces. Plant-based curd cheeses are not authorized. Yogurt (cow's milk) Yogurt must Must be pasteurized and , conform to FDA standard of identity for whole fat Standard of Identity (21 CFR 131.200) , lowfat (21 CFR 131.203), or nonfat (21 CFR 131.206); plain or flavored with ≤40 g of total sugars per 1 cup yogurtand contain ≤16 grams of added sugar and a minimum of 106 IU (2.67 micrograms) of vitamin D per 8 ounces. May be plain or flavored. Yogurts that are fortified with vitamin A and D and other nutrients may be allowed at the State agency's option. Yogurts sold with accompanying mix-in ingredients such as granola, candy pieces, honey, nuts, and similar ingredients are not authorized. Drinkable yogurts are not authorized. Tofu Calcium-set tofu prepared with calcium salts (e.g., calcium sulfate). May not contain added fats, sugars, oils, or sodium. Tofu must be calcium-set, i.e., contain calcium salts, but may also contain other coagulants, i.e., magnesium chloride. Soy-based beverage Must be fortified to meet the following nutrient levels: 276 mg calcium per cup, 8 g protein per cup, 500 IU vitamin A per cup, 100 IU vitamin D per cup, 24 mg magnesium per cup, 222 mg phosphorus per cup, 349 mg potassium per cup, 0.44 mg riboflavin per cup, and 1.1 mcg vitamin B12 per cup, in accordance with fortification guidelines issued by FDA. May be flavored or unflavored. JUICE Must be pasteurized 100%Plant-based Yogurt Alternatives Must contain ≤16 g of added sugars and a minimum of 250 mg of calcium, 6.5 g of protein, and 106 IU (2.67 micrograms) of vitamin D per 8 ounces. May be plain or flavored. Plant-based yogurts sold with accompanying mix-in ingredients such as granola, candy pieces, honey, nuts, and similar ingredients are not authorized. Drinkable yogurts are not authorized. Tofu Must contain a minimum of 100 mg of calcium per 100 g of tofu. May not contain added fats, sugars, oils, or sodium. Juice Must be pasteurized 100 percent unsweetened fruit juice. Must contain at least 30 mg of vitamin C per 100 mL of juice. Must conform to FDA standard Standard of identity Identity as appropriate (21 CFR part 146) or vegetable juice must conform to FDA standard Standard of identity Identity as appropriate (21 CFR part 156). With the exception of 100% Except for 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. Blends of authorized juices are allowed. Vegetable juice may be regular or lower in sodium. EGGS Eggs Fresh shell domestic hens' eggs or dried eggs mix (must conform to FDA standard Standard of identity Identity in 21 CFR 160.105) or pasteurized liquid whole eggs (must conform to FDA standard Standard of identity Identity in 21 CFR 160.115). Hard boiled eggs, where readily available for purchase in small quantities, may be provided for homeless participants. BREAKFAST CEREAL Breakfast Cereal (READYReady-TO-EAT AND INSTANT AND REGULAR HOT CEREALSto-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 of added sugar per 100 g dry cereal (≤6 g per dry oz). At least half of the cereals authorized on a State agency's .)Seventy five percent of cereals on the State agency authorized food list must have contain whole grain as the primary ingredient by weight AND meet labeling requirements for making a health claim as a “whole grain food with moderate fat content”.3 FRUITS AND VEGETABLES (FRESH AND PROCESSED)4 5 6 8 9 first ingredient. Fruits and vegetables (fresh and processed) 3 4 5 6 7 Any variety of fresh (as defined by 21 CFR 101.95) whole or cut fruit without added sugars.
Any variety of fresh (as defined by 21 CFR 101.95) whole or cut vegetable , except white potatoes, without added sugars, fats, or oils (orange yams and sweet potatoes are allowed).Any variety of canned fruits (must conform to FDA standard of identity as appropriate (21 CFR part 145)); including applesauce, juice pack or water pack without added sugars, fats, oils, or salt (i.e., sodium). The fruit must be listed as the first ingredient. Any variety of frozen fruits without added sugars, fats, oils, or salt (i.e., sodium). Any variety of canned or frozen vegetables , except white potatoes (orange yams and sweet potatoes are allowed); without added sugars, fats, or oils. Vegetable must be listed as the first ingredient. May be regular or lower in sodium. Must conform to FDA standard of identity as appropriate (21 CFR part 155). Any type of dried fruits or dried vegetable, except white potatoes (orange yams and sweet potatoes are allowed); vegetables without added sugars, fats, oils, or salt (i.e., sodium). Any type of immature beans, peas, or lentils, fresh or in canned5 4 forms. Any type of frozen beans (immature or mature). Beans purchased with the CVV may contain added vegetables and fruits, but may not contain added sugars, fats, oils, or meat as purchased. Canned beans, peas, or lentils may be regular or lower in sodium content. State agencies must allow organic forms of WIC-eligible fruits and vegetables. WHOLE WHEAT BREAD, WHOLE GRAIN BREAD, AND WHOLE GRAIN OPTIONSWhole Wheat Bread, Whole Grain Bread, and Whole Grain Options: Bread Whole wheat bread must conform to FDA standard Standard of identity Identity (21 CFR 136.180). (Includes whole wheat buns and rolls.) “Whole wheat flour” and/or “bromated whole wheat flour” must be the only flours listed in the ingredient list. OR Whole grain bread must conform to FDA standard Standard of identity Identity (21 CFR 136.110) (includes whole grain buns and rolls) . AND Whole grain must be the primary ingredient by weight in all whole grain bread products. AND Must meet FDA labeling requirements for making a health claim as a “whole grain food with moderate fat content”.3 AND Must contain at least 50 percent whole grains with the remaining grains being either enriched or whole grains.8 Whole Grain Options Brown rice, wild rice, quinoa, bulgur (cracked wheat), oats, and whole-grain barley, millet, triticale, amaranth, cornmeal (including blue), corn masa flour, whole wheat macaroni (pasta) products, whole wheat bread products (i.e., pita, English muffin, bagels, naan), soft corn or whole wheat tortillas, buckwheat, teff, kamut, sorghum, wheat berries without added sugars, fats, oils, or salt (i.e., sodium). May be instant-, quick-, or regular-cooking. State agencies have the option to authorize other intact whole grain options without added sugars, fats, oils, or salt (i.e., sodium). Corn meal (including blue) must conform to FDA Standard of Identity 21 CFR 137.260 & aligning with USDA School Meal Guidance. Soft corn or whole wheat tortillas. Soft corn tortillas made from ground masa flour (corn flour) using traditional processing methods are WIC-eligible, e.g., whole corn, corn (masa), whole ground corn, corn masa flour, masa harina, and white corn flour. For whole wheat tortillas, “whole wheat flour” must be the only flour listed in the ingredient list. States may offer tortillas made with folic acid-fortified corn masa flour. Whole wheat macaroni (pasta) products. Must conform to FDA standard Standard of identity Identity (21 CFR 139.138) and have no added sugars, fats, oils, or salt (i.e., sodium). “Whole wheat flour” and/or “whole durum wheat flour” must be the only flours listed in the ingredient list. Other shapes and sizes that otherwise meet the FDA standard Standard of identity Identity for whole wheat macaroni (pasta) products (21 CFR 139.138), and have no added sugars, fats, oils, or salt (i.e., sodium), are also authorized allowed (e.g., whole wheat rotini, and whole wheat penne). FISH Fish (CANNED)5 Canned only: canned)4 Light tuna (must conform to FDA standard Standard of identity Identity (21 CFR 161.190)); Salmon (Pacific salmon must conform to FDA standard of identity (21 CFR 161.170)); Sardines; and Mackerel (N. Atlantic Scomber scombrus;, Chub Pacific Scomber japonicas; Jack Mackerel10)9 May be packed in water or oil. Pack may include bones or skin. Only boneless varieties of fish may be provided to children at State agency option. Added sauces and flavorings, e.g., tomato sauce, mustard, lemon, are authorized at the State agency's option. May be regular or lower in sodium content. MATURE LEGUMES (DRY BEANS AND PEAS)7 Mature Legumes, Peanut Butter, and Peanut Butter Substitutions: Mature Legumes (dry beans and peas)10 Any type of mature dry beans, peas, or lentils in dry-packaged or and canned5 4 forms. Examples include but are not limited to black beans, black-eyed peas, garbanzo beans (chickpeas), great northern beans, white beans (navy and pea beans), kidney beans, mature lima (“butter beans”), fava and beans, mung beans, pinto beans, soybeans/edamame, split peas, lentils, and refried beans. Does not include green beans or green peas. All categories exclude soups. May not contain added sugars, fats, oils, vegetables, fruits, or meat as purchased. Canned legumes may be regular or lower in sodium content.11 Baked beans may only be provided for participants with limited cooking facilities.11 PEANUT BUTTER Peanut Butter Peanut butter and reduced-fat peanut butter ( must conform to FDA Standard of Identity (21 CFR 164.150)); creamy or chunky, regular, or reduced-fat, salted or unsalted forms are allowed. Peanut butters with added marshmallows, honey, jelly, chocolate, or similar ingredients are not authorized. INFANT FOODS Nut and Seed Butters Must provide comparable nutritive value to peanut butter (i.e., protein and iron). May be creamy or chunky, regular, or reduced-fat, salted or unsalted forms are allowed. Nut and seed butter with added marshmallows, honey, jelly, chocolate, or similar ingredients are not authorized. Infant Foods: Infant Cereal Infant cereal must contain a minimum of 45 mg of iron per 100 g of dry cereal.12 Infant Fruits Any variety of single ingredient commercial infant food fruit without added sugars, starches, or salt (i.e., sodium). Texture may range from strained through diced. The fruit must be listed as the first ingredient.13 Infant Vegetables Any variety of single ingredient commercial infant food vegetables without added sugars, starches, or salt (i.e., sodium). Texture may range from strained through diced. The vegetable must be listed as the first ingredient.14 Infant Meat Any variety of commercial infant food meat or poultry , as a single major ingredient, with added broth or gravy. Added sugars or salt (i.e., sodium) are not allowed. Texture may range from pureed through diced.15 (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 table 4 of to 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 Program must certify with the State health department that their formulas comply with the Federal Food, Drug, and Cosmetic Act and regulations in this chapter 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 Formulaformula. State agencies must use the maximum monthly allowance of reconstituted fluid ounces of liquid concentrate infant formula as specified in Table table 1 of to 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 IA fully formula fed, IA-FF (see paragraph (e)(1) of this section)).
(i) For State agencies that use rounding up of infant formula, the FNB is determined over the timeframe (the number of months) that the participant receives the food package. In any given month of the timeframe, the monthly issuance of reconstituted fluid ounces of infant formula may exceed the maximum monthly allowance or fall below the FNB; however, the cumulative average over the timeframe may not fall below the FNB without individual tailoring to allow “up to” amounts to support breastfeeding. 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 IA fully formula fed, IA-FF (see paragraph (e)(1) of this section)) 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 meatsmeat) 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 cultural substitutions.
(1) The State agency may submit to FNS a plan for substitution of food(s) acceptable for use in the Program in addition to the supplemental foods outlined in (see paragraph (e)(12) of this section) 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 assessed and comparable to 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.
[50 89 FR 612128518, FebApr. 13, 1985, as amended at 73 FR 11312, Mar. 3, 2008; 74 FR 48845, Sept. 25, 2009; 74 FR 69245, Dec. 31, 2009; 79 FR 12290, Mar. 4, 2014; 79 FR 15625, Mar. 20, 201418, 2024]