Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages, 12273-12300 [2014-04105]

Download as PDF Vol. 79 Tuesday, No. 42 March 4, 2014 Part II Department of Agriculture mstockstill on DSK4VPTVN1PROD with RULES2 Food and Nutrition Service 7 CFR Part 246 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages; Final Rule VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\04MRR2.SGM 04MRR2 12274 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF AGRICULTURE Anne Bartholomew, Chief, Nutrition Services Branch, Supplemental Food Programs Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 522, Alexandria, Virginia 22302, (703) 305–2746 OR ANNE.BARTHOLOMEW@ FNS.USDA.GOV. Food and Nutrition Service 7 CFR Part 246 [FNS–2006–0037] RIN 0584–AD77 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages SUPPLEMENTARY INFORMATION: Food and Nutrition Service (FNS), USDA. ACTION: Final rule. AGENCY: This final rule considers public comments submitted in response to the interim rule revising the WIC food packages published on December 6, 2007. The interim rule implemented the first comprehensive revisions to the WIC food packages since 1980. The interim rule revised regulations governing the WIC food packages to align them more closely with updated nutrition science and the infant feeding practice guidelines of the American Academy of Pediatrics, promote and support more effectively the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. This rule makes adjustments that improve clarity of the provisions set forth in the interim rule. DATES: Effective Date: This rule is effective May 5, 2014. Implementation Dates: • State agencies must implement the provision in Table 2 at 7 CFR 246.10(e)(10) increasing the cash-value voucher for children to $8 per month no later than June 2, 2014. • The provision found at 7 CFR 246.12(f)(4) requiring split tender for cash-value vouchers shall be implemented no earlier than October 1, 2014 and no later than April 1, 2015. • Footnote 11 of Table 2 at 7 CFR 246.10(e)(10) shall be implemented on the later of October 1, 2014, or the date on which the State agency exercises their option to issue authorized soybased beverage or tofu to children who receive Food Package IV. • The provisions in Footnote 10 of Table 2 at 7 CFR 246.10(e)(10) and Footnote 12 of Table 3 at 7 CFR 246.10(e)(11) authorizing yogurt for children and women in Food Packages III–VII may be implemented no earlier than April 1, 2015. mstockstill on DSK4VPTVN1PROD with RULES2 SUMMARY: VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 I. Overview This final rule addresses public comments submitted in response to the interim rule revising the WIC food packages published on December 6, 2007 (72 FR 68966), and makes adjustments that improve clarity of the provisions set forth in the interim rule. II. Background An interim rule revising the WIC food packages was published in the Federal Register on December 6, 2007 (72 FR 68966). The interim rule implemented the first comprehensive revisions to the WIC food packages since 1980 and largely reflected recommendations made by the National Academies’ Institute of Medicine (IOM) in its Report ‘‘WIC Food Packages: Time for a Change’’ (‘‘Report’’).1 The interim rule aligned the food packages more closely with updated nutrition science, promoted and supported more effectively the establishment of successful long-term breastfeeding, provided WIC participants with a wider variety of food, and provided WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. WIC State agencies were required to implement the changes by October 1, 2009. III. General Summary of Comments Received on the Interim Rule To Revise the WIC Food Packages The interim rule revising the WIC food packages provided an extensive public comment period to obtain comments on the impact of the changes experienced during implementation of the new food packages. The interim rule comment period ended February 1, 2010. A total of 7,764 comment letters were received on the interim rule; of those, 111 were form letters. A total of 6,664 of the letters were from program participants, and included comments submitted in Spanish, Chinese, and other languages, in addition to English. 1 Institute of Medicine, National Academy of Sciences. ‘‘WIC Food Packages: Time for a Change,’’ 2005. Available at Internet site: https:// www.fns.usda.gov/wic-food-packages-time-change. PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 The remaining comment letters were submitted from a variety of sources, including WIC State and local agencies and Indian Tribal Organizations, the National WIC Association (NWA), professional organizations and associations, advocacy groups, healthcare professionals (including universities), members of Congress, the food industry, vendors, farmers, and private citizens. In general, commenters expressed broad support for the changes and reported relatively smooth implementation of the new WIC food packages. Commenters also voiced concerns about various aspects of the interim rule and made recommendations for clarifying or improving specific provisions of the interim rule. Overall, participants expressed overwhelming support for the revised WIC food packages, especially the addition of whole grains and fruits and vegetables. However, many participants who were enrolled in WIC during the transition from the previous food packages to the revised food packages expressed displeasure with changes to fat-reduced milks and less cheese. FNS considered all timely comments without regard to whether they were provided by a single commenter or repeated by many. Importance was given to the substance or content of the comment, rather than the number of times a comment was submitted. WIC State agencies are to be commended for the staff and vendor training that led to successful implementation of the new WIC food packages, as well as nutrition education provided to participants on the benefits of the new foods in the WIC food packages. Successful implementation of the new WIC food packages was further enhanced by the efforts of WIC’s partners in the advocacy, retail, and medical communities. IV. Discussion of the Final Rule Provisions The following is a discussion of the major provisions set forth in this final rule, a brief summary of the comments received on the interim rule that addressed these issues, and FNS’ rationale for either modifying or retaining provisions in this final rule. Provisions not addressed in the preamble to this final rule did not receive significant or substantial public comments and remain unchanged. The preamble to this final rule articulates the basis and purpose behind significant changes from the December 6, 2007 interim rule. The reasons supporting provisions of the interim E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations regulations were carefully examined in light of the comments received to determine the continued applicability of the justifications. Unless otherwise stated, or unless inconsistent with this final rule or this preamble, the rationales contained in the preamble to the proposed and interim regulations should be regarded as the basis for this final rule. Therefore, a thorough understanding of the rationales for the interim regulations may require reference to the preamble of the August 7, 2006 proposed rule (71 FR 44784) and the December 6, 2007 interim rule (72 FR 68966). mstockstill on DSK4VPTVN1PROD with RULES2 A. Definitions The following definitions have been added or modified in the final rule. Farmers’ market. As described in a subsequent section of this preamble, this final rule adds the definition of ‘‘farmers’ markets’’ at 7 CFR 246.2. Full nutrition benefit. As described in a subsequent section of this preamble, this final rule adds the definition of ‘‘full nutrition benefit’’ at 7 CFR 246.2. WIC-eligible medical foods. Based on review and discussion with the Food and Drug Administration (FDA), this final rule changes the name of the food category ‘‘WIC-eligible medical food’’ to ‘‘WIC-eligible nutritionals,’’ but does not substantively change this food category. This nomenclature modification better describes the group of special WIC-eligible nutritional products the WIC Program provides to participants with qualifying conditions, and alleviates confusion associated with the use of the term ‘‘medical food,’’ which is defined by regulations governing FDA and differs from the WIC use of this term. The FNS definition for ‘‘WIC-eligible medical food’’ and the FDA definition for ‘‘medical food’’ are both comprehensive and detailed. Although the definition of ‘‘WIC-eligible medical food’’ closely aligns with the FDA definition for ‘‘medical food,’’ there are slight differences, such that some, but not all ‘‘WIC-eligible medical foods’’ meet FDA’s definition of ‘‘medical food.’’ In an effort to alleviate confusion, and distinguish between the two product categories and definitions, FNS is modifying the name of the food category from ‘‘WIC-eligible medical food’’ to ‘‘WIC-eligible nutritionals.’’ Other than the name change, the definition for this food category put forth in the interim rule remains unchanged in this final rule. VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 B. General Provisions That Affect All WIC Food Packages 1. Nutrition Tailoring Prior to the interim rule, FNS policy allowed both categorical and individual nutrition tailoring of WIC food packages. Categorical nutrition tailoring is the process of modifying the WIC food packages for participant groups or subgroups with similar supplemental nutrition needs, based on scientific nutrition rationale, public health concerns, cultural eating patterns, and State established policies. The interim rule prohibits categorical nutrition tailoring, but continues to allow individual nutrition tailoring based on the Competent Professional Authority’s (CPA) assessment of a participant’s supplemental nutrition needs. A total of 33 commenters (of these, 8 were form letters) opposed the provision that prohibits categorical tailoring, stating that State agencies need the flexibility to propose modifications to food packages that respond to rapid changes in food industry, science, dietary recommendations, demographics, and other factors. Commenters asked that State agencies be able to request approval for categorical tailoring to meet nutritional needs and preferences. As stated in the preamble to the interim rule, the IOM conducted a full, independent and rigorous scientific review of the nutritional needs of WIC participants prior to recommending the quantities and types of WIC foods to address those needs in its Report. In addition, Section 232 of Public Law 111–296 amended Section 17(f)(11)(C) of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by requiring the Secretary to conduct, as often as necessary, but not less than every 10 years, a scientific review of supplemental foods available under the program and to amend the foods, as needed, to reflect nutrition science, public health concerns, and cultural eating patterns. As such, future reviews of the WIC food packages by FNS will be conducted as needed and used to determine the need for modification of current WIC food packages. FNS believes that this is the appropriate process for changes to the WIC food packages and that State agencies will best be able to meet the nutritional needs of each WIC participant through nutrition assessment and individual tailoring of the food package. Therefore, the provision to disallow State agency proposals to categorically tailor WIC food packages is retained in this final rule at 7 CFR 246.10(c). PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 12275 2. Cultural Food Package Proposals The interim rule allows State agencies to submit to FNS a plan for substitution of food(s) to allow for different cultural eating patterns. The interim rule includes criteria for submitting plans for substitutions and the criteria FNS will use to evaluate such plans. A total of 26 commenters (8 form letters) asked FNS to change the criterion that ‘‘any proposed substitute food must be nutritionally equivalent or superior to the food it is intended to replace’’ to be less restrictive and easier to satisfy. The increased variety and choice in the supplemental foods in the interim rule, as recommended by the IOM, provide State agencies expanded flexibility in prescribing culturally appropriate packages for diverse groups. Further, the interim rule allows State agencies flexibility to meet unanticipated cultural needs of participants by submitting plans for substitutions. The criteria are not meant to preclude justifiable cultural substitution proposals submitted by WIC State agencies, but are intended to ensure that WIC food substitutions maintain the nutritional integrity of the WIC foods they replace. FNS will continue to make determinations on proposed plans for cultural substitutions based on existing evaluation criteria as appropriate. Therefore, the criteria for submitting State agency plans for substitutions for different cultural eating patterns and the criteria FNS will use to evaluate such plans are retained at 7 CFR 246.10(i). The interim rule increased the variety and number of substitutions available for several WIC foods. This final rule further increases the number of substitutions and options available, i.e., yogurt, canned jack mackerel, and whole wheat macaroni (pasta) products. These additions are within the context of the IOM recommendations. FNS believes that these changes already provide substantial flexibility for prescribing food packages and that further modifications of the current WIC food packages are best determined through future scientific reviews of the WIC food packages. FNS will, therefore, not accept WIC State agency plans for substitutions of WIC foods for reasons other than to accommodate cultural eating patterns as provided for in 7 CFR 246.10(i). 3. Medical Documentation and Supervision Requirements a. Milk and Milk Alternatives Under the interim rule, medical documentation by a health care professional licensed to write medical E:\FR\FM\04MRR2.SGM 04MRR2 mstockstill on DSK4VPTVN1PROD with RULES2 12276 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations prescriptions is required for the issuance of certain milk alternatives for children and women. A total of 180 comment letters (53 of these form letters) opposed this requirement, primarily the documentation for children to receive soy-based beverage. Commenters stated that the provision is unnecessary, costly and burdensome for participants and physicians, creates barriers to services, and undermines FNS’ efforts to provide foods that meet the cultural needs of participants. The NWA and the American Dietetic Association (now known as the Academy of Nutrition and Dietetics) stressed that WIC dietitians and nutritionists are trained health professionals capable of doing a complete nutrition assessment, selecting WIC foods, and providing appropriate education to participants and caregivers, in consultation with the health care provider when warranted. Based on the experiences cited by WIC State and local agencies related to medical documentation throughout implementation of the new food packages, FNS will no longer require a health care professional licensed to write medical prescriptions to provide documentation for children to receive soy-based beverage and tofu as milk substitutes. Also, FNS will no longer require documentation from a health care professional licensed to write medical prescriptions for women to receive tofu in excess of the maximum substitution allowance. Instead, consistent with IOM recommendations for documentation from a ‘‘WIC recognized medical authority,’’ FNS will allow the CPA to determine and document the need for tofu and soybased beverage as substitutes for milk for children, as established by State agency policy. Such determination must be based on individual nutritional assessment, as required under the interim rule and retained in this final rule at 7 CFR 246.10(b)(2)(ii)(C), and consultation with the participant’s health care provider, as appropriate. Such determination can be made for situations that include, but are not limited to, milk allergy, lactose intolerance, and vegan diets. As previously discussed, the interim rule revised regulations governing the WIC food packages to, among other things, accommodate participants with cultural food preferences. Since cultural practices may affect nutrient intake, FNS will allow soy for cultural practices that prevent participants from including in their diets cow’s milk and lactose-free or lactose-reduced fortified dairy VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 products in amounts that meet their nutritional needs. FNS will allow the CPA, as established by State agency policy, to determine the need for tofu in quantities that exceed the maximum substitution rates. Such determination can be made for situations that include, but are not limited to, milk allergy, lactose intolerance, and vegan diets. FNS believes that allowing the CPA to make determinations for milk substitutes is consistent with IOM recommendations for documentation from a ‘‘WIC recognized medical authority.’’ Although FNS is no longer requiring documentation from a health care professional licensed to write medical prescriptions, it is incumbent upon WIC State agencies to ensure that participants and caregivers receive education that stresses the importance of milk over milk substitutes, and that appropriate policies and procedures are in place for appropriate issuance of milk substitutes. Parents and caregivers should be made aware that children’s diets may be nutritionally inadequate when milk is replaced by other foods, and provided appropriate nutrition education. The value of milk for WIC participants, particularly in the development of bone mass for children, should be emphasized. Lactose-free or lactose-reduced fortified dairy products should be offered before non-dairy milk alternatives to those participants with lactose intolerance that cannot drink milk. Also, if milk is replaced by milk alternatives that are not vitamin D fortified, vitamin D intakes may be inadequate. Thus, replacements for milk are to be approached with caution even if they are rich in calcium. Therefore, Table 2 of 7 CFR 246.10(e)(10) of this final rule requires that issuance of tofu and soy-based beverage as substitutes for milk for children be based on an individual nutritional assessment by the CPA, in consultation with the participant’s health care provider as appropriate. Table 2 of 7 CFR 246.10(e)(10) allows the CPA, as established by State agency policy, to determine the need for women to receive tofu in excess of the maximum substitution allowance. b. Technical Requirements for Medical Documentation Under the interim rule, technical requirements for medical documentation were established. A total of 51 comments opposed the provision requiring health care providers to prescribe the supplemental foods and quantities appropriate for a participant’s qualifying condition in Food Package III (for participants with qualifying PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 conditions). Commenters believe that medical documentation, especially for authorization of supplemental foods in Food Package III, is burdensome to State agencies, participants and the medical community. Commenters stated that this provision has little value since the foods could otherwise be purchased by the participants at grocery stores. Commenters also stated that the WIC nutritionist or registered dietitian is capable of determining appropriate amounts and types of supplemental foods to issue to participants based on a nutrition assessment of the participant. Due to the nature of the health conditions of participants who are issued supplemental foods in Food Package III, close medical supervision is essential for each participant’s dietary management. FNS considers it appropriate that the responsibility for this close medical supervision remain with the participant’s health care provider. Medical documentation requirements for specific supplemental foods that do not usually require a prescription were established to ensure that the participant’s healthcare professional has determined that the supplemental foods are not medically contraindicated by the participant’s condition. Therefore, FNS retains the technical requirements for medical documentation for supplemental foods in Food Package III as written in the interim rule. However, FNS recognizes that WIC registered dietitians and/or qualified nutritionists play an important role in the continuum of care of medically fragile WIC participants. Therefore, FNS would support State agency policy that allows health care providers to refer to the WIC registered dietitian and/or qualified nutritionist for identifying appropriate supplemental foods (excluding WIC formula) and their prescribed amounts, as well as the length of time the supplemental foods are required by the participant. This arrangement would be supported only in situations where the health care provider has indicated on the medical documentation form that the provider acknowledges referral to the WIC registered dietitian and/or qualified nutritionist for such determinations. This gives the health care provider medical oversight while allowing the WIC registered dietitian and/or qualified nutritionist to determine the appropriate issuance of WIC foods to participants with qualifying conditions in Food Package III. 4. Sodium Content of WIC Foods In its Report, the IOM found that intakes of sodium were excessive in the E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES2 diets of WIC participants. The IOM reported that more than 90 percent of WIC children 2 through 4 years and of pregnant, lactating, and nonbreastfeeding postpartum women had usual sodium intakes above the Tolerable Upper Intake Level (UL). More than 60 percent of WIC children age 1 year had usual sodium intakes above the UL. As such, the IOM recommended, and the interim rule reflected, reductions in the overall sodium level of WIC food packages. The majority of WIC foods under the interim rule may not contain added salt (sodium). However, options for some WIC foods, i.e., cheese, vegetable juice, canned vegetables, canned beans, peanut butter, and canned fish include both regular and lower sodium varieties. In an effort to support participants in reducing sodium intake, FNS provided technical assistance to State agencies encouraging them to offer only lower sodium varieties of these foods when these options exist. FNS encourages WIC State agencies that offer canned vegetables to allow only lower sodium canned vegetables and lower-sodium versions of other WIC-eligible foods, i.e., breads, as they become more widely available in the marketplace. FNS encourages food manufacturers to reduce excess sodium in processed foods and to make a wider variety of these foods available to help WIC achieve its goal to safeguard the health of children and women. 5. Organic Foods The interim rule authorizes organic forms of foods that meet minimum nutrition requirements described in Table 4 of 7 CFR 246.10(e)(12). However, WIC State agencies are responsible for determining the specific brands and types of foods to authorize on their State WIC food lists. Some State agencies allow organic foods on their foods lists, but this will vary by State. The decision may be influenced by a number of factors such as cost, product distribution within a State, and WIC participant acceptance. FNS received 52 comments asking that State agencies be required to offer organic foods in the WIC food packages. Many of these comments were from one State where the WIC State agency had recently removed organic milk from its list of authorized WIC foods. This final rule continues to provide State agencies the option to offer organic forms of WICeligible foods through the regular WIC food instrument, e.g., milk, eggs, peanut butter, and encourages State agencies to make available authorized foods that are acceptable and will be consumed by participants, including organic varieties. VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 This final rule clarifies in Table 4 of 7 CFR 246.10(e)(12) that State agencies are required to allow organic forms of fruits and vegetables purchased with the cashvalue voucher. C. Supplemental Foods and Food Packages Note: The order of some of the topics in this section is modified from the interim rule for the purposes of discussion. 1. Fruits and Vegetables in Food Packages III Through VII a. Dollar Amount of Cash-Value Voucher In order to maintain cost neutrality, the interim rule published December 2007 (72 FR 68966) only provided fully breastfeeding women with the IOM recommended amount of $10.00 per month fruit and vegetable cash-value vouchers; all other women participants were provided $8.00 per month, and children were provided $6.00. An amendment to the interim rule was published in the Federal Register on December 31, 2009 (74 FR 69243) to provide all WIC women participants with $10.00 per month fruit and vegetable cash-value vouchers, consistent with IOM’s recommendations. A total of 448 commenters (76 form letters) asked FNS to increase the fruit and vegetable cash-value voucher to the IOM recommended level from $6 to $8 for children. The Department has responded to commenters’ requests under this final rule by increasing the cash-value voucher for children to $8 per month. This increase will allow State agencies to further efforts to increase fruit and vegetable consumption by children. A total of 162 commenters (36 form letters) asked FNS to further increase the fruit and vegetable voucher for fully breastfeeding women from $10 to $12 to provide incentive for women to choose to fully breastfeed, and to meet the intent of the IOM to provide an enhancement to the food packages for fully breastfeeding women. While FNS understands the benefit of increasing the value of the food package for fully breastfeeding women, it is not possible under this rulemaking to go beyond the dollar value for the cash-value voucher for the fully breastfeeding package due to cost. Therefore, the cash-value voucher remains at $10 for all women, including fully breastfeeding women, in this final rule. The base year for calculation of the value of the fruit and vegetable voucher and the base value to be used are updated in 7 CFR 246.16(j)(2). PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 12277 b. Clarification of Authorized Fruits and Vegetables To improve the consumption of fresh fruits and vegetables and to appeal to participants of different cultural backgrounds, the interim rule authorized a wide variety of choices within the authorized fruit and vegetable options. The interim rule reflects the IOM recommendation to provide a cash-value fruit and vegetable benefit to participants with few restrictions. The following is a discussion of clarifications and revisions to the interim rule pertaining to authorized fruits and vegetables. Technical corrections in this final rule clarify that both fresh fruits and fresh vegetables must be authorized by State agencies. This final rule further clarifies that 21 CFR 101.95 defines the term ‘‘fresh’’ when referring to eligible fresh fruits and vegetables. Technical corrections in this final rule clarify that the cash-value voucher may be redeemed for any eligible fruit and vegetable (refer to Table 4 of 7 CFR 246.10(e)(12) and its footnotes). Except as authorized by this final rule, State agencies may not selectively choose which fruits and vegetables are available to participants. For example, if a State agency chooses to offer dried fruits, it must authorize all WIC-eligible dried fruits, i.e., those without added sugars, fats, oils, or sodium, and may not allow only a single variety of dried fruits. This final rule clarifies that State agencies may, however, invoke their administrative option at 7 CFR 246.10(b)(1)(i) to establish criteria in addition to the minimum Federal requirements in Table 4 of 7 CFR 246.10(e)(12), which could include restricting packaging (such as plastic containers) and package sizes (such as single serving) of processed fruits and vegetables available for purchase with the cash-value voucher. In addition, State agencies may identify specific types of certain processed WIC-eligible fruits and vegetables (e.g., salsas, tomato sauces, stewed and diced tomatoes) on their food lists if they believe there is cause for significant vendor and participant confusion in identifying specific items within those categories that are WIC-eligible. A technical correction has been made in Table 4 of 7 CFR 246.10(e)(12) to clarify that the following products are not allowed: Dried white potatoes, mixed vegetables containing white potatoes, noodles, nuts or sauce packets, and decorative flowers and blossoms. Canned tomato sauce and tomato paste without added sugar, fats, oils are authorized. Salsa and spaghetti sauce E:\FR\FM\04MRR2.SGM 04MRR2 12278 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations without added sugar, fats, and oils are also authorized. This final rule clarifies that the fruit or vegetable must be listed as the first ingredient in WIC-eligible processed fruits and vegetables. In addition, it clarifies that frozen fruits may not contain added fats, oils, salt (i.e., sodium) or added sugars. For the reasons described in section IV.B.4 of this preamble, Table 4 of 7 CFR 246.10(e)(12) will be revised to allow State agencies the option to offer only lower sodium canned vegetables for purchase with the cash-value voucher. mstockstill on DSK4VPTVN1PROD with RULES2 c. White Potatoes The interim rule excludes the purchase of white potatoes with the cash-value voucher. A total of 266 (of these, 213 were form letters) opposed the restriction of white potatoes. Commenters stated that white potatoes should be included in the WIC food packages because they are versatile, economical, contain key nutrients, and are preferred by participants. Thirty-two commenters (20 form letters) stated that the exclusion of white potatoes is difficult to administer. The restriction of white potatoes, as recommended by the IOM, is based on data indicating that consumption of starchy vegetables meets or exceeds recommended amounts, and food intake data showing that white potatoes are the most widely used vegetable. Including white potatoes in the WIC food packages would not contribute towards meeting the nutritional needs of the WIC population and would not support the goal of expanding the types and varieties of fruits and vegetables available to program participants, as recommended by the IOM. Therefore, the provision to exclude white potatoes from the WIC food packages is retained in this final rule. The Department recognizes that white potatoes can be a healthful part of one’s diet. However, WIC food packages are carefully designed to address the supplemental nutritional needs of a specific population. Although white potatoes are not offered in the WIC food package, nutrition education provided to WIC participants will continue to include white potatoes as a healthy source of nutrients and an important part of a healthful diet. d. Dried Fruit and Dried Vegetables for Children As recommended by the IOM, the interim rule disallows dried fruits and vegetables to be purchased with the cash-value voucher for children because of the risk of choking. FNS received a VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 small number of comments asking that dried fruits be allowed for children, citing a lack of evidence that they pose choking hazards for all children. Recommendations made by IOM for the Child and Adult Care Food Program allow dried fruits for children as long as they do not pose a choking hazard.2 Therefore, at the State agency’s option, this final rule authorizes dried fruits and dried vegetables to be purchased with the cash-value voucher for children. Nutrition education regarding choking hazards, developmental readiness, proper food preparation, and oral health care should be provided to caregivers of young children. e. Standards of Identity for Canned Fruits and Canned Vegetables Two technical corrections have been in made in Table 4 of 7 CFR 246.10(e)(12) related to the standards of identity for canned fruits and canned vegetables. This final rule corrects the specifications for WIC-eligible canned fruits to reflect that only those WICeligible canned fruits that have a standard of identity, as listed at 21 CFR Part 145, must conform to the FDA standard of identity. Similarly, this final rule corrects the specifications for WICeligible canned vegetables to reflect that only those WIC-eligible canned vegetables that have a standard of identity, as listed at 21 CFR Part 155, must conform to the FDA standard of identity. The provision that WIC-eligible canned vegetables contain no added sugars, fats, and oils remains unchanged. This final rule clarifies that home-canned and home-preserved fruits and vegetables are not authorized. f. Implementation of Fruit and Vegetable Options (1) Paying the difference with the cash-value voucher. The interim rule authorized State agencies the option to allow participants to pay the difference if the fruit and vegetable purchase exceeds the value of the cash-value voucher, a transaction known as ‘‘split tender.’’ A total of 116 commenters (59 form letters) asked FNS to require all State agencies to allow split tender transactions to ensure that participants are able to maximize use of their cashvalue voucher. Because it may be difficult for participants to accurately estimate the exact purchase price of the fruit and vegetable selections, particularly when fresh, canned, dried, 2 Institute of Medicine, National Academy of Sciences. ‘‘Child and Adult Care Food Program: Aligning Dietary Guidance for All,’’ 2010. Available at Internet site: https://www.fns.usda.gov/child-andadult-care-food-program-aligning-dietary-guidanceall. PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 or frozen items are combined in one purchase or when items are purchased in bulk, FNS agrees that all participants should be allowed to pay the difference when the purchase of allowable fruits and vegetables exceeds the value of the fruit/vegetable cash-value voucher. Therefore, this final rule adds a provision at 7 CFR 246.12(f)(4) to require State agencies to allow split tender transactions with the cash-value voucher. (2) Minimum vendor stocking requirements. A technical oversight in the interim rule has been corrected at 7 CFR 246.12(g)(3)(i) by clarifying that authorized vendors must stock at least two different fruits and two different vegetables. (3) Authorizing farmers’ markets. The interim rule gave State agencies the option to allow farmers at farmers’ markets to accept cash-value vouchers. FNS received 29 comments (mostly form letters) recommending that farmers’ market organizations, rather than the individual farmer, be authorized to accept cash-value vouchers, as is permitted under the WIC Farmers’ Market Nutrition Program (FMNP). Sixty-nine commenters (mostly form letters) additionally recommended that the WIC Program regulations be more closely aligned with the FMNP. Commenters stated that consistency between the two programs would make FMNP participation easier both for WIC participants and authorized farmers. Many of the comments suggested that State agencies be allowed to authorize farmers’ markets in addition to the current provision (7 CFR 246.12(v)) that allows State agencies the flexibility to authorize farmers at farmers’ markets or roadside stands. FNS finds merit in such a provision; this also would provide more consistency between WIC and FMNP. Seventy-eight comments went on to suggest that the authorization of farmers’ markets should be a Federal requirement, rather than a State agency option. FNS believes that State agencies are in the best position to determine what works for their individual benefit delivery systems, taking into consideration such factors as participant access, the availability of farmers, and the administrative burdens of monitoring and authorization. Therefore, the final rule amends 7 CFR 246.12 to allow WIC State agencies to authorize farmers or farmers’ markets to accept WIC cash-value vouchers, but such authorization will remain as a State agency option. As a result of the addition of farmers’ markets, conforming amendments have been E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations made in 7 CFR 246.2, 246.4, 246.18, and 246.23. A number of comments were received recommending that the Federal WIC regulations be modified to be consistent with the fruits and vegetables eligible for purchase under the FMNP. FNS makes every effort to ensure that both programs are aligned in most areas, to the extent possible. However, each program has different statutory objectives. Thus, FNS is convinced that it is critical for each program to maintain its separate identity. As stated previously, FNS found merit in allowing farmers’ markets to redeem WIC cashvalue vouchers, an example of aligning both programs. FNS finds no need to make any further operational changes in this area through this final rule. A technical amendment is added to 7 CFR 246.4(a)(14) to correct a cross-reference to 7 CFR 246.12 that addresses the State agency options regarding vendor sanctions. 2. Mature Legumes (Dry Beans, Peas and Lentils) and Peanut Butter a. Clarification of Allowable Mature Legumes Technical corrections have been made to the list of authorized mature legumes in Table 4 of 7 CFR 246.10(e)(12). Refried beans, without added sugars, fats, oils, vegetables or meat, have been added to the examples of allowable legumes in Table 4 of 7 CFR 246.10(e)(12). The specification in Table 4 also clarifies that mature legumes issued via the WIC food instrument may not contain added vegetables or fruits. mstockstill on DSK4VPTVN1PROD with RULES2 b. Issuance of Mature Legumes (Dry Beans and Peas) The interim rule includes mature dry beans, peas, or lentils in dry-packaged or canned forms as a WIC food category. Items in this food category are issued via the regular WIC food instrument. FNS provided technical assistance to State agencies on the interim rule clarifying that beans and peas that do not qualify under this category may be purchased only with the cash-value voucher. A total of 23 commenters (8 of which were form letters) asked FNS to allow all mature varieties and forms of dry beans and peas to be purchased with both the cash-value voucher and the WIC food instrument to eliminate confusion on the part of participants and vendors. The nutritional profile of mature dry legumes is different than that for immature varieties and FNS believes it is important to maintain this distinction. Mature legumes are excellent sources of plant protein, and VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 also provide other nutrients such as iron and zinc. Mature dry beans and peas are similar to meats, poultry, and fish in their contribution of these nutrients. In WIC, they are offered as a separate food category from the fruit and vegetable category. Therefore, mature legumes in dry-packaged and canned forms, without added vegetables, fruits, meat, sugars, fats, or oils, are the only dry beans and peas authorized to be issued via the WIC food instrument. c. Disallowed Ingredients in Peanut Butter A technical oversight has been corrected in Table 4 of 7 CFR 246.10(e)(12) to disallow peanut butter with added marshmallows, honey, jelly, chocolate/or similar ingredients. 3. Fruit and Vegetable Juice Technical corrections have been made in Table 4 of 7 CFR 246.10(e)(12) related to the standard of identities for canned fruit and vegetable juices. This final rule corrects the specifications for WICeligible canned fruit juice and vegetable juice to reflect that only those WICeligible juices that have a standard of identity, as listed at 21 CFR Part 146 and 21 CFR Part 156, must conform to these FDA standards of identity. 4. Milk and Milk Alternatives a. Whole milk for participants greater than 2 years of age. Under the interim rule, and as recommended by the IOM, whole milk is not authorized for children greater than 2 years of age and women in Food Packages IV–VII. Under the interim rule, whole milk may be issued to medically fragile children older than 2 years of age and women only in Food Package III for participants with qualifying conditions. A total of 216 commenters, primarily local agency WIC staff, asked FNS to allow the CPA to prescribe whole milk for participants in any food package if necessary for participants who have medical or nutritional reasons for requiring additional calories. FNS believes that WIC staff can assist participants in Food Packages IV–VII in meeting their nutritional needs through fat-reduced milks and other foods. Whole milk adds unnecessary saturated fat and cholesterol to the diets of participants. Nutrition education and individual tailoring of the food package within authorized parameters remain the most effective tools for WIC staff to use to help participants make appropriate choices based on their specific needs. Therefore, the provision to authorize whole milk for children greater than 2 years of age and women only in Food Package III is retained in PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 12279 this final rule in Table 3 of 7 CFR 246.10(e)(11). b. Fat-Reduced Milks for Children 12 Months to 2 Years of Age in Food Package III and IV Under the interim rule, children 12 months to 2 years of age may only be issued whole milk. A total of 332 commenters (34 form letters) want flexibility in this provision, citing American Academy of Pediatrics (AAP) policy,3 recommending fat-reduced milks for children over the age of 1 for whom overweight or obesity is a concern. In light of current AAP policy, FNS will allow, at State agency option, fatreduced milks to be issued to 1-year-old children (12 months to 2 years of age) for whom overweight or obesity is a concern. Under Food Package IV, FNS will allow the CPA to make a determination for the need for fatreduced milks for young children based on an individual nutritional assessment and consultation with the child’s health care provider if necessary, as established by State agency policy. FNS will provide technical assistance for issuing fat-reduced milks to children 12 months to 2 years of age in Food Package IV. Due to the medically fragile qualifying conditions of children 12 months to 2 years of age, FNS will continue to require medical documentation for issuance of WICeligible formula and foods, including fat-reduced milks, under Food Package III. c. Fat Content of Milk for Children Over 2 Years of Age and Women Under the interim rule, children ≥ 24 months of age and women may be issued a variety of milk types (i.e., nonfat, lowfat (1%) and reduced fat (2%) milk). Seven commenters recommended the issuance of only nonfat or lowfat (1%) milk to children ≥ 24 months of age and women to be consistent with the Dietary Guidelines for Americans. FNS notes that State agencies already have policies to ensure that CPAs issue the appropriate milk to participants based on the assessed nutritional needs of individual participants. Since 1995 the Dietary Guidelines for Americans have recommended consumption of nonfat and lowfat milk and milk products. In technical assistance provided to State agencies on the interim rule, FNS supported and encouraged State agencies to issue only nonfat and lowfat 3 American Academy of Pediatrics. Policy Statement Lipid Screening and Cardiovascular Health in Childhood, Pediatrics Vol. 122 No. 1 July 2008, pp. 198–208. E:\FR\FM\04MRR2.SGM 04MRR2 12280 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations authorized milk substitutes to fulfill the maximum allowance. Because milk in quart sizes has become more widely available as States have implemented the interim rule, and this final rule allows the option of providing a quart of yogurt for children and women (as described in a subsequent section of this preamble), and allows issuance of a 12 ounce can of evaporated milk to substitute for the ‘‘dangling quart,’’ State agency concerns about difficulty providing the full milk benefit to participants who substitute cheese for milk should be alleviated. State agencies also have the option to prescribe half gallon containers of milk every other month for participants in lieu of the ‘‘dangling quart.’’ d. Fortification of Whole Milk This final rule clarifies the minimum nutrient requirements for all milks listed in Table 4 of 7 CFR 246.10(e)(12). The table restates the milk specifications to make it clearer that vitamin A fortification is not required for whole milk. mstockstill on DSK4VPTVN1PROD with RULES2 milk to children and women unless otherwise indicated by nutrition assessment. As such, FNS finds merit in adding a provision that nonfat and lowfat (1%) milks are the standard issuance for children ≥ 24 months of age and women in Food Packages IV–VII. Reduced fat (2%) milk is authorized only for participants with certain conditions, including but not limited to, underweight and maternal weight loss during pregnancy. The need for reduced fat (2%) milk for children ≥ 24 months of age (Food Package IV) and women (Food Packages V, VI, VII) will be determined as part of the careful nutrition assessment completed by the CPA, as established by State agency policy. f. Cheese in Excess of Maximum Substitution Rates Under the interim rule, cheese may be substituted for milk. The IOM set a substitution rate for cheese for milk, but put a cap on the amount that can be substituted to control total and saturated fat content of the food packages. Under the interim rule, FNS allowed, with medical documentation, additional amounts of cheese to be issued beyond the substitution rate to provide State agencies with flexibility to accommodate participants with lactose intolerance. This accommodation was made because, at the time, milk alternatives for participants with lactose intolerance were more limited. Few soybased beverages that met FNS’ nutritional standards were available, and the interim rule did not authorize yogurt, which had been recommended by IOM as a milk substitute. Since that time, more soy-based beverages that meet the nutritional standards established by FNS are available in the marketplace, and this final rule authorizes yogurt for children and women. As a result, State agencies have increased flexibility, in addition to offering lower lactose milks, to accommodate lactose intolerance with substitutes other than cheese, as recommended by the IOM. Therefore, this final rule will no longer allow cheese to be issued beyond established substitution rates, even with medical documentation, which is consistent with the recommendation of the IOM. e. Provision of Maximum Monthly Allowance of Milk Under the interim rule, the maximum monthly allowance of milk must be provided to participants, as the WIC benefit to participants is the full authorized amount. The interim rule allows a substitution rate of 1 pound of cheese for 3 quarts of milk, leaving a quart of milk or milk substitute that must be provided to participants issued this option to fulfill the maximum allowance in the food package. A total of 17 commenters (6 of these form letters) asked FNS to drop the ‘‘dangling quart’’ or allow State agencies to round the quantity of milk up when substituting cheese for milk because of limited availability and higher costs of milk in quart size containers. A total of 20 commenters (6 of these form letters) asked FNS to allow State agencies to issue 12 ounce cans of evaporated milk, which are the largest size available in the marketplace and which reconstitute to 24 fluid ounces, as the ‘‘dangling quart.’’ The IOM cited milk as an important source of calcium and vitamin D for WIC participants, and this food category should not be shortchanged. Therefore, the ‘‘dangling quart’’ may not be ignored. This final rule will continue to require that State agencies provide the maximum allowance of milk to participants if cheese is substituted for milk in order for participants to obtain their full milk benefit. State agencies continue to have the option to make available other VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 g. Yogurt The IOM recommended adding yogurt to the WIC food packages as a partial milk substitute for children and women. However, under the interim rule, FNS determined that the addition of yogurt to the WIC food packages was cost prohibitive. The interim rule solicited comments from State agencies about the PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 extent to which WIC participants would benefit from the addition of yogurt, and whether that addition could be achieved in a cost-effective manner. A total of 304 comment letters (63 of these form letters) encouraged FNS to allow yogurt as a milk substitute, emphasizing that yogurt provides priority nutrients and is convenient, popular, and culturally acceptable to WIC participants. Commenters also cited a pilot study, conducted by the California WIC Program in conjunction with the National Dairy Council, which demonstrated the feasibility of providing yogurt in WIC food packages.4 The pilot study results cited participant acceptance and ease of implementation. FNS agrees that yogurt is a desirable milk alternative for participants who might not otherwise drink sufficient amounts of fluid milk due to lactose intolerance or other reasons. Therefore, this final rule authorizes yogurt as a substitute for milk for children and women in Food Packages III–VII, at the State agency’s option. (1) Maximum Monthly Allowance of Yogurt At State agency option, 1 quart of yogurt may be substituted for 1 quart of milk for women and children in Food Packages III–VII. No more than 1 quart of yogurt is authorized per participant. (2) Authorized Yogurts As recommended by the IOM, yogurt must conform to the standard of identity for yogurt as listed in Table 4 of 7 CFR 246.10(e)(12) and may be plain or flavored with ≤ 40 grams of total sugar per 1 cup of yogurt. Only lowfat and nonfat yogurts are authorized for children over 2 years of age and women. Whole fat yogurt is authorized only for children less than two years of age. State agencies have the option to determine the container sizes of yogurt to authorize on their food lists. h. Tofu Under the interim rule, calcium-set tofu prepared only with calcium salts, (e.g., calcium sulfate), and without added fats, sugars, oils, or sodium, is authorized. A technical correction has been made in this final rule to clarify that tofu must be calcium-set, i.e., contain calcium salts, but may also contain other coagulants, i.e., magnesium chloride. This additional flexibility allows State agencies to meet the needs of WIC’s culturally diverse participants. Tofu with only calcium 4 Fung, EB, et al. Randomized, controlled trial to examine the impact of providing yogurt to women enrolled in WIC. J Nutr Educ Behav. 2010 May– Jun;42(3 Suppl):S22–9. E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations sulfate may not be readily available in the marketplace. Major tofu manufactures with national distribution make tofu with calcium sulfate alone or in addition to magnesium chloride as a coagulant. Magnesium chloride is not a flavoring or preservative, and should not be confused with sodium chloride, which is not permitted. The calcium content of various types of tofu, even those set only with calcium salts, varies. In choosing the brands and types of calcium-set tofu to include on food lists, State agencies should read the nutrition labels and choose tofu with the highest amount of calcium. 5. Breastfeeding Provisions Under the interim rule, food packages for infants and women are designed to strengthen WIC’s breastfeeding promotion and support efforts and provide additional incentives to assist mothers in making the decisions to initiate and continue to breastfeed. The provisions disallow routine issuance of infant formula to partially breastfeeding infants in the first month after birth to help mothers establish milk production and the breastfeeding relationship. Overall, commenters expressed support for the breastfeeding provisions, with 7 State agencies stating they have already seen increases in breastfeeding rates attributable to the interim rule provisions. State agencies stressed that adequate training of WIC staff and the provision of appropriate counseling and support to mothers is critical to the success of the new food packages for the breastfeeding mothers and their infants. mstockstill on DSK4VPTVN1PROD with RULES2 a. Exclusive Breastfeeding This final rule clarifies the intent of the WIC Program that all women be supported to exclusively breastfeed their infants and to choose the fully breastfeeding food package without infant formula at 7 CFR 246.10(e). Breastfeeding women who do not exclusively breastfeed are to be supported to continue breastfeeding to the maximum extent possible through minimum supplementation with infant formula. b. Clarification of Partially Breastfeeding Terminology Commenters asked FNS to address terminology used to describe the mother-infant pair who ‘‘partially’’ breastfeed (both breastfeed and formula feed). Confusion exists because partially breastfeeding is used to describe a combination of any amounts of breastfeeding and formula feeding. However, under the interim rule, for the purposes of food package issuance, the partially breastfeeding food package is VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 defined by a maximum quantity of formula that assumes the mother is substantially breastfeeding her infant. Confusion also exists because WIC’s definition of a breastfeeding woman is the practice of feeding a mother’s breast milk to her infant on the average of at least once a day. This definition determines the categorical eligibility of a participant as a breastfeeding woman, and did not change under the interim rule revising the WIC food packages. All women who meet this definition are counted as breastfeeding women for participation purposes, regardless of the food package they are issued or the amount of formula their infants receive. Under the interim rule, three infant feeding variations are defined for the purposes of assigning food quantities and types in Food Packages I and II for infants: (1) Fully formula feeding, (2) fully breastfeeding (the infant does not receive formula from the WIC Program), and (3) partially breastfeeding (the infant is breastfed but also receives some infant formula from WIC up to the maximum allowance described for partially breastfed infants in Table 1 of 7 CFR 246.10(e)(9)). Breastfeeding assessment and the mother’s plans for breastfeeding serve as the basis for determining food package issuance. Breastfed infants who are assessed to need more formula than is allowed under the food package for partially breastfed infants are assigned to the fully formula feeding package. FNS agrees that terminology used to describe food packages for the motherinfant pair that both breastfeed and formula feed, regardless of amount from either source, needs clarification. Therefore, this final rule attempts to minimize confusion about food package issuance by parenthetically adding the descriptor ‘‘mostly’’ breastfeeding to the partially breastfeeding food package designation established under the interim rule. c. Issuance of Formula to Breastfed Infants There has been some confusion about the issuance of one can of powder infant formula in the first month to breastfed infants. For breastfeeding women who do not receive the fully breastfeeding package, WIC staff are expected to individually tailor the amount of infant formula based on the assessed needs of the breastfeeding infant and provide the minimal amount of formula that meets but does not exceed the infant’s nutritional needs. This is consistent with long-standing FNS policy that dates back to the 1980s. State agencies should develop policies for handling breastfeeding mothers’ formula requests PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 12281 that encourage substantial and continued breastfeeding. This is true whether the infant receives the fully formula feeding package (although the infant may be minimally breastfeeding) or the partially (mostly) breastfeeding food package. The full nutrition benefit should not be used as the standard for issuance unless the mother is not breastfeeding the infant at all. The interim rule strengthened the WIC food packages to better enhance breastfeeding promotion and support. Food packages for partially (mostly) breastfed infants and women were created that provide additional foods for mothers as incentives, to better meet nutritional needs, and to provide less infant formula to partially breastfed infants than to infants who receive the fully formula fed package. The food packages for partially (mostly) breastfed mothers and infants are designed to provide for the supplemental nutrition needs of the breastfeeding pair, provide minimal formula supplementation to help mothers maintain milk production, and provide incentives for continued breastfeeding by way of a larger variety and quantity of food than the full formula/postpartum packages. FNS emphasizes that the benefits of the partially breastfed food packages are lost if the breastfeeding mother-infant pair is issued the full formula/postpartum packages. Appropriate support and counseling should be provided to mothers to minimize the number of breastfeeding infants receiving the full formula packages. This final rule clarifies at 7 CFR 246.10(b)(2)(ii)(C) that food package quantities are to be issued based on assessment of each participant’s individual breastfeeding and nutritional needs. d. Issuance of Formula to Breastfed Infants in the First Month After Birth This final rule clarifies that the issuance of any formula to breastfed infants in the first month after birth is a State agency option. If a State agency chooses this option, it may issue one can of powder infant formula in the container size that provides closest to 104 reconstituted fluid ounces to partially breastfed infants on a case-bycase basis. Breastfed infants who are provided this option are considered partially (mostly) breastfed. Breastfed infants should not receive more than the one can option in order to maintain the mother’s milk production. State agencies should not create food packages that standardize issuance of formula to partially (mostly) breastfed infants in the first month after birth. E:\FR\FM\04MRR2.SGM 04MRR2 12282 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES2 e. Food Package VII for Fully Breastfeeding Women Under the interim rule, Food Package VII is issued to three categories of WIC participants—fully breastfeeding women whose infants do not receive formula from the WIC Program; women pregnant with two or more fetuses, and women fully or partially (mostly) breastfeeding multiple infants. This final rule clarifies that Food Package VII is issued to partially (mostly) breastfeeding mothers who are breastfeeding multiples from the same pregnancy. A total of 12 commenters (4 form letters) asked that partially breastfeeding women who are also pregnant be allowed to receive the more enhanced Food Package VII. FNS agrees with commenters that pregnant women who are also partially (mostly) breastfeeding singleton infants would benefit from the increased quantity and variety of foods in this food package. Therefore, this final rule authorizes pregnant women who are also partially (mostly) breastfeeding to receive Food Package VII. Under the interim rule, women fully breastfeeding multiples receive 1.5 times the maximum allowance of foods authorized in Food Package VII to meet their nutritional needs. A total of 36 commenters (8 form letters) asked FNS to revise the food package quantities for women fully breastfeeding multiples to reflect a consistent amount each month and to specify amounts in quantities available in marketplace. In technical assistance provided to State agencies on the interim rule, FNS provided flexibility to allow States to choose how they will issue these quantities. Some States have elected to issue foods in this food package in amounts averaged over a 2-month timeframe to eliminate concern about providing quantities available in the marketplace. Others issue double the ‘‘regular’’ fully breastfeeding package one month and then issue the ‘‘regular’’ fully breastfeeding package the next month. FNS will allow State agencies to retain the flexibility to determine how best to issue food packages quantities for women fully breastfeeding multiples and therefore will not change the provision to specify a set amount that must be provided each month. f. Human Milk Fortifier (HMF) Fifteen commenters (4 form letters) asked that partially (mostly) breastfeeding women whose infants receive human milk fortifier (HMF) be considered fully breastfeeding. VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 Issuance of HMF as a WIC formula is allowed with medical documentation under the interim rule, as it was under previous WIC policy. A woman whose infant receives HMF is considered partially breastfeeding because her infant is receiving formula from WIC. HMF provides additional protein, minerals, and vitamins that, when added to breastmilk in the first postpartum month for premature infants, results in nutrient, mineral, and vitamin concentrations similar to those of the formulas developed for feeding preterm infants. HMF is given in the hospital, but most often is discontinued prior to discharge. There is a limit on how long HMF is necessary and the need and length of time an infant should remain on HMF should be determined and monitored by the health care provider. Since HMF is to be used for only a very short time, the woman can be transitioned back to the fully breastfeeding package as soon as the infant is no longer receiving HMF from WIC. The final rule will retain the provision that Food Package VII is issued only to women whose infants do not receive formula from WIC, including HMF. 6. Whole Wheat Bread and Whole Grain Options a. Authorized Breads Under the interim rule, whole wheat breads, rolls and buns that meet the FDA standard of identity for whole wheat bread (21 CFR 136.180) are authorized. Some commenters asked FNS to allow baked products that do not meet the standard of identity for whole wheat bread, e.g., English muffins and bagels, if these products otherwise meet the whole wheat requirements. FNS has considered this request, but has determined that identifying the WICeligibility of whole wheat bread products that do not meet the standard of identity would be complex given the number of products in the marketplace. Therefore, the requirement that whole wheat breads meet the standard of identity for whole wheat bread is retained in this final rule in Table 4 of 7 CFR 246.10(e)(12). b. Package Sizes of Whole Wheat/Whole Grain Bread The interim rule established a maximum monthly allowance of two pounds of whole wheat bread or other whole grain options for children in Food Packages III and IV; and one pound of whole wheat bread or other whole grain options for women in Food Packages III, V and VII. Commenters PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 asked that FNS authorize bread in the more commonly available 20 ounce package size. Although the availability of bread in package sizes to meet the WIC maximum monthly amount of bread authorized in WIC food packages was of initial concern as State agencies planned to implement the new food packages and supply in the marketplace may have been limited, bread manufacturers have increasingly produced WIC-eligible breads in 16 ounce package sizes to respond to the changes in the WIC Program. As such, all State agencies have breads in appropriate size packages on their WIC food lists. A greater number of WICeligible breads in 16 ounce package sizes continue to be introduced by manufacturers, which will further increase the bread options available to participants. Therefore, FNS believes that this situation has been addressed and the maximum allowance for whole wheat and whole grain bread is unchanged in this final rule. c. Expansion of Whole Grain Options Under the interim rule, whole grains (brown rice, bulgur, oats, and whole grain barley), as well as tortillas, are authorized as substitutions for whole wheat and whole grain bread. A total of 310 commenters (22 of these form letters) asked FNS to consider expanding the list of whole grain foods available to participants. Suggestions included whole grain pasta, whole wheat English Muffins, and whole wheat bagels. To make available additional whole grain foods to participants, this final rule will add whole wheat pasta to the list of whole wheat/whole grain bread alternatives. Whole wheat macaroni (pasta) products that meet the FDA standard of identity (21 CFR 139.138) and have no added sugars, fats, oils, or salt (i.e., sodium) are WIC-eligible. Other shapes and sizes that otherwise meet the FDA standard of identity for whole wheat macaroni (pasta) products are also authorized (e.g. whole wheat rotini, whole wheat penne). d. Technical Corrections In technical assistance provided to State agencies on the interim rule, FNS clarified that State agencies must offer whole wheat and/or whole grain bread. State agencies have the option to also authorize the other whole grain options listed in Table 4 of 7 CFR 246.10(e)(12). This final rule clarifies this provision. Also, consistent with technical assistance provided to State agencies on the interim rule, FNS clarifies in Table 4 of 7 CFR 246.10(e)(12) of this final E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES2 rule that corn tortillas made from ground masa flour (corn flour) using traditional processing methods are WICeligible. FNS recognizes that a small loss of corn kernel occurs during the traditional processing of tortillas, and therefore, such tortillas are not considered whole grain. FNS encourages State agencies to authorize corn tortillas that have whole corn listed as their primary ingredient. However, if the market availability of such corn tortillas is limited, FNS will allow State agencies to authorize corn tortillas made from ground masa flour using traditional processing methods, due to the high participant acceptance of corn tortillas, especially among Hispanic cultures. A technical clarification has been made in Table 4 of 7 CFR 246.10(e)(12) to the minimum requirements and specifications for whole wheat tortillas to address the types of flour authorized. This final rule continues to require that whole grain breads and cereals meet FDA labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat content.’’ However, for simplicity and clarity, the final rule removes the specifics of the labeling requirements from Table 4 of 7 CFR 246.10(e)(12) and instead refers readers and manufacturers directly to the FDA health claim notification for further reference at https://www.fda.gov/food/ ingredientspackaginglabeling/ labelingnutrition/ucm073634.htm. A technical clarification has been made in Table 4 of 7 CFR 246.10(e)(12) to the minimum requirements and specification for whole wheat bread to address consistency with the standard of identity for whole wheat bread. For additional clarity and to aid State agencies and participants in identifying WIC-eligible whole grain bread products, a statement has been added to the requirements noting whole grain breads must conform to the FDA standard of identity for bread, buns and rolls. 7. Breakfast Cereals Under the interim rule, at least one half of all breakfast cereals on each State agency’s authorized food list must meet the whole grain requirements as specified in Table 4 at 7 CFR 246.10(e)(12). This provision allows certain corn and rice-based cereals to be offered to participants who may have allergies to whole grain cereals. FNS is retaining this provision in this final rule, but encourages State agencies to issue whole grain cereals to participants to the maximum extent possible, reserving non-whole grain options for those participants with allergies or other VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 medical reasons where whole grains are contraindicated. Participants should receive nutrition education on the benefits of whole grain in the diets to reduce the risk of coronary heart disease and type-2 diabetes, help with body weight maintenance, and increase intake of dietary fiber. A technical correction has been made in this final rule in Table 4 of 7 CFR 246.10(e)(12) to clarify that there is no FDA standard of identity listed for breakfast cereals. 8. Infant Foods in Food Packages II and III a. Fresh Bananas as Substitute for Jarred Infant Foods Under the interim rule, State agencies have the option to offer fresh bananas as a substitute for up to 16 ounces of infant food fruit at a rate of one pound of bananas per eight ounces of infant food fruit via the regular WIC food instrument. To ensure participants receive the full food package benefit of this provision, and to simplify the transaction for vendors as well as participants, FNS will also allow State agencies the option to substitute fresh bananas at a rate of one banana per four ounces of jarred infant food fruit, up to a maximum of 16 ounces, in Food Packages II and III for infants 6 to 12 months of age. This is consistent with recommendations of the IOM. b. Cash-Value Voucher in Lieu of Commercial Jarred Infant Foods Under the interim rule, jarred infant foods (fruits, vegetables, and meat) are provided in Food Packages II and III for infants 6 months through 11 months of age. Although this provision overall has been well received, concerns initially made by commenters on the proposed rule persist regarding this provision. A total of 508 commenters on the interim rule asked FNS to include a State option to provide a cash-value voucher to older infants receiving Food Packages II and III in lieu of commercial jarred infant food fruits and vegetables. Commenters stated that foods for older infants should be developmentally appropriate as infants transition to toddler foods, and noted the lack of availability of jarred infant foods in appropriate textures for the older infant. Commenters also stated that the amount of jarred infant foods in the WIC food packages is excessive for some older infants who are progressing in their feeding skills and transitioning from infant foods to table foods consumed during family meals. FNS remains committed to IOM’s recommendation that commercial jarred infant foods be provided in the WIC PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 12283 food packages to ensure that infants receive and consume fruits and vegetables in developmentally appropriate textures and in a variety of flavors. The IOM also intended that commercial jarred infant foods be provided to ensure that these items are consumed by infants and not other participants or family members. Food safety and nutrient content were also considerations. FNS recognizes these considerations and continues to provide commercial jarred infant foods in this final rule. FNS acknowledges the preference for alternative options for infants and agrees that the lack of developmentally appropriate infant foods available in the marketplace may make it difficult for State agencies to provide a range of textures appropriate for infants at different stages of development. This void in the market is particularly noted among infant food products for older infants, and may compromise the appropriate progression of an infant’s feeding skills. The FNS Infant Nutrition and Feeding Guide 5 indicates that at around nine months of age, most infants are developmentally ready to consume foods of increased texture and consistency. Such consistency should progress from pureed to ground to forkmashed and eventually to diced. Therefore, in light of these considerations, under this final rule, FNS will allow infants 9 months through 11 months of age to receive a cash-value voucher for the purchase of fresh fruits and vegetables in lieu of a portion of the infant food fruits and vegetables provided in Food Packages II and III. For partially breastfed infants and fully formula fed infants, participants may opt to receive a $4 cash-value voucher plus 64 ounces of infant food fruits and vegetables; fully breastfed infants may receive an $8 cash-value voucher plus 128 ounces of infant food fruit and vegetables. The decision to issue cash-value vouchers in lieu of infant food fruits and vegetables is a State agency option. If a State agency chooses this option, it may not categorically issue cash-value vouchers to all infants of this age group. Instead, the cash-value voucher is to be provided to the participant only after a thorough assessment by the CPA, as established by State agency policy, and is optional for the participant, i.e., the mother may choose to receive either the maximum allowance of jarred foods or the combination of jarred foods and a fruit 5 Food and Nutrition Service 2009. Infant Nutrition and Feeding: A Guide for Use in the WIC and CSF Programs. Available at Internet site: https://www.nal.usda.gov/wicworks/Topics/FG/ CompleteIFG.pdf. E:\FR\FM\04MRR2.SGM 04MRR2 12284 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations and vegetable cash-value voucher for her infant. State agencies must ensure that appropriate nutrition education is provided to the caregiver addressing safe food preparation, storage techniques, and feeding practices to make certain participants are meeting their nutritional needs in a safe and effective manner. States continue to have the option to offer, via the regular WIC food instrument, fresh bananas as a substitute for infant food fruit in Food Packages II and III for infants six to twelve months of age as described in section IV.C.8.a of this preamble. This final rule clarifies that a fruit or vegetable must be listed as the primary (first) ingredient in WIC-eligible jarred infant foods. Further, this final rule clarifies that combinations of single ingredients of fruits and/or vegetables (e.g., peas and carrots, apples and squash) are allowed in Food Package II and III for infants 6 to 12 months of age. c. White Potatoes in Jarred Infant Foods White potatoes are excluded from purchase with the cash-value voucher in the WIC food packages. However, this final rule clarifies that jarred infant foods that meet the minimum requirements and specifications for an infant food product and include white potatoes as an ingredient, but not the primary ingredient, are allowed in Food Packages II and III for infants 6 to 12 months of age. mstockstill on DSK4VPTVN1PROD with RULES2 d. Infant Cereal Under the interim rule, infant cereal is provided in Food Packages II and III for infants 6 months to 12 months of age. A total of 223 commenters (16 form letters) asked FNS to allow State agencies the option to offer ‘‘adult’’ breakfast cereals, as appropriate, to older infants to encourage developmental feeding skills and support the transition from infant foods to appropriate table and finger foods. Commenters stated that participants report not purchasing infant cereal because older infants prefer cereals they can eat with their fingers. The IOM recommended the provision of iron-fortified infant cereal for infants 6 to 12 months of age as a quality source of iron and zinc, nutrients needed by infants for optimal growth and development. Providing infant cereal for infants 6 months through 11 months of age is consistent with pediatric nutrition guidelines. The FNS Infant Nutrition and Feeding Guide 6 states that ready-to6 Food and Nutrition Service 2009. Infant Nutrition and Feeding: A Guide for Use in the WIC and CSF Programs. Available at Internet site: VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 eat, iron-fortified cereals designed for adults or older children are not recommended for infants because they: (1) often contain mixed grains; (2) tend to contain more sodium and sugar than infant cereals; and (3) typically contain less iron per infant-sized serving. Food safety is also of concern with the provision of adult cereals to infants as these products could cause choking if the infant is not developmentally ready to consume foods of this texture. For these reasons, the provision of ironfortified infant cereal for infants 6 months of age through 12 months of age in Food Packages II and III remains unchanged in this final rule. 9. Canned Fish The IOM recommended that a variety of canned fish that do not pose a mercury hazard be offered in Food Package VII. In addition to canned light tuna, canned salmon, and canned sardines, the interim rule authorized canned mackerel in Food Package VII for fully breastfeeding women. However, the two species of mackerel specified in the interim rule—N. Atlantic and Chub (Pacific)—are not readily available in canned form in the United States. FNS received 21 comments asking that canned Jack mackerel also be authorized in Food Package VII, citing its lower levels of mercury and acceptance by WIC participants. To allow more variety and choice among canned fish options, this final rule authorizes Jack mackerel as a canned fish option in Food Package VII. King mackerel is not authorized in any form. FNS encourages State agencies to offer all authorized canned fish options, i.e., tuna, salmon, sardines, and Jack mackerel, to ensure variety and choice for participants. This final rule also clarifies that canned fish with added sauces and flavorings, e.g., tomato sauce, mustard, lemon, are authorized at the State agency’s option. 10. Food Package III for Children and Women With Qualifying Conditions a. Infant Foods In Lieu of the CashValue Voucher Under the interim rule, children and women with qualifying conditions who require the use of a WIC formula (i.e., infant formula, exempt infant formula or WIC-eligible nutritional (formerly WICeligible medical food)) receive Food Package III. Among the supplemental foods provided to participants in this food package is a cash-value voucher to purchase fruits and vegetables. A total https://www.nal.usda.gov/wicworks/Topics/FG/ CompleteIFG.pdf PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 of 33 commenters requested the substitution of commercial jarred infant food fruit and vegetables in lieu of the cash-value voucher for participants over the age of one who have a qualifying medical condition, such as prematurity, developmental delays, and dysphasia (swallowing disorders). Commenters pointed out that these individuals would benefit from the use of this ready-to-feed form of pureed fruits and vegetables over the purchase of fresh fruits and vegetables. Food Package III is reserved for medically fragile participants who have specific dietary needs that are dictated by their medical condition. FNS is committed to providing these individuals with WIC Formula (i.e., infant formula, exempt infant formula and WIC-eligible nutritionals) and supplemental foods that best meet their special dietary needs. Thus, FNS finds merit in the argument that some participants with certain qualifying conditions may require a pureed form of fruits and vegetables to meet their nutritional needs, and would benefit from the convenience of purchasing jarred infant food fruits and vegetables. As such, this final rule allows State agencies the flexibility to provide children and women in Food Package III the option of receiving commercial jarred infant food fruits and vegetables in lieu of the cash-value voucher. The quantity of commercial jarred infant food fruits and vegetables is based on the substitution ratio of 128 ounces of infant food fruits and vegetables for the $8 cash-value voucher for children and 160 ounces of infant food fruits and vegetables for the $10 cash-value voucher for women. The need for commercial jarred infant food fruits and vegetables in lieu of the cash-value voucher will be determined by medical documentation that meets the criteria established in 7 CFR 246.10(d). Some participants may prefer to purchase fruits and vegetables via the cash-value voucher and process/puree the fruits and vegetables themselves; this remains an option and is encouraged for those who would benefit from this method of modifying the consistency and texture of foods to improve nutritional intake. Some commenters asked FNS to allow children in Food Package IV the option to receive commercial jarred infant foods in lieu of the cash-value voucher. However, FNS believes it appropriate that caregivers of children who do not have qualifying conditions making them eligible for Food Package III, and who need modifications in food consistency, receive nutrition education on choosing and preparing foods that meet the child’s needs, e.g., pureeing fruits and E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES2 vegetables and/or choosing those with soft texture/consistency. b. Allowance of Infant Formula in Food Package III for Infants Food package III is reserved for participants who have one or more qualifying conditions that require an exempt infant formula or WIC-eligible nutritional (formerly WIC-eligible medical food) to supplement their nutrition needs, as determined by the participant’s health care professional. Infants who have a qualifying condition and are successfully managed with an infant formula are issued Food Package I or II, as deemed appropriate for their age and feeding method. Under the interim rule, infants who require a combination of infant formula and a WIC-eligible nutritional or exempt infant formula are not able to receive both products through a WIC food package. In addition, these infants at 6 months of age may not be developmentally ready to consume solid foods due to their medical condition and would benefit from an increased amount of formula in place of infant foods at that timeframe. FNS received 74 comments requesting that infants who are not developmentally ready to consume solid foods be allowed increased infant formula amounts in lieu of infant foods in Food Package II. FNS agrees that there are a small percentage of infants who have a qualifying condition, such as prematurity, whose nutritional needs may be successfully managed with infant formula alone or a combination of infant formula and WIC-eligible nutritionals. These infants are considered medically fragile and would benefit from the close medical supervision provided under Food Package III. These infants may not be ready to consume infant foods at 6 months of age, as would otherwise generally healthy term infants, and they may benefit from receiving additional formula in lieu of infant foods at that time. Therefore, this final rule expands the type of formula authorized to infants with qualifying conditions in Food Package III to include infant formula. The issuance of infant formula in Food Package III would be strictly reserved for those infants who are medically fragile. Infants who do not have a qualifying condition and are otherwise generally healthy infants will continue to receive Food Packages I and II, as appropriate. In Food Package III, infants greater than 6 months of age may receive additional infant formula, exempt infant formula or WIC-eligible nutritionals (formerly WIC-eligible medical food) in lieu of infant foods at VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 the same maximum monthly allowance as infants ages 4 through 5 months of age of the same feeding option. As with exempt infant formula and WIC-eligible nutritionals, infants receiving infant formula in Food Package III will need medical documentation that meets the criteria established in 7 CFR 246.10(d). 11. Liquid Concentrate Infant Formula Amounts and Full Nutrition Benefit Table 1 in 7 CFR 246.10(e)(9) of the interim rule established the full nutrition benefit and the maximum monthly allowances of each physical form of infant formula, for each food package category and infant feeding variation. The interim rule also described the full nutrition benefit as the reconstituted fluid ounce amounts for liquid concentrate infant formula (based on a 13 ounce can) which formed the basis of substitution rates for other physical forms of infant formula (i.e., powder and ready-to-feed infant formula). Providing the full nutrition benefit amounts ensure that participants receive a comparable nutritional benefit no matter which physical form of infant formula they receive. For decades, infant formula manufacturers consistently provided liquid concentrate and ready-to-feed infant formula in container sizes or packaging that evenly divide into the maximum monthly allowance, while powder infant formulas traditionally vary in package size across manufacturers. FNS has become aware of a shift in the marketplace, such that liquid concentrate and ready-to-feed infant formula container sizes (i.e., 13 and 32-fluid ounces) are no longer standard for all major infant formula manufacturers. Because the maximum monthly allowance amounts of liquid infant formula under the interim rule are evenly divisible by a 13 ounce standard for liquid concentrate (reconstituted) and a 32 ounce standard of ready-to-feed infant formula, there is little flexibility to accommodate changes in the package size while still providing the full nutrition benefit and not exceeding the maximum monthly allowance amount. This final rule provides the technical correction of revised maximum monthly allowance amounts for liquid concentrate and ready-to-feed infant formula. The revision of maximum monthly allowance amounts for liquid infant formula (i.e., liquid concentrate and ready-to-feed) is consistent with the legislative authority granted to the Secretary of Agriculture in Section 733 of Public Law 111–80 and reiterated in Section 712 of Public Law 112–55, the Consolidated and Further Continuing PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 12285 Appropriations Act, 2012 that authorizes State Agencies to exceed the current maximum amount of liquid infant formula to ensure the full nutrition benefit be provided to participants. This will maintain competition in the infant formula market and address recent changes in package size availability of liquid concentrate and ready-to-feed infant formula. Liquid concentrate infant formula will now have a separate maximum monthly allowance amount different from the full nutrition benefit to accommodate market changes in packaging. This provision does not change the full nutrition benefit amounts as established in the interim rule. The full nutrition benefit will now be defined as the minimum amount of reconstituted liquid concentrate infant formula as specified in Table 1 of 7 CFR 246.10(e)(9) of this rule for each food package category and infant feeding option (e.g., Food Package IA fully formula fed, IA–FF). Infant formula issuance, whether using monthly issuance or rounding methodology, should be based on providing the amount of infant formula that most closely provides the full nutrition benefit to all infant participants as deemed appropriate based on breastfeeding assessment and infant food package and feeding method. At a minimum, State agencies must provide the full nutrition benefit to all non-breastfed infants. For breastfed infants, even those receiving the fully formula fed package, infant formula amounts should be tailored based on the assessed needs of the breastfed infant and provide the minimal amounts of formula that meets but does not exceed the infant’s nutritional needs. This final rule adds the definition of full nutrition benefit at 7 CFR 246.2. 12. Infant Formula Requirements Technical Correction A technical correction has been made to infant formula requirements in 7 CFR 246. 246.10(e)(1)(iii) to clarify the qualifying conditions for the types of supplemental foods (i.e., noncontract brand infant formula and any contract brand infant formula that does not meet the requirements in Table 4 of 7 CFR 246.10(e)(12)) that may be issued in this food package only with medical documentation. E:\FR\FM\04MRR2.SGM 04MRR2 12286 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations Procedural Matters Executive Order 12866 and Executive Order 13563 Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated a ‘‘significant regulatory action,’’ under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget. Regulatory Impact Analysis Summary As required for all rules that have been designated as Significant by the Office of Management and Budget, a Regulatory Impact Analysis (RIA) was developed for this final rule. The RIA for this rule was published as part of docket number FNS–2006–0037 on www.regulations.gov. A summary of the analysis follows: Need for Action. This final rule considers public comments submitted in response to the interim rule revising the WIC food packages published in December 2007 (72 FR 68966). The interim rule implemented the first comprehensive revisions to the WIC food packages since 1980. The interim rule revised regulations governing the WIC food packages to align them more closely with updated nutrition science and the infant feeding practice guidelines of the American Academy of Pediatrics, promote and support more effectively the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. This final rule addresses public comments received on the interim rule and makes adjustments that improve clarity of the provisions set forth in the interim rule. Benefits. The revised food packages were developed to better reflect current nutrition science and dietary recommendations, promote and support more effectively the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food than do current food packages, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural Estimate food preferences. The final rule makes additional administrative and food package changes that will allow local WIC agencies to better meet the nutritional needs and dietary preferences of program participants. Costs. FNS estimates that the cost of all mandatory and optional provisions in this final rule will total $1.17 billion over 5 years assuming State implementation beginning May 1, 2014 (for all provisions except the split tender and soy-based beverage for children provisions, which have effective dates of October 1, 2014) and yogurt for women and children with an effective date of April 1, 2015. If the optional provisions are adopted by fewer than all State agencies, then the cost of the rule will be lower. The cost of the mandatory provisions across all State agencies, plus the cost of the optional provisions by State agencies that serve half of WIC participants, is estimated to be $999 million over 5 years. Accounting statement. The following accounting statement gives the estimated discounted, annualized costs of the rule assuming full State agency implementation of the rule’s mandatory and optional provisions. The figures are computed from the nominal 5-year estimates developed in the full RIA. The accounting statement contains figures computed with 7 percent and 3 percent discount rates. Discount rate (percent) Year dollar Period covered Benefits Qualitative: The final rule modifies several provisions of the interim rule based on comments from State and local agencies, interest groups, participants, and others. These modifications better fulfill the intent of the interim rule and the IOM recommendations that are the basis for the WIC food package changes. The rule would increase the quantity of fruits and vegetables contained in the food packages for children to the level recommended by the IOM. The rule also gives States and local agencies more flexibility to meet the medical needs and cultural preferences of WIC participants. Recent research on WIC participants indicates that changes in the WIC food package have resulted in increases in consumption of healthful foods recommended by IOM (see RIA text). The effect of the rule, therefore is a benefit to participants and not simply a transfer of Federal funds replacing costs that WIC participants would have incurred in the absence of this rule. Because we do not quantify the value of the benefits in the impact analysis, and therefore cannot separate them from the estimated Federal transfer to WIC participants, we show our entire dollar impact under transfers. No longer requiring medical documentation for children to receive soy-based beverage and tofu as milk substitutes will save participants some time, although we believe the overall impact on that their time will be minimal and the savings will be nominal. There may also be a benefit in that some WIC participants may not have been taking the soy-based beverage and tofu substitution because getting medical documentation was presenting a barrier. Providing a mechanism to access soy-based beverage and tofu by working with a WIC Competent Professional Authority will help to remove that barrier and may result in nutrition benefits for this group of participants. Transfers $225.2 2014 7 ($millions/year) ........................................................................................... mstockstill on DSK4VPTVN1PROD with RULES2 Annualized Monetized ................................................................................ 230.5 2014 FY2014–2018 3 Quantified: The rule contains a mix of mandatory provisions and State options. For purposes of this impact analysis we estimate the value of both the mandatory and optional provisions assuming full implementation by all WIC State Agencies. The figures shown here are estimates of the value of full implementation of mandatory and optional provisions assuming no offsetting savings. The figures shown here which are limited to the food benefit, are transfers from the Federal government to WIC participants. Costs VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations Estimate Year dollar Discount rate (percent) 12287 Period covered Qualitative: Local and State WIC agencies will incur some administrative costs, other than reporting and recordkeeping, to implement the final rule. However, we are unable to quantify the potential increases in administrative burden due to the final provisions. These include the costs of training WIC clinic and administrative staff and the periodic review and updating of WIC-approved food lists. The State option to authorize farmers’ markets to accept WIC cash-value vouchers may introduce administrative costs, however in general, we anticipate that State Agencies and local WIC providers will be able to absorb the burden associated with implementing this rule with current NSA funds. State and local agencies have substantial flexibility in how they spend their NSA funds and may need to reprioritize or postpone some initiatives to undertake the implementation activities, as well as adapt to certain ongoing administrative requirements associated with the final rule. FNS will continue to provide technical assistance to State and local agencies to assist them in implementing the new provisions of the final rule. Regulatory Flexibility Act This final rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (RFA) of 1980, (5 U.S.C. 601–612). Pursuant to that review, FNS Administrator Audrey Rowe certified that this rule would not have a significant impact on a substantial number of small entities. State and local agencies and WIC participants will be most affected by the rule and WIC authorized vendors and the food industry may be indirectly affected. Although not required by the RFA, FNS prepared a Regulatory Flexibility Analysis describing the impact of this interim rule on small entities that reflects comments that were received on the Regulatory Flexibility Analysis that was included in the WIC Food Package interim rule published at 72 FR 68982, December 6, 2007. mstockstill on DSK4VPTVN1PROD with RULES2 Need for and Objectives of the Final Rule The interim rule, published in the Federal Register on December 6, 2007 (72 FR 68966), revised the WIC food packages. The revisions align the WIC food packages with the Dietary Guidelines for Americans and infant feeding practice guidelines of the American Academy of Pediatrics. The interim rule revisions largely reflect recommendations made by the Institute of Medicine (IOM) of the National Academies in its report, ‘‘WIC Food Packages: Time for a Change,’’ with certain cost containment and administrative modifications found necessary by the Department to ensure cost neutrality. The interim rule allowed FNS to obtain feedback on the major changes as recommended by IOM, as well as the implementation of procedures, while allowing implementation to move forward. State agencies, including Indian Tribal Organizations, were required to implement the changes by October 1, 2009, and new food packages are now being provided to WIC participants in all States. The interim rule comment period ended February 1, 2010. Public VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 comments received on the interim rule are reflected in the final rule. The interim rule required substantial changes by State and local agencies. Overall, implementation proceeded smoothly and all States have successfully implemented the changes. This final rule makes a much more limited number of modifications than those contained in the interim rule and requires less significant changes in response to the public comments received. Therefore, the expected effects are minimal for FNS and other Federal Agencies. FNS will continue to provide technical assistance to State and local agencies to assist them in fully implementing the changes. This rule will require State and local agencies to make further modifications to their procedures that are far less substantial than the changes required under the Interim rule. Foreign countries will not be affected. Description and Estimate of Number of Small Entities to Which the Final Rule Would Apply This final rule applies to WIC State agencies with respect to their selection of foods to be included on their food lists. As a result, vendors will be indirectly affected. The rule may have an indirect economic affect on certain small businesses because they may have to carry a larger variety of certain foods to be eligible for authorization as a WIC vendor. Currently, approximately 46,000 stores are authorized to accept WIC food instruments, some of which are small businesses. With the high degree of State flexibility allowable under this final rule, small vendors will be impacted differently in each State depending upon how that State chooses to meet the new requirements. Since neither FNS nor the State agencies regulate food producers under the WIC Program, it is not known how many small entities within that industry may be indirectly affected by the final rule. A 2011 evaluation conducted by Altarum Institute 7 sought to understand 7 Altarum Institute 2011. Impact of the Revised WIC Food Package on Small WIC Vendors: Insight from a Four State Evaluation. PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 the impact that the WIC food package changes had on small stores. The study demonstrated that most small WIC stores were able to maintain their authorization with the WIC Program during the period the food package changes were implemented. Small stores appear to have added healthy foods to their inventory in response to the WIC food package changes. The report concludes that adequate vendor preparation likely factored into the overall success of implementation, and cites the need for ongoing engagement of these and other WIC stakeholders. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements Modifications included in the final rule to eliminate certain medical documentation requirements imposed by the interim rule will decrease the Information Collection Burden associated with this rule. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered FNS considered significant alternatives in developing the interim rule including those that may reduce the indirect impact on small business. These considerations included (among others) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for small entities; the use of performance, rather than design, standards; and an exemption from coverage of the rule, or any part thereof, for small entities. In general, the alternatives of exempting small entities from the requirements in the interim rule or altering the requirements for small entities were rejected. The WIC food packages provide supplemental foods designed to address the nutritional needs of low-income pregnant, breastfeeding, non-breastfeeding postpartum women, infants and E:\FR\FM\04MRR2.SGM 04MRR2 12288 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES2 children up to age 5 who are at nutritional risk. Exempting small entities from providing the specific foods intended to address the nutritional needs of participants or altering the requirements for small entities would undermine the purpose of the WIC Program and endanger the health status of participants. Therefore, this final rule retains those requirements. FNS did, however, modify the new food provisions in an effort to mitigate the impact on small entities. As in the past, State agencies must establish minimum requirements for the variety and quantity of foods that a vendor must stock in order to receive WIC Program authorization. The interim rule added new food items, such as fruits and vegetables and whole grain breads, which may require some WIC vendors, particularly smaller stores, to expand the types and quantities of food items stocked in order to maintain their WIC authorization. In addition, vendors also have to make available more than one food type from each WIC food category, except for the categories of peanut butter and eggs, which may be a change for some vendors. To mitigate the impact of the fruit and vegetable requirement, the interim rule allowed canned, frozen and dried fruits and vegetables to be substituted for fresh produce. These provisions are all retained in this final rule. The interim rule authorized State agencies the option to allow participants to pay the difference if the fruit and vegetable purchase exceeds the value of the cash-value voucher, a transaction known as ‘‘split tender.’’ In response to public comments received on the interim rule, this final rule requires State agencies to allow split tender transactions with the cash-value voucher. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104–4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and tribal governments and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with ‘‘Federal mandates’’ that may result in expenditures by State, local or tribal governments, in the aggregate, or the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, Section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 alternatives and adopt the most cost effective or least burdensome alternative that achieves the objectives of the rule. This final rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and tribal governments or the private sector of $100 million or more in any one year. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA. Executive Order 12372 The WIC Program is listed in the Catalog of Federal Domestic Assistance Programs under 10.557. For the reasons set forth in the final rule in 7 CFR part 3015, subpart V, and related Notice (48 FR 29115, June 24, 1983), this program is included in the scope of Executive Order 12372 which requires intergovernmental consultation with State and local officials. Federalism Summary Impact Statement Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency’s considerations in terms of the three categories called for under Section (6)(b)(2)(B) of Executive Order 13121. Prior Consultation With State Officials Since publication of the interim rule revising the WIC food packages, FNS has obtained input from WIC State and local agency staff about the provisions and implementation of the changes. Examples of the different forums and methods FNS has used to solicit WIC State and local agency staff input on the WIC food packages include the following: • Hosting annual meetings of the National Advisory Council on Maternal, Infant and Fetal Nutrition that includes WIC staff as members of the Council; the Council develops recommendations for FNS on how to improve operations of WIC, including aspects related to the authorized foods and food packages; • Consulting and collaborating with the National WIC Association (NWA) on a wide variety of WIC issues, including those related to the WIC food packages. NWA is a non-profit organization that was founded in 1983 by State and local agencies that administer the WIC Program. NWA’s paid membership includes 72 of the 90 WIC State agencies, 813 local agencies, 7 State WIC Associations, and 27 sustaining members (i.e., for-profit and non-profit businesses or organizations). PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 Functioning as a coalition of WIC agencies, NWA is dedicated to maximizing WIC resources through effective management practices. NWA also serves in a leadership role for WIC agencies by developing position papers on issues of concern to the WIC community; and • Regular meetings and consultation with State health officials and other WIC stakeholders, including the medical community, advocacy groups, and retailers. Nature of Concerns and the Need To Issue This Rule This final rule considers public comments submitted in response to the interim rule revising the WIC food packages published in December 2007 (72 FR 68966). The interim rule implemented the first comprehensive revisions to the WIC food packages since 1980. This final rule addresses public comments received on the interim rule and makes adjustments that improve clarity of the provisions set forth in the interim rule. Extent to Which We Meet Those Concerns FNS has considered the impact of final rule on State and local agencies. FNS believes that the rule is responsive to the expressed concerns and requests of commenters representing State and local concerns. Executive Order 12988 This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full and timely implementation. This rule is not intended to have retroactive effect unless so specified in the DATES section of the final rule. Prior to any judicial challenge to the provisions of the final rule, all applicable administrative procedures must be exhausted. Civil Rights Impact Analysis The intent of this final rulemaking is not to limit participation or to have an adverse effect on current participants. FNS does not expect any protected populations to be adversely affected by the implementation of the requirements in this rule. State agencies must ensure participant access to supplemental foods. The foods available to WIC participants as a result of this final rule are intended to broaden the appeal of the WIC food packages for all groups E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES2 and encourage participation in WIC. This final rule revises certain provisions to better address the needs of participants with certain medical conditions, and provides State agencies increased flexibility in prescribing culturally appropriate packages for diverse groups. FNS does not anticipate this rulemaking will result in any adverse civil rights impacts. Executive Order 13175 Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a governmentto-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. In late 2010 and early 2011, USDA engaged in a series of consultative sessions to obtain input by Tribal officials or their designees concerning the impact of this rule on the tribe or Indian Tribal governments, or whether this rule may preempt Tribal law. USDA did not receive any input during these sessions that this rule preempts any Tribal law. Input received relative to this rule included overall satisfaction with the new WIC foods, especially the fruits and vegetables and whole grains, and changes related to supporting breastfeeding mothers. Some tribes reported that WIC participants who were enrolled in WIC during the transition from the previous food packages to the revised food packages expressed displeasure with issuance of lower fat milks and less cheese. The input from Indian tribes during these sessions was consistent with the general comments received for the interim rule, and have been addressed in this final rule. Reports from these consultations will be made part of the USDA annual reporting on Tribal Consultation and Collaboration. USDA will respond in a timely and meaningful manner to all Tribal government requests for consultation concerning this rule and will provide additional venues, such as webinars and teleconferences, to periodically host collaborative conversations with Tribal officials or their designees concerning ways to improve this rule in Indian country. Paperwork Reduction Act of 1995 The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR 1320) requires that the Office of Management VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 and Budget (OMB) approve all collections of information by a Federal agency before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. This final rule changes the information collection burden previously approved under OMB 0584– 0545. Implementation of the data collection requirements resulting from this final rule is contingent upon OMB approval under the Paperwork Reduction Act of 1995. The proposed food package rule was published in the Federal Register [71 FR 44784] with a 60-day notice on August 7, 2006, which provided the public an opportunity to submit comments on the information collection burden resulting from the proposed rule. FNS received no public comments in response to this solicitation. On November 1, 2006, OMB filed comment in accordance with 5 CFR 1320.11(c), requiring FNS to review public comments in response to the proposed rule and address any such comments in the preamble of the final rule. The interim food package rule was published in the Federal Register [72 FR 68966] on December 6, 2007, and included an estimated annual information collection burden of 14,919 burden hours, which was approved as OMB Number 0584–0545. These information collection burden hours were merged into the information collection, WIC Program Reporting and Recordkeeping Requirements, OMB Number 0584–0043, changing the total approved burden hours for OMB Number 0584–0043 from 3,595,075 to 3,609,994. Information collection OMB Number 0584–0545 was then discontinued. Information collection OMB Number 0584–0043 was renewed as of December 27, 2012, changing the total approved burden hours from 3,609,994 to 4,024,697. In this final rule, FNS will no longer require a health care professional licensed to write medical prescriptions to provide documentation for children to receive soy-based beverage and tofu as milk substitutes. Also, FNS will no longer require documentation from a health care professional licensed to write medical prescriptions for women to receive tofu in excess of the maximum substitution allowance. As a result of this final rulemaking, the overall information collection burden associated with OMB Number 0584– 0043 is estimated to have decreased by 4,200 burden hours annually due to program changes in this rulemaking. The total estimated burden hours for PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 12289 OMB Number 0584–0043 will decrease from 4,024,697 to 4,020,497. The breakdown of the changes is described below: OMB Number 0584–0043; WIC Program Reporting and Recordkeeping Requirements; expiration date December 31, 2015. Type of Request: Revision of a currently approved collection. Abstract: Federal regulations at 7 CFR 246.10(d)(1)(vi) and (viii) require medical documentation for the issuance of soy-based beverage and tofu for children, and tofu above the maximum substitution amount for women. Federal regulations at 7 CFR 246.10(d)(1)(v) require medical documentation for the issuance of supplemental foods to participants who receive Food Package III (for participants with qualifying conditions). Under the interim rule, medical documentation by a health care professional licensed to write medical prescriptions is required for the issuance of certain milk alternatives for children and women. A total of 180 comment letters (53 of these form letters) opposed this requirement, primarily the documentation for children to receive soy-based beverage. Commenters stated that the provision is unnecessary, costly and burdensome for participants and physicians, creates barriers to services, and undermines FNS’ efforts to provide foods that meet the cultural needs of participants. The NWA and the American Dietetic Association (now known as the Academy of Nutrition and Dietetics) stressed that WIC dietitians and nutritionists are health professionals trained and capable of doing a complete nutrition assessment, selecting WIC foods, and providing appropriate education to participants and caregivers, in consultation with the health care provider when warranted. Based on the experiences cited by WIC State and local agencies related to medical documentation throughout implementation of the new food packages, FNS will no longer require a health care professional licensed to write medical prescriptions to provide documentation for children to receive soy-based beverage and tofu as milk substitutes. Also, FNS will no longer require documentation from a health care professional licensed to write medical prescriptions for women to receive tofu in excess of the maximum substitution allowance. Estimate of Burden This final rule amends the supplemental foods that require medical documentation as described in 7 CFR E:\FR\FM\04MRR2.SGM 04MRR2 12290 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations 246.10(d)(1) However, medical documentation continues to be required for issuance of supplemental foods in Food Package III. After revising to reflect the changes made by this final rule, the total annual reporting and recordkeeping burden estimated for medical documentation is decreased by 4,200 hours. FNS estimates that approximately 1 percent of participants (89,606) will be issued supplemental foods under Food Package III. FNS estimates that it will take three minutes (0.05 hours) for the documentation required to issue the authorized foods, thus resulting in an estimated reporting burden for participants of 8,961 hours (89,606 total participants × 0.05 person hours × 2 certification periods per year). This results in a decrease in the approved reporting burden under OMB 0584– 0043 for participants providing medical documentation for supplemental foods from 13,160 burden hours to 8,961 burden hours (a decrease of 4,200 burden hours). FNS will submit an Information Collection Request clearance package to OMB based on the provisions of this final rule. These amended information collection requirements will not become effective until approved by OMB. When OMB has approved these information collection requirements, FNS will publish separate action in the Federal Register announcing OMB approval. E-Government Act Compliance The Food and Nutrition Service is committed to complying with the EGovernment Act, 2002, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. List of Subjects in 7 CFR Part 246 mstockstill on DSK4VPTVN1PROD with RULES2 Administrative practice and procedure, Civil rights, Food assistance programs, Grant programs-health, Grant programs-social programs, Indians, Infants and children, Maternal and child health, Nutrition, Penalties, Reporting and recordkeeping requirements, Women. ■ For reasons set forth in the preamble, 7 CFR Part 246 is amended as follows: PART 246—SPECIAL SUPPLEMENTAL NUTRTION PROGRAM FOR WOMEN, INFANTS AND CHILDREN 1. The authority citation for 7 CFR part 246 continues to read as follows: ■ Authority: 42 U.S.C. 1786. ■ 2. In § 246.2: VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 a. Add a definition for ‘‘Farmers’ market’’ in alphabetical order; ■ b. Add a definition for ‘‘Full nutrition benefit’’ in alphabetical order; ■ c. Remove the definition heading ‘‘WIC-eligible medical foods’’ and add in its place ‘‘WIC-eligible nutritionals for participants with qualifying conditions (hereafter referred to as ‘‘WIC-eligible nutritionals)’’; and ■ d. Remove the term ‘‘WIC-eligible medical foods’’ and add in its place the term ‘‘WIC-eligible nutritionals’’ wherever it appears. ■ The revisions and additions read as follows: ■ § 246.2 Definitions. * * * * * Farmers’ market means an association of local farmers who assemble at a defined location for the purpose of selling their produce directly to consumers. * * * * * Full nutrition benefit means the minimum amount of reconstituted fluid ounces of liquid concentrate infant formula as specified in Table 1 of § 246.10(e)(9) for each food package category and infant feeding variation (e.g., Food Package IA fully formula fed, IA–FF). * * * * * ■ 3. In § 246.4: ■ a. Amend paragraph (a)(11)(iii) by removing ‘‘§ 246.10(b)(1)’’ and adding in its place ‘‘§ 246.10(b)(2)(i)’’. ■ b. Revise paragraph (a)(14)(iii); ■ c. Redesignate paragraphs (a)(14)(v) through (xvii) as paragraphs (vi) through (xviii) and add a new paragraph (a)(14)(v); ■ d. Amend newly designated paragraph (a)(14)(vi) by removing ‘‘§ 246.12(k)(1)(i)’’ and adding in its place ‘‘§ 246.12(l)(1)(i)’’; ■ e. Revise newly designated paragraph (a)(14)(xii); and ■ f. Amend paragraph (a)(18) by removing the words ‘‘and food vendors’’ and adding in their place the phrase ‘‘, food vendors, farmers and farmers’ markets’’. The revisions and additions read as follows: § 246.4 State plan. (a) * * * (14) * * * (iii) A sample vendor, farmer and/or farmers’ market, if applicable, agreement. The sample vendor agreement must include the sanction schedule, the process for notification of violations in accordance with § 246.12(l)(3), and the State agency’s policies and procedures on incentive items in accordance with PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 § 246.12(g)(3)(iv), which may be incorporated as attachments or, if the sanction schedule, the process for notification of violations, or policies on incentive items are in the State agency’s regulations, through citations to the regulations. State agencies that intend to delegate signing of vendor, farmer and/ or farmers’ market agreements to local agencies must describe the State agency supervision and instruction that will be provided to ensure the uniformity and quality of local agency activities; * * * * * (v) Farmer monitoring. The system for monitoring farmers and/or farmers’ markets within its jurisdiction, if applicable, for compliance with program requirements; * * * * * (xii) Vendor, farmer and/or farmers’ market training. The procedures the State agency will use to train vendors (in accordance with § 246.12(i)), farmers and/or farmers’ markets (in accordance with § 246.12(v)). State agencies that intend to delegate any aspect of training to a local agency, contractor, vendor or farmer representative must describe the supervision and instructions that will be provided by the State agency to ensure the uniformity and quality of vendor, farmer and/or farmers’ market training; * * * * * ■ 4. In § 246.10: ■ a. Remove the term ‘‘WIC-eligible medical food’’ and add in its place the term ‘‘WIC-eligible nutritional’’ wherever it appears; and remove the term ‘‘WIC-eligible medical foods’’ and replace it with ‘‘WIC-eligible nutritionals’’ wherever it appears; ■ b. Revise paragraph (b)(1)(i); ■ c. Amend paragraph (b)(2)(ii)(C) by removing the words ‘‘age and’’ before ‘‘nutritional’’ and adding the words ‘‘and breastfeeding’’ after ‘‘nutritional’’; ■ d. Amend paragraph (d)(1)(ii) by removing the phrase ‘‘a child’’ and adding in its place the phrase ‘‘an infant, child,’’; ■ e. Remove paragraphs (d)(1)(vi) through (d)(1)(viii); ■ f. Redesignate paragraph (d)(1)(ix) as (d)(1)(vi); ■ g. Revise the heading of paragraph (d)(2); ■ h. Amend paragraph (d)(2)(ii) by adding a space between ‘‘formula’’ and ‘‘and’’; ■ i. Revise paragraph (d)(3)(i); ■ j. Revise paragraph (d)(4)(ii)(D); ■ k. Revise paragraphs (e) introductory text through (e)(1)(iii); ■ l. Revise paragraph (e)(1)(v); ■ m. Revise paragraph (e)(2)(ii); ■ n. Revise paragraph (e)(2)(iv); ■ o. Revise paragraph (e)(3)(v); E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations p. Revise paragraphs (e)(4)(ii) through (e)(7)(ii); and ■ q. Revise paragraphs (e)(9) through (e)(12). The revisions and additions read as follows: ■ § 246.10 Supplemental foods. mstockstill on DSK4VPTVN1PROD with RULES2 * * * * * (b) * * * (1) * * * (i) Establish criteria in addition to the minimum Federal requirements in Table 4 of paragraph (e)(12) of this section for the supplemental foods in their States, except that the State agency may not selectively choose which eligible fruits and vegetables are available to participants. These State agency criteria could address, but not be limited to, other nutritional standards, competitive cost, State-wide availability, and participant appeal. For eligible fruits and vegetables, State agencies may restrict packaging, e.g., plastic containers, and package sizes, such as single serving, of processed fruits and vegetables available for purchase with the cash-value voucher. In addition, State agencies may identify certain processed WIC-eligible fruits and vegetables on food lists where the potential exists for vendor or participant confusion in determining authorized WIC-eligible items. * * * * * (d) * * * (2) Medical documentation for other supplemental foods. * * * (3) * * * (i) Made a medical determination that the participant has a qualifying condition as described in paragraphs (e)(1) through (e)(7) of this section that dictates the use of the supplemental foods, as described in paragraph (d)(1) of this section; and * * * * * (4) * * * (ii) * * * (D) The qualifying condition(s) for issuance of the authorized supplemental food(s) requiring medical documentation, as described in paragraphs (e)(1) through (e)(7) of this section; and * * * * * (e) Food packages. There are seven food packages available under the Program that may be provided to participants. The authorized supplemental foods must be prescribed from food packages according to the category and nutritional needs of the participants. Breastfeeding assessment and the mother’s plans for breastfeeding serve as the basis for determining food package issuance for all breastfeeding VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 women. The intent of the WIC Program is that all breastfeeding women be supported to exclusively breastfeed their infants and to choose the fully breastfeeding food package without infant formula. Breastfeeding mothers whose infants receive formula from WIC are to be supported to breastfeed to the maximum extent possible with minimal supplementation with infant formula. Formula amounts issued to breastfed infants are to be tailored to meet but not exceed the infant’s nutritional needs. The seven food packages are as follows: (1) Food Package I—Infants birth through 5 months.—(i) Participant category served. This food package is designed for issuance to infant participants from birth through age 5 months who do not have a condition qualifying them to receive Food Package III. The following infant feeding variations are defined for the purposes of assigning food quantities and types in Food Packages I: Fully breastfeeding (the infant doesn’t receive formula from the WIC Program); partially (mostly) breastfeeding (the infant is breastfed but also receives infant formula from WIC up to the maximum allowance described for partially (mostly) breastfed infants in Table 1 of paragraph (e)(9) of this section; and fully formula fed (the infant is not breastfed or is breastfed minimally (the infant receives infant formula from WIC in quantities that exceed those allowed for partially (mostly) breastfed infants). (ii) Infant feeding age categories.—(A) Birth to one month. Two infant food packages are available during the first month after birth—fully breastfeeding and fully formula-feeding. State agencies also have the option to make available a third food package containing not more than one can of powder infant formula in the container size that provides closest to 104 reconstituted fluid ounces to breastfed infants on a case-by-case basis. The infant receiving this food package is considered partially breastfeeding. State agencies choosing to make available a partially breastfeeding package in the first month may not standardize issuance of this food package. Infant formula may not be routinely provided during the first month after birth to breastfed infants in order to support the successful establishment of breastfeeding. (B) One through 5 months. Three infant food packages are available from 1 months through 5 months—fully breastfeeding, partially (mostly) breastfeeding, or fully formula-fed. (iii) Infant formula requirements. This food package provides iron-fortified infant formula that is not an exempt PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 12291 infant formula and that meets the requirements in Table 4 of paragraph (e)(12) of this section. The issuance of any contract brand or noncontract brand infant formula that contains less than 10 milligrams of iron per liter (at least 1.5 milligrams iron per 100 kilocalories) at standard dilution is prohibited. Except as specified in paragraph (d) of this section, local agencies must issue as the first choice of issuance the primary contract infant formula, as defined in § 246.2, with all other infant formulas issued as an alternative to the primary contract infant formula. Noncontract brand infant formula and any contract brand infant formula that does not meet the requirements in Table 4 of paragraph (e)(12) of this section may be issued in this food package only with medical documentation of the qualifying condition. A health care professional licensed by the State to write prescriptions must make a medical determination and provide medical documentation that indicates the need for the infant formula. For situations that do not require the use of an exempt infant formula, such determinations include, but are not limited to, documented formula intolerance, food allergy or inappropriate growth pattern. Medical documentation must meet the requirements described in paragraph (d) of this section. * * * * * (v) Authorized category of supplemental foods. Infant formula is the only category of supplemental foods authorized in this food package. Exempt infant formulas and WIC-eligible nutritionals are authorized only in Food Package III. The maximum monthly allowances, allowed options and substitution rates of supplemental foods for infants in Food Packages I are stated in Table 1 of paragraph (e)(9) of this section. (2) * * * (ii) Infant food packages. Three food packages for infants 6 through 11 months are available — fully breastfeeding, partially (mostly) breastfeeding, or fully formula fed. * * * * * (iv) Authorized categories of supplemental foods. Infant formula, infant cereal, and infant foods are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options and substitution rates of supplemental foods for infants in Food Packages II are stated in Table 1 of paragraph (e)(9) of this section. * * * * * (3) * * * E:\FR\FM\04MRR2.SGM 04MRR2 12292 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations (v) Authorized categories of supplemental foods. The supplemental foods authorized in this food package require medical documentation for issuance and include WIC formula (infant formula, exempt infant formula, and WIC-eligible nutritionals), infant cereal, infant foods, milk, cheese, eggs, canned fish, fresh fruits and vegetables, breakfast cereal, whole wheat/whole grain bread, juice, legumes and/or peanut butter. The maximum monthly allowances, allowed options and substitution rates of supplemental foods for infants in Food Package III are stated in Table 1 of paragraph (e)(9) of this section. The maximum monthly allowances, allowed options, and substitution rates of supplemental foods for children and women in Food Package III are stated in Table 3 of paragraph (e)(11) of this section. * * * * * (4) * * * (ii) Authorized categories of supplemental foods. Milk, breakfast cereal, juice, fresh fruits and vegetables, whole wheat/whole grain bread, eggs, and legumes or peanut butter are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options and substitution rates of supplemental foods for children in Food Package IV are stated in Table 2 of paragraph (e)(10) of this section. (5) Food Package V—Pregnant and partially (mostly) breastfeeding women.—(i) Participant category served. This food package is designed for issuance to women participants with singleton pregnancies who do not have a condition qualifying them to receive Food Package III. This food package is also designed for issuance to partially (mostly) breastfeeding women participants, up to 1 year postpartum, who do not have a condition qualifying them to receive Food Package III and whose partially (mostly) breastfed infants receive formula from the WIC program in amounts that do not exceed the maximum allowances described in Table 1 of paragraph (e)(9) of this section. Women participants partially (mostly) breastfeeding more than one infant from the same pregnancy, pregnant women fully or partially breastfeeding singleton infants, and women participants pregnant with two or more fetuses, are eligible to receive Food Package VII as described in paragraph (e)(7) of this section. (ii) Authorized categories of supplemental foods. Milk, breakfast cereal, juice, fresh fruits and vegetables, whole wheat/whole grain bread, eggs, legumes and peanut butter are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options and substitution rates of supplemental foods for women in Food Package V are stated in Table 2 of paragraph (e)(10) of this section. (6) Food Package VI—Postpartum women.—(i) Participant category served. This food package is designed for issuance to women up to 6 months postpartum who are not breastfeeding their infants, and to breastfeeding women up to 6 months postpartum whose participating infant receives more than the maximum amount of formula allowed for partially (mostly) breastfed infants as described in Table 1 of paragraph (e)(9) of this section, and who do not have a condition qualifying them to receive Food Package III. (ii) Authorized categories of supplemental foods. Milk, breakfast cereal, juice, fresh fruits and vegetables, eggs, and legumes or peanut butter are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options and substitution rates of supplemental foods for women in Food Package VI are stated in Table 2 of paragraph (e)(10) of this section. (7) Food Package VII—Fully breastfeeding.—(i) Participant category served. This food package is designed for issuance to breastfeeding women up to 1 year postpartum whose infants do not receive infant formula from WIC (these breastfeeding women are assumed to be exclusively breastfeeding their infants), and who do not have a condition qualifying them to receive Food Package III. This food package is also designed for issuance to women participants pregnant with two or more fetuses, women participants partially (mostly) breastfeeding multiple infants from the same pregnancy, and pregnant women who are also partially (mostly) breastfeeding singleton infants, and who do not have a condition qualifying them to receive Food Package III. Women participants fully breastfeeding multiple infants from the same pregnancy receive 1.5 times the supplemental foods provided in Food Package VII. (ii) Authorized categories of supplemental foods. Milk, cheese, breakfast cereal, juice, fresh fruits and vegetables, whole wheat/whole grain bread, eggs, legumes, peanut butter, and canned fish are the categories of supplemental foods authorized in this food package. The maximum monthly allowances, allowed options and substitution rates of supplemental foods for women in Food Package VII are stated in Table 2 of paragraph (e)(10) of this section. * * * * * (9) Full nutrition benefit and maximum monthly allowances, options and substitution rates of supplemental foods for infants in Food Packages I, II and III are stated in Table 1 as follows: TABLE 1—FULL NUTRITION BENEFIT (FNB) AND MAXIMUM MONTHLY ALLOWANCES (MMA) OF SUPPLEMENTAL FOODS FOR INFANTS IN FOOD PACKAGES I, II AND III Fully formula fed (FF) Food Packages I–FF & III–FF A: 0 through 3 months B: 4 through 5 months mstockstill on DSK4VPTVN1PROD with RULES2 Foods 1 WIC Formula VerDate Mar<15>2010 Partially (mostly) breastfed (BF/FF) 45678 Food Packages II–FF & III–FF 6 through 11 months A: FNB=806 fl oz, MMA=823 fl oz, reconstituted liquid concentrate or 832 fl. oz. RTF or 870 fl oz reconstituted powder. FNB=624 fl oz, MMA=630 fl oz, reconstituted liquid concentrate. or 643 fl. oz RTF or 696 fl oz reconstituted powder. 19:10 Mar 03, 2014 Jkt 232001 PO 00000 Frm 00020 Food Packages I–BF/FF & III BF/FF (A: 0 to 1 month 2 3) B: 1 through 3 months C: 4 through 5 months A: 104 fl oz reconstituted powder. B: FNB=364 fl oz, MMA=388 fl oz, reconstituted liquid concentrate or 384 fl oz RTF or 435 fl oz reconstituted powder. Fmt 4701 Sfmt 4700 Food Packages II–BF/FF & III BF/FF 6 through 11 months FNB=312 fl oz, MMA=315 fl oz, reconstituted liquid concentrate or 338 fl oz RTF or 384 fl oz reconstituted powder. E:\FR\FM\04MRR2.SGM 04MRR2 Fully breastfed (BF) Food Package I–BF 0 through 5 months Food Package II–BF 6 through 11 months Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations 12293 TABLE 1—FULL NUTRITION BENEFIT (FNB) AND MAXIMUM MONTHLY ALLOWANCES (MMA) OF SUPPLEMENTAL FOODS FOR INFANTS IN FOOD PACKAGES I, II AND III—Continued Fully formula fed (FF) Food Packages I–FF & III–FF A: 0 through 3 months B: 4 through 5 months Foods 1 Partially (mostly) breastfed (BF/FF) Food Packages I–BF/FF & III BF/FF (A: 0 to 1 month 2 3) B: 1 through 3 months C: 4 through 5 months Food Packages II–FF & III–FF 6 through 11 months Fully breastfed (BF) Food Packages II–BF/FF & III BF/FF 6 through 11 months Food Package I–BF 0 through 5 months Food Package II–BF 6 through 11 months 24 oz ...................... 128 oz .................... ...................... ...................... 24 oz. 256 oz. ................................ ...................... 77.5 oz. B: FNB=884 fl oz, MMA=896 fl oz, reconstituted liquid concentrate or 913 fl oz RTF or 960 fl oz reconstituted powder. mstockstill on DSK4VPTVN1PROD with RULES2 Infant Cereal 9 11 ....... Infant food fruits and vegetables 9 10 11 12 13. Infant food meat 9 .... ................................ ................................ 24 oz ...................... 128 oz .................... C: FNB=442 fl oz, MMA=460 fl oz, reconstituted liquid concentrate or 474 fl oz RTF or 522 fl oz reconstituted powder. ................................ ................................ ................................ ................................ ................................ Table 1 footnotes: (Abbreviations in order of appearance in table): FF = fully formula fed; BF/FF = partially (mostly) breastfed; BF = fully breastfed; RTF = Ready-to-feed; N/A = the supplemental food is not authorized in the corresponding food package. 1 Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. The competent professional authority (CPA) is authorized to determine nutritional risk and prescribe supplemental foods as established by State agency policy in Food Packages I and II. In Food Package III, the CPA, as established by State agency policy, is authorized to determine nutritional risk and prescribe supplemental foods per medical documentation. 2 State agencies have the option to issue not more than one can of powder infant formula in the container size that provides closest to 104 reconstituted fluid ounces to breastfed infants on a case-by-case basis. 3 Liquid concentrate and ready-to-feed (RTF) may be substituted at rates that provide comparable nutritive value. 4 WIC formula means infant formula, exempt infant formula, or WIC-eligible nutritionals. Infant formula may be issued for infants in Food Packages I, II and III. Medical documentation is required for issuance of infant formula, exempt infant formula, WIC-eligible nutritionals, and other supplemental foods in Food Package III. Only infant formula may be issued for infants in Food Packages I and II. 5 The full nutrition benefit is defined as the minimum amount of reconstituted fluid ounces of liquid concentrate infant formula as specified for each infant food package category and feeding variation (e.g., Food Package IA-fully formula fed). 6 The maximum monthly allowance is specified in reconstituted fluid ounces for liquid concentrate, RTF liquid, and powder forms of infant formula and exempt infant formula. Reconstituted fluid ounce is the form prepared for consumption as directed on the container. 7 State agencies must provide at least the full nutrition benefit authorized to non-breastfed infants up to the maximum monthly allowance for the physical form of the product specified for each food package category. State agencies must issue whole containers that are all the same size of the same physical form. Infant formula amounts for breastfed infants, even those in the fully formula fed category should be individually tailored to the amounts that meet their nutritional needs. 8 State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the full nutrition benefit. State agencies must use the methodology described in accordance with paragraph (h)(1) of this section. 9 State agencies may round up and disperse whole containers of infant foods (infant cereal, fruits and vegetables, and meat) over the Food Package timeframe. State agencies must use the methodology described in accordance with paragraph (h)(2) of this section. 10 At State agency option, for infants 6–12 months of age, fresh banana may replace up to 16 ounces of infant food fruit at a rate of 1 pound of bananas per 8 ounces of infant food fruit. State agencies may also substitute fresh bananas at a rate of 1 banana per 4 ounces of jarred infant food fruit, up to a maximum of 16 ounces. 11 In lieu of infant foods (cereal, fruit and vegetables), infants greater than 6 months of age in Food Package III may receive infant formula, exempt infant formula or WIC-eligible nutritionals at the same maximum monthly allowance as infants ages 4 through 5 months of age of the same feeding option. 12 At State agency option, infants 9 months through 11 months in Food Packages II and III may receive a cash-value voucher to purchase fresh (only) fruits and vegetables in lieu of a portion of the infant food fruits and vegetables. Partially (mostly) breastfed infants and fully formula fed infants may receive a $4 cash-value voucher plus 64 ounces of infant food fruits and vegetables; fully breastfeeding infants may receive a $8 cash-value voucher plus 128 ounces of infant food fruit and vegetables. 13 State agencies may not categorically issue cash-value vouchers for infants 9 months through 11 months. The cash-value voucher is to be provided to the participant only after an individual nutrition assessment, as established by State agency policy, and is optional for the participant, i.e., the mother may choose to receive either the maximum allowance of jarred foods or a combination of jarred foods and a fruit and vegetable cash-value voucher for her infant. State agencies must ensure that appropriate nutrition education is provided to the caregiver addressing safe food preparation, storage techniques, and feeding practices to make certain participants are meeting their nutritional needs in a safe and effective manner. (10) Maximum monthly allowances of supplemental foods in Food Packages IV through VII. The maximum monthly VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 allowances, options and substitution rates of supplemental foods for children PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 and women in Food Package IV through VII are stated in Table 2 as follows: E:\FR\FM\04MRR2.SGM 04MRR2 12294 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations TABLE 2—MAXIMUM MONTHLY ALLOWANCES OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN IN FOOD PACKAGES IV, V, VI AND VII Children Women Foods 1 Food Package IV: 1 through 4 years Food Package V: Pregnant and Partially (Mostly) Breastfeeding (up to 1 year postpartum) 2 Food Package VI: Postpartum (up to 6 months postpartum) 3 Juice, single strength 6 ............. Milk, fluid ................................... Breakfast cereal 13 .................... Cheese ..................................... Eggs .......................................... Fresh fruits and vegetables 14 15 128 fl oz .......................... 16 qt 7 8 9 10 11 ................... 36 oz ............................... N/A .................................. 1 dozen ........................... $8.00 in cash-value vouchers. 2 lb .................................. 144 fl oz .......................... 22 qt 7 8 9 10 12 ................... 36 oz ............................... N/A .................................. 1 dozen ........................... $10.00 in cash-value vouchers. 1 lb .................................. 96 fl oz ............................ 16 qt 7 8 9 10 12 ................... 36 oz ............................... N/A .................................. 1 dozen ........................... $10.00 in cash-value vouchers. N/A .................................. 144 fl oz. 24 qt 7 8 9 10 12. 36 oz. 1 lb. 2 dozen. $10.00 in cash-value vouchers. 1 lb. N/A .................................. 1 lb or 18 oz .................... N/A .................................. 1 lb and 18 oz ................. N/A .................................. 1 lb or 18 oz .................... 30 oz. 1 lb and 18 oz. mstockstill on DSK4VPTVN1PROD with RULES2 Whole wheat or whole grain bread 16. Fish (canned) ............................ Legumes, dry 17 and/or Peanut butter. Food Package VII: Fully Breastfeeding (up to 1 year post-partum) 4 5 Table 2 Footnotes: N/A = the supplemental food is not authorized in the corresponding food package. 1 Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. The competent professional authority (CPA) is authorized to determine nutritional risk and prescribe supplemental foods as established by State agency policy. 2 Food Package V is issued to two categories of WIC participants: Women participants with singleton pregnancies; breastfeeding women whose partially (mostly) breastfed infants receive formula from the WIC Program in amounts that do not exceed the maximum formula allowances, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 3 Food Package VI is issued to two categories of WIC participants: Non-breastfeeding postpartum women and breastfeeding postpartum women whose infants receive more than the maximum infant formula allowances, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 4 Food Package VII is issued to four categories of WIC participants: Fully breastfeeding women whose infants do not receive formula from the WIC Program; women pregnant with two or more fetuses; women partially (mostly) breastfeeding multiple infants from the same pregnancy; and pregnant women who are also fully or partially (mostly) breastfeeding singleton infants. 5 Women fully breastfeeding multiple infants from the same pregnancy are prescribed 1.5 times the maximum allowances. 6 Combinations of single-strength and concentrated juices may be issued provided that the total volume does not exceed the maximum monthly allowance for single-strength juice. 7 Whole milk is the standard milk for issuance to 1-year-old children (12 through 23 months). At State agency option, fat-reduced milks may be issued to 1-year-old children for whom overweight or obesity is a concern. The need for fat-reduced milks for 1-year-old children must be based on an individual nutritional assessment and consultation with the child’s health care provider if necessary, as established by State agency policy. Lowfat (1%) or nonfat milks are the standard milk for issuance to children ≥ 24 months of age and women. Reduced fat (2%) milk is authorized only for participants with certain conditions, including but not limited to, underweight and maternal weight loss during pregnancy. The need for reduced fat (2%) milk for children ≥ 24 months of age (Food Package IV) and women (Food Packages V–VII) must be based on an individual nutritional assessment as established by State agency policy. 8 Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate to fluid milk. 9 For children and women, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. For children and women in Food Packages IV–VI, no more than 1 pound of cheese may be substituted. For fully breastfeeding women in Food Package VII, no more than 2 pounds of cheese may be substituted for milk. State agencies do not have the option to issue additional amounts of cheese beyond these maximums even with medical documentation. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for children and women in Food Packages IV–VI. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in Food Package VII.) 10 For children and women, yogurt may be substituted for fluid milk at the rate of 1 quart of yogurt per 1 quart of milk; a maximum of 1 quart of milk can be substituted. Additional amounts of yogurt are not authorized. Whole yogurt is the standard yogurt for issuance to 1-year-old children (12 through 23 months). At State agency option, lowfat or nonfat yogurt may be issued to 1-year-old children for whom overweight and obesity is a concern. The need for lowfat or nonfat yogurt for 1-year-old children must be based on an individual nutritional assessment and consultation with the child’s health care provider if necessary, as established by State agency policy. Lowfat or nonfat yogurts are the only types of yogurt authorized for children ≥ 24 months of age and women. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for children and women in Food Packages IV–VI. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in Food Package VII.) 11 For children, issuance of tofu and soy-based beverage as substitutes for milk must be based on an individual nutritional assessment and consultation with the participant’s health care provider if necessary, as established by State agency policy. Such determination can be made for situations that include, but are not limited to, milk allergy, lactose intolerance, and vegan diets. Soy-based beverage may be substituted for milk for children on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted for milk for children at the rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for children in Food Package IV.) Additional amounts of tofu may be substituted, up to the maximum allowance for fluid milk for lactose intolerance or other reasons, as established by State agency policy. 12 For women, soy-based beverage may be substituted for milk on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted for milk at the rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in Food Packages V and VI. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in Food Package VII.). Additional amounts of tofu may be substituted, up to the maximum allowances for fluid milk, for lactose intolerance or other reasons, as established by State agency policy. 13 At least one-half of the total number of breakfast cereals on the State agency’s authorized food list must have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat content’’ as defined in Table 4 of paragraph (e)(12) of this section. VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations 12295 14 Both fresh fruits and fresh vegetables must be authorized by State agencies. Processed fruits and vegetables, i.e., canned (shelf-stable), frozen, and/or dried fruits and vegetables may also be authorized to offer a wider variety and choice for participants. State agencies may choose to authorize one or more of the following processed fruits and vegetables: canned fruit, canned vegetables, frozen fruit, frozen vegetables, dried fruit, and/or dried vegetables. The cash-value voucher may be redeemed for any eligible fruit and vegetable (refer to Table 4 of paragraph (e)(12) of this section and its footnotes). Except as authorized in paragraph (b)(1)(i) of this section, State agencies may not selectively choose which fruits and vegetables are available to participants. For example, if a State agency chooses to offer dried fruits, it must authorize all WIC-eligible dried fruits. 15 The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as described in § 246.16(j). 16 Whole wheat and/or whole grain bread must be authorized. State agencies have the option to also authorize brown rice, bulgur, oatmeal, whole-grain barley, whole wheat macaroni products, or soft corn or whole wheat tortillas on an equal weight basis. 17 Canned legumes may be substituted for dry legumes at the rate of 64 oz. (e.g., four 16-oz cans) of canned beans for 1 pound dry beans. In Food Packages V and VII, both beans and peanut butter must be provided. However, when individually tailoring Food Packages V or VII for nutritional reasons (e.g., food allergy, underweight, participant preference), State agencies have the option to authorize the following substitutions: 1 pound dry and 64 oz. canned beans/peas (and no peanut butter); or 2 pounds dry or 128 oz. canned beans/peas (and no peanut butter); or 36 oz. peanut butter (and no beans). (11) Maximum monthly allowances of supplemental foods for children and women with qualifying conditions in Food Package III. The maximum monthly allowances, options and substitution rates of supplemental foods for participants with qualifying conditions in Food Package III are stated in Table 3 as follows: TABLE 3—MAXIMUM MONTHLY ALLOWANCES (MMA) OF SUPPLEMENTAL FOODS FOR CHILDREN AND WOMEN WITH QUALIFYING CONDITIONS IN FOOD PACKAGE III Children Foods 1 1 through 4 years Juice, single strength 6 ........ WIC Formula 7 8 ................... Milk ...................................... Breakfast cereal 15 16 ........... Cheese ................................ Eggs .................................... Fruits and vegetables 17 18 19 mstockstill on DSK4VPTVN1PROD with RULES2 Whole wheat or whole grain bread 20. Fish (canned) ...................... Legumes, dry 21 and/or Peanut butter. Women Pregnant and partially breastfeeding (up to 1 year postpartum) 2 Postpartum (up to 6 months postpartum) 3 Fully breastfeeding, (up to 1 year post-partum) 4 5 128 fl oz ..................... 455 fl oz liquid concentrate. 16 qt 9 10 11 12 13 ........... 36 oz .......................... N/A ............................. 1 dozen ...................... $8.00 in cash-value vouchers. 2 lb ............................. 144 fl oz .............................. 455 fl oz liquid concentrate 96 fl oz ................................ 455 fl oz liquid concentrate 144 fl oz. 455 fl oz liquid concentrate. 22 qt 9 10 11 12 14 .................... 36 oz ................................... N/A ...................................... 1 dozen ............................... $10.00 in cash-value vouchers. 1 lb ...................................... 16 qt 9 10 11 12 14 .................... 36 oz ................................... N/A ...................................... 1 dozen ............................... $10.00 in cash-value vouchers. N/A ...................................... 24 qt 9 10 11 12 14. 36 oz. 1 lb. 2 dozen. $10.00 in cash-value vouchers. 1 lb. N/A ............................. 1 lb ............................. Or ............................... 18 oz .......................... N/A ...................................... 1 lb ...................................... And ...................................... 18 oz ................................... N/A ...................................... 1 lb ...................................... Or ........................................ 18 oz ................................... 30 oz. 1 lb. 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. The competent professional authority (CPA), as established by State agency policy, is authorized to determine nutritional risk and prescribe supplemental foods per medical documentation. 2 This food package is issued to two categories of WIC participants: Women participants with singleton pregnancies and breastfeeding women whose partially (mostly) breastfed infants receive formula from the WIC Program in amounts that do not exceed the maximum formula allowances as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 3 This food package is issued to two categories of WIC participants: Non-breastfeeding postpartum women and breastfeeding postpartum women whose breastfed infants receive more than the maximum infant formula allowances as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 4 This food package is issued to four categories of WIC participants: Fully breastfeeding women whose infants do not receive formula from the WIC Program; women pregnant with two or more fetuses; women partially (mostly) breastfeeding multiple infants from the same pregnancy, and pregnant women who are also partially (mostly) breastfeeding singleton infants. 5 Women fully breastfeeding multiple infants from the same pregnancy are prescribed 1.5 times the maximum allowances. 6 Combinations of single-strength and concentrated juices may be issued provided that the total volume does not exceed the maximum monthly allowance for single-strength juice. 7 WIC formula means infant formula, exempt infant formula, or WIC-eligible nutritionals. 8 Powder and ready-to-feed may be substituted at rates that provide comparable nutritive value. 9 Whole milk is the standard milk for issuance to 1-year-old children (12 through 23 months). Fat-reduced milks may be issued to 1-year old children as determined appropriate by the health care provider per medical documentation. Lowfat (1%) or nonfat milks are the standard milks for issuance for children ≥ 24 months of age and women. Whole milk or reduced fat (2%) milk may be substituted for lowfat (1%) or nonfat milk for children ≥ 24 months of age and women as determined appropriate by the health care provider per medical documentation. 10 Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate to fluid milk. 11 For children and women, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. For children and women in the pregnant, partially breastfeeding and postpartum food packages, no more than 1 pound of cheese may be substituted. For women in the fully breastfeeding food package, no more than 2 pounds of cheese may be substituted for milk. State agencies do not have the option to issue additional amounts of cheese beyond these maximums even with medical documentation. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for children and women in the pregnant, partially breastfeeding and postpartum food packages. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in the fully breastfeeding food package.) VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 E:\FR\FM\04MRR2.SGM 04MRR2 12296 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations 12 For children and women, yogurt may be substituted for fluid milk at the rate of 1 quart of yogurt per 1 quart of milk; a maximum of 1 quart of milk can be substituted. Additional amounts of yogurt are not authorized. Whole yogurt is the standard yogurt for issuance to 1-year-old children (12 through 23 months). Lowfat or nonfat yogurt may be issued to 1-year-old children (12 months to 23 months) as determined appropriate by the health care provider per medical documentation. Lowfat or nonfat yogurts are the standard yogurt for issuance to children ≥ 24 months of age and women. Whole yogurt may be substituted for lowfat or nonfat yogurt for children ≥ 24 months of age and women as determined appropriate by the health care provider per medical documentation. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for children and women in the pregnant, partially breastfeeding and postpartum food packages. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in the fully breastfeeding food package.) 13 For children, soy-based beverage and tofu may be substituted for milk as determined appropriate by the health care provider per medical documentation. Soy-based beverage may be substituted for milk on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted for milk for children at the rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for children.) Additional amounts of tofu may be substituted, up to the maximum allowance for fluid milk for children, as determined appropriate by the health care provider per medical documentation. 14 For women, soy-based beverage may be substituted for milk on a quart for quart basis up to the total maximum monthly allowance of milk. Tofu may be substituted for milk at the rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in the pregnant, partially breastfeeding and postpartum food packages. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in the fully breastfeeding food package.) Additional amounts of tofu may be substituted, up to the maximum allowances for fluid milk, as determined appropriate by the health care provider per medical documentation. 15 32 dry ounces of infant cereal may be substituted for 36 ounces of breakfast cereal as determined appropriate by the health care provider per medical documentation. 16 At least one half of the total number of breakfast cereals on the State agency’s authorized food list must have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat content’’ as defined in Table 4 of paragraph (e)(12) of this section. 17 Both fresh fruits and fresh vegetables must be authorized by State agencies. Processed fruits and vegetables, i.e., canned (shelf-stable), frozen, and/or dried fruits and vegetables may also be authorized to offer a wider variety and choice for participants. State agencies may choose to authorize one or more of the following processed fruits and vegetables: canned fruit, canned vegetables, frozen fruit, frozen vegetables, dried fruit, and/or dried vegetables. The cash-value voucher may be redeemed for any eligible fruit and vegetable (refer to Table 4 of paragraph (e)(12) of this section and its footnotes). Except as authorized in paragraph (b)(1)(i) of this section, State agencies may not selectively choose which fruits and vegetables are available to participants. For example, if a State agency chooses to offer dried fruits, it must authorize all WIC-eligible dried fruits. 18 Children and women whose special dietary needs require the use of pureed foods may receive commercial jarred infant food fruits and vegetables in lieu of the cash-value voucher. Children may receive 128 oz of commercial jarred infant food fruits and vegetables and women may receive 160 oz of commercial jarred infant food fruits and vegetables in lieu of the cash-value voucher. Infant food fruits and vegetables may be substituted for the cash-value voucher as determined appropriate by the health care provider per medical documentation. 19 The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as described in § 246.16(j). 20 Whole wheat and/or whole grain bread must be authorized. State agencies have the option to also authorize brown rice, bulgur, oatmeal, whole-grain barley, whole wheat macaroni products, or soft corn or whole wheat tortillas on an equal weight basis. 21 Canned legumes may be substituted for dry legumes at the rate of 64 oz. (e.g., four 16-oz cans) of canned beans for 1 pound dry beans. In Food Packages V and VII, both beans and peanut butter must be provided. However, when individually tailoring Food Packages V or VII for nutritional reasons (e.g., food allergy, underweight, participant preference), State agencies have the option to authorize the following substitutions: 1 pound dry and 64 oz. canned beans/peas (and no peanut butter); or 2 pounds dry or 128 oz. canned beans/peas (and no peanut butter); or 36 oz. peanut butter (and no beans). (12) Minimum requirements and specifications for supplemental foods. Table 4 describes the minimum requirements and specifications for supplemental foods in all food packages: TABLE 4—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS Categories/foods WIC FORMULA: Infant formula ................ Exempt infant formula ... mstockstill on DSK4VPTVN1PROD with RULES2 WIC-eligible nutritionals.1. Minimum requirements and specifications All authorized infant formulas must: (1) Meet the definition for an infant formula in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and meet the requirements for an infant formula under section 412 of the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107; (2) Be designed for enteral digestion via an oral or tube feeding; (3) Provide at least 10 mg iron per liter (at least 1.5 mg iron/100 kilocalories) at standard dilution; (4) Provide at least 67 kilocalories per 100 milliliters (approximately 20 kilocalories per fluid ounce) at standard dilution. (5) Not require the addition of any ingredients other than water prior to being served in a liquid state. 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. Certain enteral products that are specifically formulated to provide nutritional support for individuals with a qualifying condition, when the use of conventional foods is precluded, restricted, or inadequate. Such WIC-eligible nutritionals must serve the purpose of a food, meal or diet (may be nutritionally complete or incomplete) and provide a source of calories and one or more nutrients; be designed for enteral digestion via an oral or tube feeding; and may not be a conventional food, drug, flavoring, or enzyme. MILK AND MILK ALTERNATIVES: VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations 12297 TABLE 4—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS—Continued Categories/foods Cow’s milk 2 ...................... Goat’s milk ........................... Cheese ................................. Yogurt (cow’s milk) ............... Tofu ...................................... Soy-based beverage ............ JUICE ................................... EGGS ................................... BREAKFAST CEREAL (READY-TO-EAT AND INSTANT AND REGULAR HOT CEREALS). mstockstill on DSK4VPTVN1PROD with RULES2 FRUITS AND VEGETABLES (FRESH AND PROCESSED) 4 5 6 8 9. WHOLE WHEAT BREAD, WHOLE GRAIN BREAD, AND WHOLE GRAIN OPTIONS: Bread ............................. VerDate Mar<15>2010 19:10 Mar 03, 2014 Minimum requirements and specifications Must conform to FDA standard of identity for whole, reduced fat, lowfat, or nonfat milks (21 CFR 131.110). Must be pasteurized. May be flavored or unflavored. May be fluid, shelf-stable, evaporated (21 CFR 131.130), or dry. Dry whole milk must conform to FDA standard of identity (21 CFR 131.147). Nonfat dry milk must conform to FDA standard of identity (21 CFR 131.127). Cultured milks must conform to FDA standard of identity for cultured milk, e.g. cultured buttermilk, kefir cultured milk, acidophilus cultured milk (21 CFR 131.112). Acidified milk must conform to FDA standard of identity for acidified milk, e.g., acidified kefir milk, acidified acidophilus milk or acidified buttermilk (21 CFR 131.111). All reduced fat, lowfat, and nonfat cow’s milk types and varieties must contain at least 400 IU of vitamin D per quart (100 IU per cup) and 2000 IU of vitamin A per quart (500 IU per cup). Must be pasteurized. May be flavored or unflavored. May be fluid, shelf-stable, evaporated or dry (i.e., powdered). All reduced fat, lowfat, and nonfat goat’s milk must contain at least 400 IU of vitamin D per quart (100 IU per cup) and 2000 IU of vitamin A per quart (500 IU per cup). Domestic cheese made from 100 percent pasteurized milk. Must conform to FDA standard of identity (21 CFR part 133); Monterey Jack, Colby, natural Cheddar, Swiss, Brick, Muenster, Provolone, part-skim or whole Mozzarella, pasteurized process American, or blends of any of these cheeses are authorized. Cheeses that are labeled low, free, reduced, less or light in sodium, fat or cholesterol are WIC eligible. Yogurt must be pasteurized and conform to FDA standard of identity for whole fat (21 CFR 131.200), lowfat (21 CFR 131.203), or nonfat (21 CFR 131.206); plain or flavored with ≤40 g of total sugars per 1 cup yogurt. Yogurts that are fortified with vitamin A and D and other nutrients may be allowed at the State agency’s option. Yogurts sold with accompanying mix-in ingredients such as granola, candy pieces, honey, nuts and similar ingredients are not authorized. Drinkable yogurts are not authorized. 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. 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. Must be pasteurized 100% unsweetened fruit juice. Must contain at least 30 mg of vitamin C per 100 mL of juice. Must conform to FDA standard of identity as appropriate (21 CFR part 146) or vegetable juice must conform to FDA standard of identity as appropriate (21 CFR part 156). With the exception of 100% citrus juices, State agencies must verify the vitamin C content of all State-approved juices. Juices that are fortified with other nutrients may be allowed at the State agency’s option. Juice may be fresh, from concentrate, frozen, canned, or shelf-stable. Blends of authorized juices are allowed. Vegetable juice may be regular or lower in sodium. 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. 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’’.3 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); without added sugars, fats, oils, or salt (i.e., sodium). Any type of immature beans, peas, or lentils, fresh or in canned 5 forms. Any type of frozen beans (immature or mature). Beans purchased with the CVV may contain added vegetables and fruits, but may not contain added sugars, fats, oils, or meat as purchased. Canned beans, peas, or lentils may be regular or lower in sodium content. State agencies must allow organic forms of WIC-eligible fruits and vegetables. Whole wheat bread must conform to FDA standard of identity (21 CFR 136.180). (Includes whole wheat buns and rolls.) ‘‘Whole wheat flour’’ and/or ‘‘bromated whole wheat flour’’ must be the only flours listed in the ingredient list. Jkt 232001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 E:\FR\FM\04MRR2.SGM 04MRR2 12298 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations TABLE 4—MINIMUM REQUIREMENTS AND SPECIFICATIONS FOR SUPPLEMENTAL FOODS—Continued Categories/foods Whole Grain Options .... FISH (CANNED) 5 ................ MATURE LEGUMES (DRY BEANS AND PEAS) 7. PEANUT BUTTER ............... INFANT FOODS: Infant Cereal ................. Infant Fruits ................... Infant Vegetables .......... mstockstill on DSK4VPTVN1PROD with RULES2 Infant Meat .................... Minimum requirements and specifications OR Whole grain bread must conform to FDA standard of identity (21 CFR 136.110) (includes whole grain buns and rolls). AND Whole grain must be the primary ingredient by weight in all whole grain bread products. AND Must meet FDA labeling requirements for making a health claim as a ‘‘whole grain food with moderate fat content’’.3 Brown rice, bulgur, oats, and whole-grain barley without added sugars, fats, oils, or salt (i.e., sodium). May be instant-, quick-, or regular-cooking. Soft corn or whole wheat tortillas. Soft corn tortillas made from ground masa flour (corn flour) using traditional processing methods are WIC-eligible, e.g., whole corn, corn (masa), whole ground corn, corn masa flour, masa harina, and white corn flour. For whole wheat tortillas, ‘‘whole wheat flour’’ must be the only flour listed in the ingredient list. Whole wheat macaroni products. Must conform to FDA standard of identity (21 CFR 139.138) and have no added sugars, fats, oils, or salt (i.e., sodium). ‘‘Whole wheat flour’’ and/or ‘‘whole durum wheat flour’’ must be the only flours listed in the ingredient list. Other shapes and sizes that otherwise meet the FDA standard of identity for whole wheat macaroni (pasta) products (139.138), and have no added sugars, fats, oils, or salt (i.e., sodium), are also authorized (e.g., whole wheat rotini, and whole wheat penne). Canned only: Light tuna (must conform to FDA standard of identity (21 CFR 161.190)); Salmon (Pacific salmon must conform to FDA standard of identity (21 CFR 161.170)); Sardines; and Mackerel (N. Atlantic Scomber scombrus; Chub Pacific Scomber japonicas; Jack Mackerel 10 May be packed in water or oil. Pack may include bones or skin. Added sauces and flavorings, e.g., tomato sauce, mustard, lemon, are authorized at the State agency’s option. May be regular or lower in sodium content. Any type of mature dry beans, peas, or lentils in dry-packaged or canned 5 forms. Examples include but are not limited to black beans, black-eyed peas, garbanzo beans (chickpeas), great northern beans, white beans (navy and pea beans), kidney beans, mature lima (‘‘butter beans’’), fava and mung beans, pinto beans, soybeans/ edamame, split peas, lentils, and refried beans. All categories exclude soups. May not contain added sugars, fats, oils, vegetables, fruits or meat as purchased. Canned legumes may be regular or lower in sodium content.11 Baked beans may only be provided for participants with limited cooking facilities.11 Peanut butter 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 cereal must contain a minimum of 45 mg of iron per 100 g of dry cereal.12 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 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 Any variety of commercial infant food meat or poultry, as a single major ingredient, with added broth or gravy. Added sugars or salt (i.e. sodium) are not allowed. Texture may range from pureed through diced.15 Table 4 Footnotes: FDA = Food and Drug Administration of the U.S. Department of Health and Human Services. 1 The following are not considered a WIC-eligible nutritional: Formulas used solely for the purpose of enhancing nutrient intake, managing body weight, addressing picky eaters or used for a condition other than a qualifying condition (e.g., vitamin pills, weight control products, etc.); medicines or drugs, as defined by the Food, Drug and Cosmetic Act (21 U.S.C. 350a) as amended; enzymes, herbs, or botanicals; oral rehydration fluids or electrolyte solutions; flavoring or thickening agents; and feeding utensils or devices (e.g., feeding tubes, bags, pumps) designed to administer a WIC-eligible formula. 2 All authorized milks must conform to FDA standards of identity for milks as defined by 21 CFR part 131 and meet WIC’s requirements for vitamin fortification as specified in Table 4 of paragraph (e)(12) of this section. Additional authorized milks include, but are not limited to: calciumfortified, lactose-reduced and lactose-free, organic and UHT pasteurized milks. Other milks are permitted at the State agency’s discretion provided that the State agency determines that the milk meets the minimum requirements for authorized milk. 3 FDA Health Claim Notification for Whole Grain Foods with Moderate Fat Content at https://www.fda.gov/food/ingredientspackaginglabeling/ labelingnutrition/ucm073634.htm 4 Processed refers to frozen, canned,5 or dried. 5 ‘‘Canned’’ refers to processed food items in cans or other shelf-stable containers, e.g., jars, pouches. 6 The following are not authorized: herbs and spices; creamed vegetables or vegetables with added sauces; mixed vegetables containing noodles, nuts or sauce packets, vegetable-grain (pasta or rice) mixtures; fruit-nut mixtures; breaded vegetables; fruits and vegetables for purchase on salad bars; peanuts or other nuts; ornamental and decorative fruits and vegetables such as chili peppers on a string; garlic on a string; gourds; painted pumpkins; fruit baskets and party vegetable trays; decorative blossoms and flowers, and foods containing fruits such as blueberry muffins and other baked goods. Home-canned and home-preserved fruits and vegetables are not authorized. 7 Mature legumes in dry-packed or canned forms may be purchased with the WIC food instrument only. Immature varieties of fresh or canned beans and frozen beans of any type (immature or mature) may be purchased with the cash-value voucher only. Juices are provided as separate food WIC categories and are not authorized under the fruit and vegetable category. 8 Excludes white potatoes, mixed vegetables containing white potatoes, dried white potatoes; catsup or other condiments; pickled vegetables; olives; soups; juices; and fruit leathers and fruit roll-ups. Canned tomato sauce, tomato paste, salsa and spaghetti sauce without added sugar, fats, or oils are authorized. 9 State agencies have the option to allow only lower sodium canned vegetables for purchase with the cash-value voucher. 10 FDA defines jack mackerel as any of the following six species: Trachurus declivis, trachurus japonicas, trachurur symmetricus, trachurus murphyi, trachurus novaezelandiae, and trachurus lathami in The Seafood List at https://www.fda.gov/Food/GuidanceRegulation/ GuidanceDocumentsRegulatoryInformation/Seafood/ucm113260.htm. King mackerel is not authorized. VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 E:\FR\FM\04MRR2.SGM 04MRR2 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations 12299 11 The following are not authorized in the mature legume category: soups; immature varieties of legumes, such as those used in canned green peas, green beans, snap beans, yellow beans, and wax beans; baked beans with meat, e.g., beans and franks; and beans containing added sugars (with the exception of baked beans), fats, oils, meats, fruits or vegetables. 12 Infant cereals containing infant formula, milk, fruit, or other non-cereal ingredients are not allowed. 13 Mixtures with cereal or infant food desserts (e.g., peach cobbler) are not authorized; however, combinations of single ingredients (e.g., apple-banana) and combinations of single ingredients of fruits and/or vegetables (e.g., apples and squash) are allowed. 14 Combinations of single ingredients (e.g., peas and carrots) and combinations of single ingredients of fruits and/or vegetables (e.g., apples and squash) are allowed. Mixed vegetables with white potato as an ingredient (e.g., mixed vegetables) are authorized. Infant foods containing white potatoes as the primary ingredient are not authorized. 15 No infant food combinations (e.g., meat and vegetables) or dinners (e.g., spaghetti and meatballs) are allowed. 5. In § 246.12: a. Remove the phrase ‘‘WIC-eligible medical foods’’ and add in its place ‘‘WIC-eligible nutritionals’’ wherever it appears; ■ b. Amend paragraph (a)(1) by removing the words ‘‘and farmers’’ after ‘‘vendors’’ in the second sentence and adding in their place the phrase ‘‘, farmers and farmers’ markets,’’; ■ c. Amend paragraphs (f)(2)(ii) and (f)(2)(iv) by removing the word ‘‘vouchermay’’ and adding in its place the words ‘‘voucher may’’ whenever it appears in these paragraphs; ■ d. Add a new paragraph (f)(4); ■ e. Amend paragraph (g)(3)(i) by removing the words ‘‘varieties of’’ in both places that it appears in the second sentence and adding in their place the word ‘‘different’’; ■ f. Amend paragraph (h)(3)(i) by removing the word ‘‘vouchersonly’’ and adding in its place the words ‘‘vouchers only’’; ■ g. Amend paragraph (h)(3)(vii) by adding the words ‘‘, or cash-value vouchers’’ after the word ‘‘instruments’’; ■ h. Revise the heading and the first two sentences of paragraph (h)(3)(viii); ■ i. Amend paragraph (h)(3)(x) by removing the last sentence of the paragraph; ■ j. Redesignate paragraphs (h)(3)(xi) through (h)(3)(xxv) as paragraphs (h)(3)(xii) through (h)(3)(xxvi) and add a new paragraph (h)(3)(xi); ■ k. Amend paragraph (l)(1)(ii)(A) by adding the words ‘‘, or cash-value vouchers,’’ after the word ‘‘instruments’’; ■ l. Revise paragraph (o); ■ m. Amend paragraphs (r)(3) and (t) by adding the phrase ‘‘, farmers’ markets,’’ after the word ‘‘farmer’’; ■ n. Amend paragraph (u)(5) by adding the words ‘‘, farmers, farmers’ markets,’’ after the word ‘‘contractors’’; ■ o. Revise the heading and introductory text of paragraph (v); ■ p. Amend paragraph (v)(1) by adding the words ‘‘or farmers’ market’’ after the word ‘‘farmer’’; ■ q. Revise paragraph (v)(1)(iv); ■ r. Amend paragraphs (v)(2) through (v)(6) by adding the words ‘‘or farmers’ market’’ after the word ‘‘farmer’’ wherever it occurs; ■ s. Revise paragraph (v)(3); mstockstill on DSK4VPTVN1PROD with RULES2 ■ ■ VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 t. Redesignate paragraphs (v)(4) through (v)(6) as paragraphs (v)(5) through (v)(7), and add a new paragraph (v)(4); and ■ u. Add a new paragraph (v)(8). The revisions and additions read as follows: ■ § 246.12 Food delivery systems. * * * * * (f) * * * (4) Split tender transactions. The State agency must implement procedures that allow the participant, authorized representative or proxy to pay the difference when a fruit and vegetable purchase exceeds the value of the cash-value vouchers. * * * * * (h) * * * (3) * * * (viii) Food instrument and cash-value voucher redemption. The vendor must submit food instruments and cash-value vouchers for redemption in accordance with the redemption procedures described in the vendor agreement. The vendor may redeem a food instrument or cash-value voucher only within the specified time period. * * * (xi) Split tender for cash-value vouchers. The vendor must allow the participant, authorized representative or proxy to pay the difference when a fruit and vegetable purchase exceeds the value of the cash-value vouchers (also known as a split tender transaction). * * * * * (o) Participant parent/caretaker, proxy, vendor, farmer, farmers’ market, and home food delivery contractor complaints. The State agency must have procedures to document the handling of complaints by participants, parents or caretakers of infant or child participants, proxies, vendors, farmers, farmers’ markets, home food delivery contractors, and direct distribution contractors. Complaints of civil rights discrimination must be handled in accordance with § 246.8(b). * * * * * (v) Farmers and farmers’ markets. The State agency may authorize farmers, farmers’ markets, and/or roadside stands to accept the cash-value voucher for eligible fruits and vegetables. The State agency must enter into written PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 agreements with all authorized farmers and/or farmers’ markets. The agreement must be signed by a representative who has legal authority to obligate the farmer or farmers’ market and a representative of the State agency. The agreement must be for a period not to exceed 3 years. Only farmers or farmers’ markets authorized by the State agency may redeem the fruit and vegetable cashvalue voucher. The State agency must require farmers or farmers’ markets to reapply at the expiration of their agreements and must provide farmers or farmers markets with not less than 15 days advance written notice of the expiration of the agreement. * * * * * (1) * * * (iv) Redeem the cash-value voucher in accordance with a procedure established by the State agency. Such procedure must include a requirement for the farmer or farmers’ market to allow the participant, authorized representative or proxy to pay the difference when the purchase of fruits and vegetables exceeds the value of the cash-value vouchers (also known as a split tender transaction); * * * * * (3) Neither the State agency nor the farmer or farmers’ market has an obligation to renew the agreement. The State agency, the farmer, or farmers’ market may terminate the agreement for cause after providing advance written notification. (4) Farmer agreements for State agencies that do not authorize farmers. Those State agencies which authorize farmers’ markets but not individual farmers shall require authorized farmers’ markets to enter into a written agreement with each farmer within the market that is authorized to accept cashvalue vouchers. The State agency shall set forth the required terms for the written agreement as defined in § 246.12(v)(1) and (v)(2), and provide a sample agreement for use by the farmers’ market. * * * * * (8) Monitoring farmers and farmers’ markets.—(i) The State agency must design and implement a system for monitoring its authorized farmers and farmers’ markets for compliance with E:\FR\FM\04MRR2.SGM 04MRR2 12300 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Rules and Regulations program requirements. The State agency must document, at a minimum, the following information for all monitoring visits: name(s) of the farmer, farmers market, or roadside stand; name(s) and signature(s) of the reviewer(s); date of review; and nature of problem(s) detected. (ii) Compliance buys. For compliance buys, the State agency must also document: (A) The date of the buy; (B) A description of the farmer (and farmers’ market, as appropriate) involved in each transaction; (C) The types and quantities of items purchased, current retail prices or prices charged other customers, and price charged for each item purchased, if available. Price information may be obtained prior to, during, or subsequent to the compliance buy; and (D) The final disposition of all items as destroyed, donated, provided to other authorities, or kept as evidence. ■ 6. In § 246.16, revise paragraph (j)(2) to read as follows: § 246.16 Distribution of funds. * * * * (j) * * * (2) Base value of the fruit and vegetable voucher. The base year for calculation of the value of the fruit and vegetable voucher is fiscal year 2008. The base value to be used equals: (i) $8 for children; and (ii) $10 for women. * * * * * ■ 7. In § 246.18: ■ a. Revise paragraph (a)(4); ■ b. Amend paragraphs (b), (d), (e), and (f) by adding the phrase ‘‘or farmers’ market’’ after the word ‘‘farmer’’ whenever it appears; ■ c. Revise the first sentence in paragraph (b)(9); ■ d. Amend paragraph (c) introductory text by adding the phrase ‘‘, farmer, or farmers’ market’’ after the word ‘‘vendor’’ in the last sentence; and mstockstill on DSK4VPTVN1PROD with RULES2 * VerDate Mar<15>2010 19:10 Mar 03, 2014 Jkt 232001 e. Revise paragraph (c)(2); The revisions and additions read as follows: ■ § 246.18 Administrative review of State agency actions. (a) * * * (4) Farmer or farmers’ market appeals.—(i) Adverse actions. The State agency shall provide a hearing procedure whereby farmers or farmers’ markets adversely affected by certain actions of the State agency may appeal those actions. A farmer or farmers’ market may appeal an action of the State agency denying its application to participate, imposing a sanction, or disqualifying it from participation in the program. Expiration of an agreement is not subject to appeal. (ii) Effective date of adverse actions against farmers or farmers’ markets. The State agency must make denials of authorization and disqualifications effective on the date of receipt of the notice of adverse action. The State agency must make all other adverse actions effective no earlier than 15 days after the date of the notice of the adverse action and no later than 90 days after the date of the notice of adverse action or, in the case of an adverse action that is subject to administrative review, no later than the date the farmer receives the review decision. The State agency must make all other adverse actions effective no earlier than 15 days after the date of the notice of adverse action and no later than 90 days after the date of the notice of adverse action or, in the case of an adverse action that is subject to an administrative review, no later than the date the farmer or farmers’ market receives the review decision. (b) * * * (9) Written notification of the review decision, including the basis for the decision, within 90 days from the date of receipt of the request for an administrative review from a vendor, farmer, or farmer’s market, and within PO 00000 Frm 00028 Fmt 4701 Sfmt 9990 60 days from the date of receipt of a local agency’s request for an administrative review. * * * (c) * * * (2) A decision-maker who is someone other than the person who rendered the initial decision on the action and whose determination is based solely on whether the State agency has correctly applied Federal and State statutes, regulations, policies, and procedures governing the Program, according to the information provided to the vendor, farmer, or farmers’ market concerning the cause(s) for the adverse action and the response from the vendor, farmer, or farmers’ market. * * * * * ■ 8. In § 246.23: ■ a. Amend paragraph (a)(1) by removing the words ‘‘or food instruments’’ and by adding in its place the phrase ‘‘food instruments, or cashvalue vouchers’’; and ■ b. Revise paragraph (a)(2). The revisions read as follows: § 246.23 Claims and penalties. (a) * * * (2) If FNS determines that any part of the Program funds received by a State agency; or supplemental foods, either purchased or donated commodities; or food instruments or cash-value vouchers, were lost as a result of thefts, embezzlements, or unexplained causes, the State agency shall, on demand by FNS, pay to FNS a sum equal to the amount of the money or the value of the supplemental foods, food instruments, or cash-value vouchers so lost. * * * * * Dated: February 20, 2014. Janey Thornton, Acting Under Secretary, Food, Nutrition, and Consumer Services. [FR Doc. 2014–04105 Filed 2–28–14; 8:45 am] BILLING CODE 3410–30–P E:\FR\FM\04MRR2.SGM 04MRR2

Agencies

[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Rules and Regulations]
[Pages 12273-12300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04105]

[[Page 12273]]

Vol. 79

Tuesday,

No. 42

March 4, 2014

Part II

Department of Agriculture

-----------------------------------------------------------------------

Food and Nutrition Service

7 CFR Part 246

-----------------------------------------------------------------------

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

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

[[Page 12274]]

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food and Nutrition Service

7 CFR Part 246

[FNS-2006-0037]
RIN 0584-AD77

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

AGENCY: Food and Nutrition Service (FNS), USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule considers public comments submitted in
response to the interim rule revising the WIC food packages published
on December 6, 2007. The interim rule implemented the first
comprehensive revisions to the WIC food packages since 1980. The
interim rule revised regulations governing the WIC food packages to
align them more closely with updated nutrition science and the infant
feeding practice guidelines of the American Academy of Pediatrics,
promote and support more effectively the establishment of successful
long-term breastfeeding, provide WIC participants with a wider variety
of food, and provide WIC State agencies with greater flexibility in
prescribing food packages to accommodate participants with cultural
food preferences. This rule makes adjustments that improve clarity of
the provisions set forth in the interim rule.

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

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

SUPPLEMENTARY INFORMATION:

I. Overview

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

II. Background

An interim rule revising the WIC food packages was published in the
Federal Register on December 6, 2007 (72 FR 68966). The interim rule
implemented the first comprehensive revisions to the WIC food packages
since 1980 and largely reflected recommendations made by the National
Academies' Institute of Medicine (IOM) in its Report ``WIC Food
Packages: Time for a Change'' (``Report'').\1\ The interim rule aligned
the food packages more closely with updated nutrition science, promoted
and supported more effectively the establishment of successful long-
term breastfeeding, provided WIC participants with a wider variety of
food, and provided WIC State agencies with greater flexibility in
prescribing food packages to accommodate participants with cultural
food preferences. WIC State agencies were required to implement the
changes by October 1, 2009.
---------------------------------------------------------------------------

\1\ Institute of Medicine, National Academy of Sciences. ``WIC
Food Packages: Time for a Change,'' 2005. Available at Internet
site: https://www.fns.usda.gov/wic-food-packages-time-change.
---------------------------------------------------------------------------

III. General Summary of Comments Received on the Interim Rule To Revise
the WIC Food Packages

The interim rule revising the WIC food packages provided an
extensive public comment period to obtain comments on the impact of the
changes experienced during implementation of the new food packages. The
interim rule comment period ended February 1, 2010.
A total of 7,764 comment letters were received on the interim rule;
of those, 111 were form letters. A total of 6,664 of the letters were
from program participants, and included comments submitted in Spanish,
Chinese, and other languages, in addition to English. The remaining
comment letters were submitted from a variety of sources, including WIC
State and local agencies and Indian Tribal Organizations, the National
WIC Association (NWA), professional organizations and associations,
advocacy groups, healthcare professionals (including universities),
members of Congress, the food industry, vendors, farmers, and private
citizens.
In general, commenters expressed broad support for the changes and
reported relatively smooth implementation of the new WIC food packages.
Commenters also voiced concerns about various aspects of the interim
rule and made recommendations for clarifying or improving specific
provisions of the interim rule. Overall, participants expressed
overwhelming support for the revised WIC food packages, especially the
addition of whole grains and fruits and vegetables. However, many
participants who were enrolled in WIC during the transition from the
previous food packages to the revised food packages expressed
displeasure with changes to fat-reduced milks and less cheese.
FNS considered all timely comments without regard to whether they
were provided by a single commenter or repeated by many. Importance was
given to the substance or content of the comment, rather than the
number of times a comment was submitted.
WIC State agencies are to be commended for the staff and vendor
training that led to successful implementation of the new WIC food
packages, as well as nutrition education provided to participants on
the benefits of the new foods in the WIC food packages. Successful
implementation of the new WIC food packages was further enhanced by the
efforts of WIC's partners in the advocacy, retail, and medical
communities.

IV. Discussion of the Final Rule Provisions

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

[[Page 12275]]

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

A. Definitions

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

B. General Provisions That Affect All WIC Food Packages

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

[[Page 12276]]

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

[[Page 12277]]

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

C. Supplemental Foods and Food Packages

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

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

[[Page 12278]]

without added sugar, fats, and oils are also authorized.
This final rule clarifies that the fruit or vegetable must be
listed as the first ingredient in WIC-eligible processed fruits and
vegetables. In addition, it clarifies that frozen fruits may not
contain added fats, oils, salt (i.e., sodium) or added sugars.
For the reasons described in section IV.B.4 of this preamble, Table
4 of 7 CFR 246.10(e)(12) will be revised to allow State agencies the
option to offer only lower sodium canned vegetables for purchase with
the cash-value voucher.
c. White Potatoes
The interim rule excludes the purchase of white potatoes with the
cash-value voucher. A total of 266 (of these, 213 were form letters)
opposed the restriction of white potatoes. Commenters stated that white
potatoes should be included in the WIC food packages because they are
versatile, economical, contain key nutrients, and are preferred by
participants. Thirty-two commenters (20 form letters) stated that the
exclusion of white potatoes is difficult to administer.
The restriction of white potatoes, as recommended by the IOM, is
based on data indicating that consumption of starchy vegetables meets
or exceeds recommended amounts, and food intake data showing that white
potatoes are the most widely used vegetable. Including white potatoes
in the WIC food packages would not contribute towards meeting the
nutritional needs of the WIC population and would not support the goal
of expanding the types and varieties of fruits and vegetables available
to program participants, as recommended by the IOM. Therefore, the
provision to exclude white potatoes from the WIC food packages is
retained in this final rule. The Department recognizes that white
potatoes can be a healthful part of one's diet. However, WIC food
packages are carefully designed to address the supplemental nutritional
needs of a specific population. Although white potatoes are not offered
in the WIC food package, nutrition education provided to WIC
participants will continue to include white potatoes as a healthy
source of nutrients and an important part of a healthful diet.
d. Dried Fruit and Dried Vegetables for Children
As recommended by the IOM, the interim rule disallows dried fruits
and vegetables to be purchased with the cash-value voucher for children
because of the risk of choking. FNS received a small number of comments
asking that dried fruits be allowed for children, citing a lack of
evidence that they pose choking hazards for all children.
Recommendations made by IOM for the Child and Adult Care Food Program
allow dried fruits for children as long as they do not pose a choking
hazard.\2\ Therefore, at the State agency's option, this final rule
authorizes dried fruits and dried vegetables to be purchased with the
cash-value voucher for children. Nutrition education regarding choking
hazards, developmental readiness, proper food preparation, and oral
health care should be provided to caregivers of young children.
---------------------------------------------------------------------------

\2\ Institute of Medicine, National Academy of Sciences. ``Child
and Adult Care Food Program: Aligning Dietary Guidance for All,''
2010. Available at Internet site: https://www.fns.usda.gov/child-and-adult-care-food-program-aligning-dietary-guidance-all.
---------------------------------------------------------------------------

e. Standards of Identity for Canned Fruits and Canned Vegetables
Two technical corrections have been in made in Table 4 of 7 CFR
246.10(e)(12) related to the standards of identity for canned fruits
and canned vegetables. This final rule corrects the specifications for
WIC-eligible canned fruits to reflect that only those WIC-eligible
canned fruits that have a standard of identity, as listed at 21 CFR
Part 145, must conform to the FDA standard of identity. Similarly, this
final rule corrects the specifications for WIC-eligible canned
vegetables to reflect that only those WIC-eligible canned vegetables
that have a standard of identity, as listed at 21 CFR Part 155, must
conform to the FDA standard of identity. The provision that WIC-
eligible canned vegetables contain no added sugars, fats, and oils
remains unchanged. This final rule clarifies that home-canned and home-
preserved fruits and vegetables are not authorized.
f. Implementation of Fruit and Vegetable Options
(1) Paying the difference with the cash-value voucher. The interim
rule authorized State agencies the option to allow participants to pay
the difference if the fruit and vegetable purchase exceeds the value of
the cash-value voucher, a transaction known as ``split tender.'' A
total of 116 commenters (59 form letters) asked FNS to require all
State agencies to allow split tender transactions to ensure that
participants are able to maximize use of their cash-value voucher.
Because it may be difficult for participants to accurately estimate the
exact purchase price of the fruit and vegetable selections,
particularly when fresh, canned, dried, or frozen items are combined in
one purchase or when items are purchased in bulk, FNS agrees that all
participants should be allowed to pay the difference when the purchase
of allowable fruits and vegetables exceeds the value of the fruit/
vegetable cash-value voucher. Therefore, this final rule adds a
provision at 7 CFR 246.12(f)(4) to require State agencies to allow
split tender transactions with the cash-value voucher.
(2) Minimum vendor stocking requirements. A technical oversight in
the interim rule has been corrected at 7 CFR 246.12(g)(3)(i) by
clarifying that authorized vendors must stock at least two different
fruits and two different vegetables.
(3) Authorizing farmers' markets. The interim rule gave State
agencies the option to allow farmers at farmers' markets to accept
cash-value vouchers. FNS received 29 comments (mostly form letters)
recommending that farmers' market organizations, rather than the
individual farmer, be authorized to accept cash-value vouchers, as is
permitted under the WIC Farmers' Market Nutrition Program (FMNP).
Sixty-nine commenters (mostly form letters) additionally recommended
that the WIC Program regulations be more closely aligned with the FMNP.
Commenters stated that consistency between the two programs would make
FMNP participation easier both for WIC participants and authorized
farmers. Many of the comments suggested that State agencies be allowed
to authorize farmers' markets in addition to the current provision (7
CFR 246.12(v)) that allows State agencies the flexibility to authorize
farmers at farmers' markets or roadside stands. FNS finds merit in such
a provision; this also would provide more consistency between WIC and
FMNP.
Seventy-eight comments went on to suggest that the authorization of
farmers' markets should be a Federal requirement, rather than a State
agency option. FNS believes that State agencies are in the best
position to determine what works for their individual benefit delivery
systems, taking into consideration such factors as participant access,
the availability of farmers, and the administrative burdens of
monitoring and authorization. Therefore, the final rule amends 7 CFR
246.12 to allow WIC State agencies to authorize farmers or farmers'
markets to accept WIC cash-value vouchers, but such authorization will
remain as a State agency option. As a result of the addition of
farmers' markets, conforming amendments have been

[[Page 12279]]

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

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

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

[[Page 12280]]

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

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

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

[[Page 12281]]

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

[[Page 12282]]

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

[[Page 12283]]

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

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

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

[[Page 12284]]

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

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

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

[[Page 12285]]

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

[[Page 12286]]

Procedural Matters

Executive Order 12866 and Executive Order 13563

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

Regulatory Impact Analysis Summary

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

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

[[Page 12287]]

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

Regulatory Flexibility Act

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

Need for and Objectives of the Final Rule

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

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

This final rule applies to WIC State agencies with respect to their
selection of foods to be included on their food lists. As a result,
vendors will be indirectly affected. The rule may have an indirect
economic affect on certain small businesses because they may have to
carry a larger variety of certain foods to be eligible for
authorization as a WIC vendor. Currently, approximately 46,000 stores
are authorized to accept WIC food instruments, some of which are small
businesses. With the high degree of State flexibility allowable under
this final rule, small vendors will be impacted differently in each
State depending upon how that State chooses to meet the new
requirements. Since neither FNS nor the State agencies regulate food
producers under the WIC Program, it is not known how many small
entities within that industry may be indirectly affected by the final
rule.
A 2011 evaluation conducted by Altarum Institute \7\ sought to
understand the impact that the WIC food package changes had on small
stores. The study demonstrated that most small WIC stores were able to
maintain their authorization with the WIC Program during the period the
food package changes were implemented. Small stores appear to have
added healthy foods to their inventory in response to the WIC food
package changes. The report concludes that adequate vendor preparation
likely factored into the overall success of implementation, and cites
the need for ongoing engagement of these and other WIC stakeholders.
---------------------------------------------------------------------------

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

Description of Projected Reporting, Recordkeeping, and Other Compliance
Requirements

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

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

FNS considered significant alternatives in developing the interim
rule including those that may reduce the indirect impact on small
business. These considerations included (among others) the
establishment of differing compliance or reporting requirements or
timetables that take into account the resources available to small
entities; the clarification, consolidation, or simplification of
compliance and reporting requirements under the rule for small
entities; the use of performance, rather than design, standards; and an
exemption from coverage of the rule, or any part thereof, for small
entities.
In general, the alternatives of exempting small entities from the
requirements in the interim rule or altering the requirements for small
entities were rejected. The WIC food packages provide supplemental
foods designed to address the nutritional needs of low-income pregnant,
breastfeeding, non-breastfeeding postpartum women, infants and

[[Page 12288]]

children up to age 5 who are at nutritional risk. Exempting small
entities from providing the specific foods intended to address the
nutritional needs of participants or altering the requirements for
small entities would undermine the purpose of the WIC Program and
endanger the health status of participants. Therefore, this final rule
retains those requirements.
FNS did, however, modify the new food provisions in an effort to
mitigate the impact on small entities. As in the past, State agencies
must establish minimum requirements for the variety and quantity of
foods that a vendor must stock in order to receive WIC Program
authorization. The interim rule added new food items, such as fruits
and vegetables and whole grain breads, which may require some WIC
vendors, particularly smaller stores, to expand the types and
quantities of food items stocked in order to maintain their WIC
authorization. In addition, vendors also have to make available more
than one food type from each WIC food category, except for the
categories of peanut butter and eggs, which may be a change for some
vendors. To mitigate the impact of the fruit and vegetable requirement,
the interim rule allowed canned, frozen and dried fruits and vegetables
to be substituted for fresh produce. These provisions are all retained
in this final rule.
The interim rule authorized State agencies the option to allow
participants to pay the difference if the fruit and vegetable purchase
exceeds the value of the cash-value voucher, a transaction known as
``split tender.'' In response to public comments received on the
interim rule, this final rule requires State agencies to allow split
tender transactions with the cash-value voucher.

Unfunded Mandates Reform Act

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

Executive Order 12372

The WIC Program is listed in the Catalog of Federal Domestic
Assistance Programs under 10.557. For the reasons set forth in the
final rule in 7 CFR part 3015, subpart V, and related Notice (48 FR
29115, June 24, 1983), this program is included in the scope of
Executive Order 12372 which requires intergovernmental consultation
with State and local officials.

Federalism Summary Impact Statement

Executive Order 13132 requires Federal agencies to consider the
impact of their regulatory actions on State and local governments.
Where such actions have federalism implications, agencies are directed
to provide a statement for inclusion in the preamble to the regulations
describing the agency's considerations in terms of the three categories
called for under Section (6)(b)(2)(B) of Executive Order 13121.

Prior Consultation With State Officials

Since publication of the interim rule revising the WIC food
packages, FNS has obtained input from WIC State and local agency staff
about the provisions and implementation of the changes. Examples of the
different forums and methods FNS has used to solicit WIC State and
local agency staff input on the WIC food packages include the
following:
Hosting annual meetings of the National Advisory Council
on Maternal, Infant and Fetal Nutrition that includes WIC staff as
members of the Council; the Council develops recommendations for FNS on
how to improve operations of WIC, including aspects related to the
authorized foods and food packages;
Consulting and collaborating with the National WIC
Association (NWA) on a wide variety of WIC issues, including those
related to the WIC food packages. NWA is a non-profit organization that
was founded in 1983 by State and local agencies that administer the WIC
Program. NWA's paid membership includes 72 of the 90 WIC State
agencies, 813 local agencies, 7 State WIC Associations, and 27
sustaining members (i.e., for-profit and non-profit businesses or
organizations). Functioning as a coalition of WIC agencies, NWA is
dedicated to maximizing WIC resources through effective management
practices. NWA also serves in a leadership role for WIC agencies by
developing position papers on issues of concern to the WIC community;
and
Regular meetings and consultation with State health
officials and other WIC stakeholders, including the medical community,
advocacy groups, and retailers.

Nature of Concerns and the Need To Issue This Rule

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

Extent to Which We Meet Those Concerns

FNS has considered the impact of final rule on State and local
agencies. FNS believes that the rule is responsive to the expressed
concerns and requests of commenters representing State and local
concerns.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This final rule is not intended to have
preemptive effect with respect to any State or local laws, regulations
or policies which conflict with its provisions or which would otherwise
impede its full and timely implementation. This rule is not intended to
have retroactive effect unless so specified in the DATES section of the
final rule. Prior to any judicial challenge to the provisions of the
final rule, all applicable administrative procedures must be exhausted.

Civil Rights Impact Analysis

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

[[Page 12289]]

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

Executive Order 13175

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

Paperwork Reduction Act of 1995

The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR
1320) requires that the Office of Management and Budget (OMB) approve
all collections of information by a Federal agency before they can be
implemented. Respondents are not required to respond to any collection
of information unless it displays a current valid OMB control number.
This final rule changes the information collection burden previously
approved under OMB 0584-0545. Implementation of the data collection
requirements resulting from this final rule is contingent upon OMB
approval under the Paperwork Reduction Act of 1995.
The proposed food package rule was published in the Federal
Register [71 FR 44784] with a 60-day notice on August 7, 2006, which
provided the public an opportunity to submit comments on the
information collection burden resulting from the proposed rule. FNS
received no public comments in response to this solicitation. On
November 1, 2006, OMB filed comment in accordance with 5 CFR
1320.11(c), requiring FNS to review public comments in response to the
proposed rule and address any such comments in the preamble of the
final rule.
The interim food package rule was published in the Federal Register
[72 FR 68966] on December 6, 2007, and included an estimated annual
information collection burden of 14,919 burden hours, which was
approved as OMB Number 0584-0545. These information collection burden
hours were merged into the information collection, WIC Program
Reporting and Recordkeeping Requirements, OMB Number 0584-0043,
changing the total approved burden hours for OMB Number 0584-0043 from
3,595,075 to 3,609,994. Information collection OMB Number 0584-0545 was
then discontinued. Information collection OMB Number 0584-0043 was
renewed as of December 27, 2012, changing the total approved burden
hours from 3,609,994 to 4,024,697.
In this final rule, FNS will no longer require a health care
professional licensed to write medical prescriptions to provide
documentation for children to receive soy-based beverage and tofu as
milk substitutes. Also, FNS will no longer require documentation from a
health care professional licensed to write medical prescriptions for
women to receive tofu in excess of the maximum substitution allowance.
As a result of this final rulemaking, the overall information
collection burden associated with OMB Number 0584-0043 is estimated to
have decreased by 4,200 burden hours annually due to program changes in
this rulemaking. The total estimated burden hours for OMB Number 0584-
0043 will decrease from 4,024,697 to 4,020,497.
The breakdown of the changes is described below:
OMB Number 0584-0043;
WIC Program Reporting and Recordkeeping Requirements; expiration
date December 31, 2015.
Type of Request: Revision of a currently approved collection.
Abstract: Federal regulations at 7 CFR 246.10(d)(1)(vi) and (viii)
require medical documentation for the issuance of soy-based beverage
and tofu for children, and tofu above the maximum substitution amount
for women. Federal regulations at 7 CFR 246.10(d)(1)(v) require medical
documentation for the issuance of supplemental foods to participants
who receive Food Package III (for participants with qualifying
conditions).
Under the interim rule, medical documentation by a health care
professional licensed to write medical prescriptions is required for
the issuance of certain milk alternatives for children and women. A
total of 180 comment letters (53 of these form letters) opposed this
requirement, primarily the documentation for children to receive soy-
based beverage. Commenters stated that the provision is unnecessary,
costly and burdensome for participants and physicians, creates barriers
to services, and undermines FNS' efforts to provide foods that meet the
cultural needs of participants. The NWA and the American Dietetic
Association (now known as the Academy of Nutrition and Dietetics)
stressed that WIC dietitians and nutritionists are health professionals
trained and capable of doing a complete nutrition assessment, selecting
WIC foods, and providing appropriate education to participants and
caregivers, in consultation with the health care provider when
warranted.
Based on the experiences cited by WIC State and local agencies
related to medical documentation throughout implementation of the new
food packages, FNS will no longer require a health care professional
licensed to write medical prescriptions to provide documentation for
children to receive soy-based beverage and tofu as milk substitutes.
Also, FNS will no longer require documentation from a health care
professional licensed to write medical prescriptions for women to
receive tofu in excess of the maximum substitution allowance.

Estimate of Burden

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

[[Page 12290]]

246.10(d)(1) However, medical documentation continues to be required
for issuance of supplemental foods in Food Package III. After revising
to reflect the changes made by this final rule, the total annual
reporting and recordkeeping burden estimated for medical documentation
is decreased by 4,200 hours.
FNS estimates that approximately 1 percent of participants (89,606)
will be issued supplemental foods under Food Package III. FNS estimates
that it will take three minutes (0.05 hours) for the documentation
required to issue the authorized foods, thus resulting in an estimated
reporting burden for participants of 8,961 hours (89,606 total
participants x 0.05 person hours x 2 certification periods per year).
This results in a decrease in the approved reporting burden under OMB
0584-0043 for participants providing medical documentation for
supplemental foods from 13,160 burden hours to 8,961 burden hours (a
decrease of 4,200 burden hours).
FNS will submit an Information Collection Request clearance package
to OMB based on the provisions of this final rule. These amended
information collection requirements will not become effective until
approved by OMB. When OMB has approved these information collection
requirements, FNS will publish separate action in the Federal Register
announcing OMB approval.

E-Government Act Compliance

The Food and Nutrition Service is committed to complying with the
E-Government Act, 2002, to promote the use of the Internet and other
information technologies to provide increased opportunities for citizen
access to Government information and services, and for other purposes.

List of Subjects in 7 CFR Part 246

Administrative practice and procedure, Civil rights, Food
assistance programs, Grant programs-health, Grant programs-social
programs, Indians, Infants and children, Maternal and child health,
Nutrition, Penalties, Reporting and recordkeeping requirements, Women.

0
For reasons set forth in the preamble, 7 CFR Part 246 is amended as
follows:

PART 246--SPECIAL SUPPLEMENTAL NUTRTION PROGRAM FOR WOMEN, INFANTS
AND CHILDREN

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

Authority: 42 U.S.C. 1786.

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

Sec. 246.2 Definitions.

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

Sec. 246.4 State plan.

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

[[Page 12291]]

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

Sec. 246.10 Supplemental foods.

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

[[Page 12292]]

(v) Authorized categories of supplemental foods. The supplemental
foods authorized in this food package require medical documentation for
issuance and include WIC formula (infant formula, exempt infant
formula, and WIC-eligible nutritionals), infant cereal, infant foods,
milk, cheese, eggs, canned fish, fresh fruits and vegetables, breakfast
cereal, whole wheat/whole grain bread, juice, legumes and/or peanut
butter. The maximum monthly allowances, allowed options and
substitution rates of supplemental foods for infants in Food Package
III are stated in Table 1 of paragraph (e)(9) of this section. The
maximum monthly allowances, allowed options, and substitution rates of
supplemental foods for children and women in Food Package III are
stated in Table 3 of paragraph (e)(11) of this section.
* * * * *
(4) * * *
(ii) Authorized categories of supplemental foods. Milk, breakfast
cereal, juice, fresh fruits and vegetables, whole wheat/whole grain
bread, eggs, and legumes or peanut butter are the categories of
supplemental foods authorized in this food package. The maximum monthly
allowances, allowed options and substitution rates of supplemental
foods for children in Food Package IV are stated in Table 2 of
paragraph (e)(10) of this section.
(5) Food Package V--Pregnant and partially (mostly) breastfeeding
women.--(i) Participant category served. This food package is designed
for issuance to women participants with singleton pregnancies who do
not have a condition qualifying them to receive Food Package III. This
food package is also designed for issuance to partially (mostly)
breastfeeding women participants, up to 1 year postpartum, who do not
have a condition qualifying them to receive Food Package III and whose
partially (mostly) breastfed infants receive formula from the WIC
program in amounts that do not exceed the maximum allowances described
in Table 1 of paragraph (e)(9) of this section. Women participants
partially (mostly) breastfeeding more than one infant from the same
pregnancy, pregnant women fully or partially breastfeeding singleton
infants, and women participants pregnant with two or more fetuses, are
eligible to receive Food Package VII as described in paragraph (e)(7)
of this section.
(ii) Authorized categories of supplemental foods. Milk, breakfast
cereal, juice, fresh fruits and vegetables, whole wheat/whole grain
bread, eggs, legumes and peanut butter are the categories of
supplemental foods authorized in this food package. The maximum monthly
allowances, allowed options and substitution rates of supplemental
foods for women in Food Package V are stated in Table 2 of paragraph
(e)(10) of this section.
(6) Food Package VI--Postpartum women.--(i) Participant category
served. This food package is designed for issuance to women up to 6
months postpartum who are not breastfeeding their infants, and to
breastfeeding women up to 6 months postpartum whose participating
infant receives more than the maximum amount of formula allowed for
partially (mostly) breastfed infants as described in Table 1 of
paragraph (e)(9) of this section, and who do not have a condition
qualifying them to receive Food Package III.
(ii) Authorized categories of supplemental foods. Milk, breakfast
cereal, juice, fresh fruits and vegetables, eggs, and legumes or peanut
butter are the categories of supplemental foods authorized in this food
package. The maximum monthly allowances, allowed options and
substitution rates of supplemental foods for women in Food Package VI
are stated in Table 2 of paragraph (e)(10) of this section.
(7) Food Package VII--Fully breastfeeding.--(i) Participant
category served. This food package is designed for issuance to
breastfeeding women up to 1 year postpartum whose infants do not
receive infant formula from WIC (these breastfeeding women are assumed
to be exclusively breastfeeding their infants), and who do not have a
condition qualifying them to receive Food Package III. This food
package is also designed for issuance to women participants pregnant
with two or more fetuses, women participants partially (mostly)
breastfeeding multiple infants from the same pregnancy, and pregnant
women who are also partially (mostly) breastfeeding singleton infants,
and who do not have a condition qualifying them to receive Food Package
III. Women participants fully breastfeeding multiple infants from the
same pregnancy receive 1.5 times the supplemental foods provided in
Food Package VII.
(ii) Authorized categories of supplemental foods. Milk, cheese,
breakfast cereal, juice, fresh fruits and vegetables, whole wheat/whole
grain bread, eggs, legumes, peanut butter, and canned fish are the
categories of supplemental foods authorized in this food package. The
maximum monthly allowances, allowed options and substitution rates of
supplemental foods for women in Food Package VII are stated in Table 2
of paragraph (e)(10) of this section.
* * * * *
(9) Full nutrition benefit and maximum monthly allowances, options
and substitution rates of supplemental foods for infants in Food
Packages I, II and III are stated in Table 1 as follows:

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

[[Page 12293]]

B: FNB=884 fl oz,
MMA=896 fl oz,
reconstituted
liquid
concentrate or
913 fl oz RTF or
960 fl oz
reconstituted
powder.
C: FNB=442 fl oz,
MMA=460 fl oz,
reconstituted
liquid
concentrate or
474 fl oz RTF or
522 fl oz
reconstituted
powder.
Infant Cereal 9 11.............. .................. 24 oz............. .................. 24 oz............. .................. 24 oz.
Infant food fruits and .................. 128 oz............ .................. 128 oz............ .................. 256 oz.
vegetables 9 10 11 12 13.
Infant food meat \9\............ .................. .................. .................. .................. .................. 77.5 oz.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 1 footnotes: (Abbreviations in order of appearance in table): FF = fully formula fed; BF/FF = partially (mostly) breastfed; BF = fully breastfed;
RTF = Ready-to-feed; N/A = the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. The competent
professional authority (CPA) is authorized to determine nutritional risk and prescribe supplemental foods as established by State agency policy in
Food Packages I and II. In Food Package III, the CPA, as established by State agency policy, is authorized to determine nutritional risk and prescribe
supplemental foods per medical documentation.
\2\ State agencies have the option to issue not more than one can of powder infant formula in the container size that provides closest to 104
reconstituted fluid ounces to breastfed infants on a case-by-case basis.
\3\ Liquid concentrate and ready-to-feed (RTF) may be substituted at rates that provide comparable nutritive value.
\4\ WIC formula means infant formula, exempt infant formula, or WIC-eligible nutritionals. Infant formula may be issued for infants in Food Packages I,
II and III. Medical documentation is required for issuance of infant formula, exempt infant formula, WIC-eligible nutritionals, and other supplemental
foods in Food Package III. Only infant formula may be issued for infants in Food Packages I and II.
\5\ The full nutrition benefit is defined as the minimum amount of reconstituted fluid ounces of liquid concentrate infant formula as specified for each
infant food package category and feeding variation (e.g., Food Package IA-fully formula fed).
\6\ The maximum monthly allowance is specified in reconstituted fluid ounces for liquid concentrate, RTF liquid, and powder forms of infant formula and
exempt infant formula. Reconstituted fluid ounce is the form prepared for consumption as directed on the container.
\7\ State agencies must provide at least the full nutrition benefit authorized to non-breastfed infants up to the maximum monthly allowance for the
physical form of the product specified for each food package category. State agencies must issue whole containers that are all the same size of the
same physical form. Infant formula amounts for breastfed infants, even those in the fully formula fed category should be individually tailored to the
amounts that meet their nutritional needs.
\8\ State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the
full nutrition benefit. State agencies must use the methodology described in accordance with paragraph (h)(1) of this section.
\9\ State agencies may round up and disperse whole containers of infant foods (infant cereal, fruits and vegetables, and meat) over the Food Package
timeframe. State agencies must use the methodology described in accordance with paragraph (h)(2) of this section.
\10\ At State agency option, for infants 6-12 months of age, fresh banana may replace up to 16 ounces of infant food fruit at a rate of 1 pound of
bananas per 8 ounces of infant food fruit. State agencies may also substitute fresh bananas at a rate of 1 banana per 4 ounces of jarred infant food
fruit, up to a maximum of 16 ounces.
\11\ In lieu of infant foods (cereal, fruit and vegetables), infants greater than 6 months of age in Food Package III may receive infant formula, exempt
infant formula or WIC-eligible nutritionals at the same maximum monthly allowance as infants ages 4 through 5 months of age of the same feeding
option.
\12\ At State agency option, infants 9 months through 11 months in Food Packages II and III may receive a cash-value voucher to purchase fresh (only)
fruits and vegetables in lieu of a portion of the infant food fruits and vegetables. Partially (mostly) breastfed infants and fully formula fed
infants may receive a $4 cash-value voucher plus 64 ounces of infant food fruits and vegetables; fully breastfeeding infants may receive a $8 cash-
value voucher plus 128 ounces of infant food fruit and vegetables.
\13\ State agencies may not categorically issue cash-value vouchers for infants 9 months through 11 months. The cash-value voucher is to be provided to
the participant only after an individual nutrition assessment, as established by State agency policy, and is optional for the participant, i.e., the
mother may choose to receive either the maximum allowance of jarred foods or a combination of jarred foods and a fruit and vegetable cash-value
voucher for her infant. State agencies must ensure that appropriate nutrition education is provided to the caregiver addressing safe food preparation,
storage techniques, and feeding practices to make certain participants are meeting their nutritional needs in a safe and effective manner.

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

[[Page 12294]]

Table 2--Maximum Monthly Allowances of Supplemental Foods for Children and Women in Food Packages IV, V, VI and
VII
----------------------------------------------------------------------------------------------------------------
Children Women
-------------------------------------------------------------------------------
Food Package V:
Pregnant and Food Package VI: Food Package VII:
Foods \1\ Food Package IV: 1 Partially (Mostly) Postpartum (up to Fully
through 4 years Breastfeeding (up 6 months Breastfeeding (up
to 1 year postpartum) \3\ to 1 year post-
postpartum) \2\ partum) 4 5
----------------------------------------------------------------------------------------------------------------
Juice, single strength \6\...... 128 fl oz......... 144 fl oz......... 96 fl oz.......... 144 fl oz.
Milk, fluid..................... 16 qt 7 8 9 10 11. 22 qt 7 8 9 10 12. 16 qt 7 8 9 10 12. 24 qt 7 8 9 10 12.
Breakfast cereal \13\........... 36 oz............. 36 oz............. 36 oz............. 36 oz.
Cheese.......................... N/A............... N/A............... N/A............... 1 lb.
Eggs............................ 1 dozen........... 1 dozen........... 1 dozen........... 2 dozen.
Fresh fruits and vegetables 14 $8.00 in cash- $10.00 in cash- $10.00 in cash- $10.00 in cash-
15. value vouchers. value vouchers. value vouchers. value vouchers.
Whole wheat or whole grain bread 2 lb.............. 1 lb.............. N/A............... 1 lb.
\16\.
Fish (canned)................... N/A............... N/A............... N/A............... 30 oz.
Legumes, dry \17\ and/or Peanut 1 lb or 18 oz..... 1 lb and 18 oz.... 1 lb or 18 oz..... 1 lb and 18 oz.
butter.
----------------------------------------------------------------------------------------------------------------
Table 2 Footnotes: N/A = the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the
supplemental foods. The competent professional authority (CPA) is authorized to determine nutritional risk and
prescribe supplemental foods as established by State agency policy.
\2\ Food Package V is issued to two categories of WIC participants: Women participants with singleton
pregnancies; breastfeeding women whose partially (mostly) breastfed infants receive formula from the WIC
Program in amounts that do not exceed the maximum formula allowances, as appropriate for the age of the infant
as described in Table 1 of paragraph (e)(9) of this section.
\3\ Food Package VI is issued to two categories of WIC participants: Non-breastfeeding postpartum women and
breastfeeding postpartum women whose infants receive more than the maximum infant formula allowances, as
appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section.
\4\ Food Package VII is issued to four categories of WIC participants: Fully breastfeeding women whose infants
do not receive formula from the WIC Program; women pregnant with two or more fetuses; women partially (mostly)
breastfeeding multiple infants from the same pregnancy; and pregnant women who are also fully or partially
(mostly) breastfeeding singleton infants.
\5\ Women fully breastfeeding multiple infants from the same pregnancy are prescribed 1.5 times the maximum
allowances.
\6\ Combinations of single-strength and concentrated juices may be issued provided that the total volume does
not exceed the maximum monthly allowance for single-strength juice.
\7\ Whole milk is the standard milk for issuance to 1-year-old children (12 through 23 months). At State agency
option, fat-reduced milks may be issued to 1-year-old children for whom overweight or obesity is a concern.
The need for fat-reduced milks for 1-year-old children must be based on an individual nutritional assessment
and consultation with the child's health care provider if necessary, as established by State agency policy.
Lowfat (1%) or nonfat milks are the standard milk for issuance to children >= 24 months of age and women.
Reduced fat (2%) milk is authorized only for participants with certain conditions, including but not limited
to, underweight and maternal weight loss during pregnancy. The need for reduced fat (2%) milk for children >=
24 months of age (Food Package IV) and women (Food Packages V-VII) must be based on an individual nutritional
assessment as established by State agency policy.
\8\ Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of
fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate
to fluid milk.
\9\ For children and women, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of
milk. For children and women in Food Packages IV-VI, no more than 1 pound of cheese may be substituted. For
fully breastfeeding women in Food Package VII, no more than 2 pounds of cheese may be substituted for milk.
State agencies do not have the option to issue additional amounts of cheese beyond these maximums even with
medical documentation. (No more than a total of 4 quarts of milk may be substituted for a combination of
cheese, yogurt or tofu for children and women in Food Packages IV-VI. No more than a total of 6 quarts of milk
may be substituted for a combination of cheese, yogurt or tofu for women in Food Package VII.)
\10\ For children and women, yogurt may be substituted for fluid milk at the rate of 1 quart of yogurt per 1
quart of milk; a maximum of 1 quart of milk can be substituted. Additional amounts of yogurt are not
authorized. Whole yogurt is the standard yogurt for issuance to 1-year-old children (12 through 23 months). At
State agency option, lowfat or nonfat yogurt may be issued to 1-year-old children for whom overweight and
obesity is a concern. The need for lowfat or nonfat yogurt for 1-year-old children must be based on an
individual nutritional assessment and consultation with the child's health care provider if necessary, as
established by State agency policy. Lowfat or nonfat yogurts are the only types of yogurt authorized for
children >= 24 months of age and women. (No more than a total of 4 quarts of milk may be substituted for a
combination of cheese, yogurt or tofu for children and women in Food Packages IV-VI. No more than a total of 6
quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in Food Package VII.)
\11\ For children, issuance of tofu and soy-based beverage as substitutes for milk must be based on an
individual nutritional assessment and consultation with the participant's health care provider if necessary,
as established by State agency policy. Such determination can be made for situations that include, but are not
limited to, milk allergy, lactose intolerance, and vegan diets. Soy-based beverage may be substituted for milk
for children on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted for
milk for children at the rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of
milk may be substituted for a combination of cheese, yogurt or tofu for children in Food Package IV.)
Additional amounts of tofu may be substituted, up to the maximum allowance for fluid milk for lactose
intolerance or other reasons, as established by State agency policy.
\12\ For women, soy-based beverage may be substituted for milk on a quart for quart basis up to the total
maximum allowance of milk. Tofu may be substituted for milk at the rate of 1 pound of tofu per 1 quart of
milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or tofu
for women in Food Packages V and VI. No more than a total of 6 quarts of milk may be substituted for a
combination of cheese, yogurt or tofu for women in Food Package VII.). Additional amounts of tofu may be
substituted, up to the maximum allowances for fluid milk, for lactose intolerance or other reasons, as
established by State agency policy.
\13\ At least one-half of the total number of breakfast cereals on the State agency's authorized food list must
have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a
``whole grain food with moderate fat content'' as defined in Table 4 of paragraph (e)(12) of this section.

[[Page 12295]]

\14\ Both fresh fruits and fresh vegetables must be authorized by State agencies. Processed fruits and
vegetables, i.e., canned (shelf-stable), frozen, and/or dried fruits and vegetables may also be authorized to
offer a wider variety and choice for participants. State agencies may choose to authorize one or more of the
following processed fruits and vegetables: canned fruit, canned vegetables, frozen fruit, frozen vegetables,
dried fruit, and/or dried vegetables. The cash-value voucher may be redeemed for any eligible fruit and
vegetable (refer to Table 4 of paragraph (e)(12) of this section and its footnotes). Except as authorized in
paragraph (b)(1)(i) of this section, State agencies may not selectively choose which fruits and vegetables are
available to participants. For example, if a State agency chooses to offer dried fruits, it must authorize all
WIC-eligible dried fruits.
\15\ The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as
described in Sec. 246.16(j).
\16\ Whole wheat and/or whole grain bread must be authorized. State agencies have the option to also authorize
brown rice, bulgur, oatmeal, whole-grain barley, whole wheat macaroni products, or soft corn or whole wheat
tortillas on an equal weight basis.
\17\ Canned legumes may be substituted for dry legumes at the rate of 64 oz. (e.g., four 16-oz cans) of canned
beans for 1 pound dry beans. In Food Packages V and VII, both beans and peanut butter must be provided.
However, when individually tailoring Food Packages V or VII for nutritional reasons (e.g., food allergy,
underweight, participant preference), State agencies have the option to authorize the following substitutions:
1 pound dry and 64 oz. canned beans/peas (and no peanut butter); or 2 pounds dry or 128 oz. canned beans/peas
(and no peanut butter); or 36 oz. peanut butter (and no beans).

(11) Maximum monthly allowances of supplemental foods for children
and women with qualifying conditions in Food Package III. The maximum
monthly allowances, options and substitution rates of supplemental
foods for participants with qualifying conditions in Food Package III
are stated in Table 3 as follows:

Table 3--Maximum Monthly Allowances (MMA) of Supplemental Foods for Children and Women With Qualifying
Conditions in Food Package III
----------------------------------------------------------------------------------------------------------------
Children Women
-------------------------------------------------------------------------------
Pregnant and
Foods \1\ partially Postpartum (up to Fully
1 through 4 years breastfeeding (up 6 months breastfeeding, (up
to 1 year postpartum) \3\ to 1 year post-
postpartum) \2\ partum) 4 5
----------------------------------------------------------------------------------------------------------------
Juice, single strength \6\...... 128 fl oz......... 144 fl oz......... 96 fl oz.......... 144 fl oz.
WIC Formula 7 8................. 455 fl oz liquid 455 fl oz liquid 455 fl oz liquid 455 fl oz liquid
concentrate. concentrate. concentrate. concentrate.
Milk............................ 16 qt 9 10 11 12 22 qt 9 10 11 12 16 qt 9 10 11 12 24 qt 9 10 11 12
13. 14. 14. 14.
Breakfast cereal 15 16.......... 36 oz............. 36 oz............. 36 oz............. 36 oz.
Cheese.......................... N/A............... N/A............... N/A............... 1 lb.
Eggs............................ 1 dozen........... 1 dozen........... 1 dozen........... 2 dozen.
Fruits and vegetables 17 18 19.. $8.00 in cash- $10.00 in cash- $10.00 in cash- $10.00 in cash-
value vouchers. value vouchers. value vouchers. value vouchers.
Whole wheat or whole grain bread 2 lb.............. 1 lb.............. N/A............... 1 lb.
\20\.
Fish (canned)................... N/A............... N/A............... N/A............... 30 oz.
Legumes, dry \21\ and/or Peanut 1 lb.............. 1 lb.............. 1 lb.............. 1 lb.
butter. Or................ And............... Or................ And.
18 oz............. 18 oz............. 18 oz............. 18 oz.
----------------------------------------------------------------------------------------------------------------
Table 3 Footnotes: N/A=the supplemental food is not authorized in the corresponding food package.
\1\ Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the
supplemental foods. The competent professional authority (CPA), as established by State agency policy, is
authorized to determine nutritional risk and prescribe supplemental foods per medical documentation.
\2\ This food package is issued to two categories of WIC participants: Women participants with singleton
pregnancies and breastfeeding women whose partially (mostly) breastfed infants receive formula from the WIC
Program in amounts that do not exceed the maximum formula allowances as appropriate for the age of the infant
as described in Table 1 of paragraph (e)(9) of this section.
\3\ This food package is issued to two categories of WIC participants: Non-breastfeeding postpartum women and
breastfeeding postpartum women whose breastfed infants receive more than the maximum infant formula allowances
as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section.
\4\ This food package is issued to four categories of WIC participants: Fully breastfeeding women whose infants
do not receive formula from the WIC Program; women pregnant with two or more fetuses; women partially (mostly)
breastfeeding multiple infants from the same pregnancy, and pregnant women who are also partially (mostly)
breastfeeding singleton infants.
\5\ Women fully breastfeeding multiple infants from the same pregnancy are prescribed 1.5 times the maximum
allowances.
\6\ Combinations of single-strength and concentrated juices may be issued provided that the total volume does
not exceed the maximum monthly allowance for single-strength juice.
\7\ WIC formula means infant formula, exempt infant formula, or WIC-eligible nutritionals.
\8\ Powder and ready-to-feed may be substituted at rates that provide comparable nutritive value.
\9\ Whole milk is the standard milk for issuance to 1-year-old children (12 through 23 months). Fat-reduced
milks may be issued to 1-year old children as determined appropriate by the health care provider per medical
documentation. Lowfat (1%) or nonfat milks are the standard milks for issuance for children >= 24 months of
age and women. Whole milk or reduced fat (2%) milk may be substituted for lowfat (1%) or nonfat milk for
children = 24 months of age and women as determined appropriate by the health care provider per
medical documentation.
\10\ Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of
fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate
to fluid milk.
\11\ For children and women, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of
milk. For children and women in the pregnant, partially breastfeeding and postpartum food packages, no more
than 1 pound of cheese may be substituted. For women in the fully breastfeeding food package, no more than 2
pounds of cheese may be substituted for milk. State agencies do not have the option to issue additional
amounts of cheese beyond these maximums even with medical documentation. (No more than a total of 4 quarts of
milk may be substituted for a combination of cheese, yogurt or tofu for children and women in the pregnant,
partially breastfeeding and postpartum food packages. No more than a total of 6 quarts of milk may be
substituted for a combination of cheese, yogurt or tofu for women in the fully breastfeeding food package.)

[[Page 12296]]

\12\ For children and women, yogurt may be substituted for fluid milk at the rate of 1 quart of yogurt per 1
quart of milk; a maximum of 1 quart of milk can be substituted. Additional amounts of yogurt are not
authorized. Whole yogurt is the standard yogurt for issuance to 1-year-old children (12 through 23 months).
Lowfat or nonfat yogurt may be issued to 1-year-old children (12 months to 23 months) as determined
appropriate by the health care provider per medical documentation. Lowfat or nonfat yogurts are the standard
yogurt for issuance to children >= 24 months of age and women. Whole yogurt may be substituted for lowfat or
nonfat yogurt for children >= 24 months of age and women as determined appropriate by the health care provider
per medical documentation. (No more than a total of 4 quarts of milk may be substituted for a combination of
cheese, yogurt or tofu for children and women in the pregnant, partially breastfeeding and postpartum food
packages. No more than a total of 6 quarts of milk may be substituted for a combination of cheese, yogurt or
tofu for women in the fully breastfeeding food package.)
\13\ For children, soy-based beverage and tofu may be substituted for milk as determined appropriate by the
health care provider per medical documentation. Soy-based beverage may be substituted for milk on a quart for
quart basis up to the total maximum allowance of milk. Tofu may be substituted for milk for children at the
rate of 1 pound of tofu per 1 quart of milk. (No more than a total of 4 quarts of milk may be substituted for
a combination of cheese, yogurt or tofu for children.) Additional amounts of tofu may be substituted, up to
the maximum allowance for fluid milk for children, as determined appropriate by the health care provider per
medical documentation.
\14\ For women, soy-based beverage may be substituted for milk on a quart for quart basis up to the total
maximum monthly allowance of milk. Tofu may be substituted for milk at the rate of 1 pound of tofu per 1 quart
of milk. (No more than a total of 4 quarts of milk may be substituted for a combination of cheese, yogurt or
tofu for women in the pregnant, partially breastfeeding and postpartum food packages. No more than a total of
6 quarts of milk may be substituted for a combination of cheese, yogurt or tofu for women in the fully
breastfeeding food package.) Additional amounts of tofu may be substituted, up to the maximum allowances for
fluid milk, as determined appropriate by the health care provider per medical documentation.
\15\ 32 dry ounces of infant cereal may be substituted for 36 ounces of breakfast cereal as determined
appropriate by the health care provider per medical documentation.
\16\ At least one half of the total number of breakfast cereals on the State agency's authorized food list must
have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a
``whole grain food with moderate fat content'' as defined in Table 4 of paragraph (e)(12) of this section.
\17\ Both fresh fruits and fresh vegetables must be authorized by State agencies. Processed fruits and
vegetables, i.e., canned (shelf-stable), frozen, and/or dried fruits and vegetables may also be authorized to
offer a wider variety and choice for participants. State agencies may choose to authorize one or more of the
following processed fruits and vegetables: canned fruit, canned vegetables, frozen fruit, frozen vegetables,
dried fruit, and/or dried vegetables. The cash-value voucher may be redeemed for any eligible fruit and
vegetable (refer to Table 4 of paragraph (e)(12) of this section and its footnotes). Except as authorized in
paragraph (b)(1)(i) of this section, State agencies may not selectively choose which fruits and vegetables are
available to participants. For example, if a State agency chooses to offer dried fruits, it must authorize all
WIC-eligible dried fruits.
\18\ Children and women whose special dietary needs require the use of pureed foods may receive commercial
jarred infant food fruits and vegetables in lieu of the cash-value voucher. Children may receive 128 oz of
commercial jarred infant food fruits and vegetables and women may receive 160 oz of commercial jarred infant
food fruits and vegetables in lieu of the cash-value voucher. Infant food fruits and vegetables may be
substituted for the cash-value voucher as determined appropriate by the health care provider per medical
documentation.
\19\ The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as
described in Sec. 246.16(j).
\20\ Whole wheat and/or whole grain bread must be authorized. State agencies have the option to also authorize
brown rice, bulgur, oatmeal, whole-grain barley, whole wheat macaroni products, or soft corn or whole wheat
tortillas on an equal weight basis.
\21\ Canned legumes may be substituted for dry legumes at the rate of 64 oz. (e.g., four 16-oz cans) of canned
beans for 1 pound dry beans. In Food Packages V and VII, both beans and peanut butter must be provided.
However, when individually tailoring Food Packages V or VII for nutritional reasons (e.g., food allergy,
underweight, participant preference), State agencies have the option to authorize the following substitutions:
1 pound dry and 64 oz. canned beans/peas (and no peanut butter); or 2 pounds dry or 128 oz. canned beans/peas
(and no peanut butter); or 36 oz. peanut butter (and no beans).

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

Table 4--Minimum Requirements and Specifications for Supplemental Foods
------------------------------------------------------------------------
Categories/foods Minimum requirements and specifications
------------------------------------------------------------------------
WIC FORMULA:
Infant formula........... All authorized infant formulas must:
(1) Meet the definition for an infant
formula in section 201(z) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
321(z)) and meet the requirements for an
infant formula under section 412 of the
Federal Food, Drug and Cosmetic Act, as
amended (21 U.S.C. 350a) and the
regulations at 21 CFR parts 106 and 107;
(2) Be designed for enteral digestion via
an oral or tube feeding;
(3) Provide at least 10 mg iron per liter
(at least 1.5 mg iron/100 kilocalories)
at standard dilution;
(4) Provide at least 67 kilocalories per
100 milliliters (approximately 20
kilocalories per fluid ounce) at
standard dilution.
(5) Not require the addition of any
ingredients other than water prior to
being served in a liquid state.
Exempt infant formula.... All authorized exempt infant formula
must:
(1) Meet the definition and requirements
for an exempt infant formula under
section 412(h) of the Federal Food,
Drug, and Cosmetic Act as amended (21
U.S.C. 350a(h)) and the regulations at
21 CFR parts 106 and 107; and
(2) Be designed for enteral digestion via
an oral or tube feeding.
WIC-eligible Certain enteral products that are
nutritionals.\1\. specifically formulated to provide
nutritional support for individuals with
a qualifying condition, when the use of
conventional foods is precluded,
restricted, or inadequate. Such WIC-
eligible nutritionals must serve the
purpose of a food, meal or diet (may be
nutritionally complete or incomplete)
and provide a source of calories and one
or more nutrients; be designed for
enteral digestion via an oral or tube
feeding; and may not be a conventional
food, drug, flavoring, or enzyme.

MILK AND MILK ALTERNATIVES:

[[Page 12297]]

Cow's milk \2\............. Must conform to FDA standard of identity
for whole, reduced fat, lowfat, or
nonfat milks (21 CFR 131.110). Must be
pasteurized. May be flavored or
unflavored. May be fluid, shelf-stable,
evaporated (21 CFR 131.130), or dry.
Dry whole milk must conform to FDA
standard of identity (21 CFR 131.147).
Nonfat dry milk must conform to FDA
standard of identity (21 CFR 131.127).
Cultured milks must conform to FDA
standard of identity for cultured milk,
e.g. cultured buttermilk, kefir cultured
milk, acidophilus cultured milk (21 CFR
131.112).
Acidified milk must conform to FDA
standard of identity for acidified milk,
e.g., acidified kefir milk, acidified
acidophilus milk or acidified buttermilk
(21 CFR 131.111).
All reduced fat, lowfat, and nonfat cow's
milk types and varieties must contain at
least 400 IU of vitamin D per quart (100
IU per cup) and 2000 IU of vitamin A per
quart (500 IU per cup).
Goat's milk.................. Must be pasteurized. May be flavored or
unflavored. May be fluid, shelf-stable,
evaporated or dry (i.e., powdered).
All reduced fat, lowfat, and nonfat
goat's milk must contain at least 400 IU
of vitamin D per quart (100 IU per cup)
and 2000 IU of vitamin A per quart (500
IU per cup).
Cheese....................... Domestic cheese made from 100 percent
pasteurized milk. Must conform to FDA
standard of identity (21 CFR part 133);
Monterey Jack, Colby, natural Cheddar,
Swiss, Brick, Muenster, Provolone, part-
skim or whole Mozzarella, pasteurized
process American, or blends of any of
these cheeses are authorized.
Cheeses that are labeled low, free,
reduced, less or light in sodium, fat or
cholesterol are WIC eligible.
Yogurt (cow's milk).......... Yogurt must be pasteurized and conform to
FDA standard of identity for whole fat
(21 CFR 131.200), lowfat (21 CFR
131.203), or nonfat (21 CFR 131.206);
plain or flavored with <=40 g of total
sugars per 1 cup yogurt. Yogurts that
are fortified with vitamin A and D and
other nutrients may be allowed at the
State agency's option. Yogurts sold with
accompanying mix-in ingredients such as
granola, candy pieces, honey, nuts and
similar ingredients are not authorized.
Drinkable yogurts are not authorized.
Tofu......................... Calcium-set tofu prepared with calcium
salts (e.g., calcium sulfate). May not
contain added fats, sugars, oils, or
sodium. Tofu must be calcium-set, i.e.,
contain calcium salts, but may also
contain other coagulants, i.e.,
magnesium chloride.
Soy-based beverage........... Must be fortified to meet the following
nutrient levels: 276 mg calcium per cup,
8 g protein per cup, 500 IU vitamin A
per cup, 100 IU vitamin D per cup, 24 mg
magnesium per cup, 222 mg phosphorus per
cup, 349 mg potassium per cup, 0.44 mg
riboflavin per cup, and 1.1 mcg vitamin
B12 per cup, in accordance with
fortification guidelines issued by FDA.
May be flavored or unflavored.
JUICE........................ Must be pasteurized 100% unsweetened
fruit juice. Must contain at least 30 mg
of vitamin C per 100 mL of juice. Must
conform to FDA standard of identity as
appropriate (21 CFR part 146) or
vegetable juice must conform to FDA
standard of identity as appropriate (21
CFR part 156). With the exception of
100% citrus juices, State agencies must
verify the vitamin C content of all
State-approved juices. Juices that are
fortified with other nutrients may be
allowed at the State agency's option.
Juice may be fresh, from concentrate,
frozen, canned, or shelf-stable. Blends
of authorized juices are allowed.
Vegetable juice may be regular or lower
in sodium.
EGGS......................... Fresh shell domestic hens' eggs or dried
eggs mix (must conform to FDA standard
of identity in 21 CFR 160.105) or
pasteurized liquid whole eggs (must
conform to FDA standard of identity in
21 CFR 160.115).
Hard boiled eggs, where readily available
for purchase in small quantities, may be
provided for homeless participants.
BREAKFAST CEREAL (READY-TO- Must contain a minimum of 28 mg iron per
EAT AND INSTANT AND REGULAR 100 g dry cereal.
HOT CEREALS). Must contain <=21.2 g sucrose and other
sugars per 100 g dry cereal (<=6 g per
dry oz).
At least half of the cereals authorized
on a State agency's food list must have
whole grain as the primary ingredient by
weight AND meet labeling requirements
for making a health claim as a ``whole
grain food with moderate fat
content''.\3\
FRUITS AND VEGETABLES (FRESH Any variety of fresh (as defined by 21
AND PROCESSED) 4 5 6 8 9. CFR 101.95) whole or cut fruit without
added sugars.
Any variety of fresh (as defined by 21
CFR 101.95) whole or cut vegetable,
except white potatoes, without added
sugars, fats, or oils (orange yams and
sweet potatoes are allowed).
Any variety of canned fruits (must
conform to FDA standard of identity as
appropriate (21 CFR part 145));
including applesauce, juice pack or
water pack without added sugars, fats,
oils, or salt (i.e., sodium). The fruit
must be listed as the first ingredient.
Any variety of frozen fruits without
added sugars, fats, oils, or salt (i.e.,
sodium).
Any variety of canned or frozen
vegetables, except white potatoes
(orange yams and sweet potatoes are
allowed); without added sugars, fats, or
oils. Vegetable must be listed as the
first ingredient. May be regular or
lower in sodium. Must conform to FDA
standard of identity as appropriate (21
CFR part 155).
Any type of dried fruits or dried
vegetable, except white potatoes (orange
yams and sweet potatoes are allowed);
without added sugars, fats, oils, or
salt (i.e., sodium).
Any type of immature beans, peas, or
lentils, fresh or in canned \5\ forms.
Any type of frozen beans (immature or
mature). Beans purchased with the CVV
may contain added vegetables and fruits,
but may not contain added sugars, fats,
oils, or meat as purchased. Canned
beans, peas, or lentils may be regular
or lower in sodium content.
State agencies must allow organic forms
of WIC-eligible fruits and vegetables.
WHOLE WHEAT BREAD, WHOLE
GRAIN BREAD, AND WHOLE GRAIN
OPTIONS:
Bread.................... Whole wheat bread must conform to FDA
standard of identity (21 CFR 136.180).
(Includes whole wheat buns and rolls.)
``Whole wheat flour'' and/or ``bromated
whole wheat flour'' must be the only
flours listed in the ingredient list.

[[Page 12298]]

OR
Whole grain bread must conform to FDA
standard of identity (21 CFR 136.110)
(includes whole grain buns and rolls).
AND
Whole grain must be the primary
ingredient by weight in all whole grain
bread products.
AND
Must meet FDA labeling requirements for
making a health claim as a ``whole grain
food with moderate fat content''.\3\
Whole Grain Options...... Brown rice, bulgur, oats, and whole-grain
barley without added sugars, fats, oils,
or salt (i.e., sodium). May be instant-,
quick-, or regular-cooking.
Soft corn or whole wheat tortillas. Soft
corn tortillas made from ground masa
flour (corn flour) using traditional
processing methods are WIC-eligible,
e.g., whole corn, corn (masa), whole
ground corn, corn masa flour, masa
harina, and white corn flour. For whole
wheat tortillas, ``whole wheat flour''
must be the only flour listed in the
ingredient list.
Whole wheat macaroni products. Must
conform to FDA standard of identity (21
CFR 139.138) and have no added sugars,
fats, oils, or salt (i.e., sodium).
``Whole wheat flour'' and/or ``whole
durum wheat flour'' must be the only
flours listed in the ingredient list.
Other shapes and sizes that otherwise
meet the FDA standard of identity for
whole wheat macaroni (pasta) products
(139.138), and have no added sugars,
fats, oils, or salt (i.e., sodium), are
also authorized (e.g., whole wheat
rotini, and whole wheat penne).
FISH (CANNED) \5\............ Canned only:
Light tuna (must conform to FDA standard
of identity (21 CFR 161.190));
Salmon (Pacific salmon must conform to
FDA standard of identity (21 CFR
161.170));
Sardines; and
Mackerel (N. Atlantic Scomber scombrus;
Chub Pacific Scomber japonicas; Jack
Mackerel \10\
May be packed in water or oil. Pack may
include bones or skin. Added sauces and
flavorings, e.g., tomato sauce, mustard,
lemon, are authorized at the State
agency's option. May be regular or lower
in sodium content.
MATURE LEGUMES (DRY BEANS AND Any type of mature dry beans, peas, or
PEAS) \7\. lentils in dry-packaged or canned \5\
forms. Examples include but are not
limited to black beans, black-eyed peas,
garbanzo beans (chickpeas), great
northern beans, white beans (navy and
pea beans), kidney beans, mature lima
(``butter beans''), fava and mung beans,
pinto beans, soybeans/edamame, split
peas, lentils, and refried beans. All
categories exclude soups. May not
contain added sugars, fats, oils,
vegetables, fruits or meat as purchased.
Canned legumes may be regular or lower
in sodium content.\11\
Baked beans may only be provided for
participants with limited cooking
facilities.\11\
PEANUT BUTTER................ Peanut butter and reduced fat peanut
butter (must conform to FDA Standard of
Identity (21 CFR 164.150)); creamy or
chunky, regular or reduced fat, salted
or unsalted forms are allowed. Peanut
butters with added marshmallows, honey,
jelly, chocolate or similar ingredients
are not authorized.
INFANT FOODS:
Infant Cereal............ Infant cereal must contain a minimum of
45 mg of iron per 100 g of dry
cereal.\12\
Infant Fruits............ Any variety of single ingredient
commercial infant food fruit without
added sugars, starches, or salt (i.e.,
sodium). Texture may range from strained
through diced. The fruit must be listed
as the first ingredient.\13\
Infant Vegetables........ Any variety of single ingredient
commercial infant food vegetables
without added sugars, starches, or salt
(i.e., sodium). Texture may range from
strained through diced. The vegetable
must be listed as the first
ingredient.\14\
Infant Meat.............. Any variety of commercial infant food
meat or poultry, as a single major
ingredient, with added broth or gravy.
Added sugars or salt (i.e. sodium) are
not allowed. Texture may range from
pureed through diced.\15\
------------------------------------------------------------------------
Table 4 Footnotes: FDA = Food and Drug Administration of the U.S.
Department of Health and Human Services.
\1\ The following are not considered a WIC-eligible nutritional:
Formulas used solely for the purpose of enhancing nutrient intake,
managing body weight, addressing picky eaters or used for a condition
other than a qualifying condition (e.g., vitamin pills, weight control
products, etc.); medicines or drugs, as defined by the Food, Drug and
Cosmetic Act (21 U.S.C. 350a) as amended; enzymes, herbs, or
botanicals; oral rehydration fluids or electrolyte solutions;
flavoring or thickening agents; and feeding utensils or devices (e.g.,
feeding tubes, bags, pumps) designed to administer a WIC-eligible
formula.
\2\ All authorized milks must conform to FDA standards of identity for
milks as defined by 21 CFR part 131 and meet WIC's requirements for
vitamin fortification as specified in Table 4 of paragraph (e)(12) of
this section. Additional authorized milks include, but are not limited
to: calcium-fortified, lactose-reduced and lactose-free, organic and
UHT pasteurized milks. Other milks are permitted at the State agency's
discretion provided that the State agency determines that the milk
meets the minimum requirements for authorized milk.
\3\ FDA Health Claim Notification for Whole Grain Foods with Moderate
Fat Content at https://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073634.htm
\4\ Processed refers to frozen, canned,\5\ or dried.
\5\ ``Canned'' refers to processed food items in cans or other shelf-
stable containers, e.g., jars, pouches.
\6\ The following are not authorized: herbs and spices; creamed
vegetables or vegetables with added sauces; mixed vegetables
containing noodles, nuts or sauce packets, vegetable-grain (pasta or
rice) mixtures; fruit-nut mixtures; breaded vegetables; fruits and
vegetables for purchase on salad bars; peanuts or other nuts;
ornamental and decorative fruits and vegetables such as chili peppers
on a string; garlic on a string; gourds; painted pumpkins; fruit
baskets and party vegetable trays; decorative blossoms and flowers,
and foods containing fruits such as blueberry muffins and other baked
goods. Home-canned and home-preserved fruits and vegetables are not
authorized.
\7\ Mature legumes in dry-packed or canned forms may be purchased with
the WIC food instrument only. Immature varieties of fresh or canned
beans and frozen beans of any type (immature or mature) may be
purchased with the cash-value voucher only. Juices are provided as
separate food WIC categories and are not authorized under the fruit
and vegetable category.
\8\ Excludes white potatoes, mixed vegetables containing white potatoes,
dried white potatoes; catsup or other condiments; pickled vegetables;
olives; soups; juices; and fruit leathers and fruit roll-ups. Canned
tomato sauce, tomato paste, salsa and spaghetti sauce without added
sugar, fats, or oils are authorized.
\9\ State agencies have the option to allow only lower sodium canned
vegetables for purchase with the cash-value voucher.
\10\ FDA defines jack mackerel as any of the following six species:
Trachurus declivis, trachurus japonicas, trachurur symmetricus,
trachurus murphyi, trachurus novaezelandiae, and trachurus lathami in
The Seafood List at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm113260.htm. King
mackerel is not authorized.

[[Page 12299]]

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

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

Sec. 246.12 Food delivery systems.

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

[[Page 12300]]

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

Sec. 246.16 Distribution of funds.

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

Sec. 246.18 Administrative review of State agency actions.

(a) * * *
(4) Farmer or farmers' market appeals.--(i) Adverse actions. The
State agency shall provide a hearing procedure whereby farmers or
farmers' markets adversely affected by certain actions of the State
agency may appeal those actions. A farmer or farmers' market may appeal
an action of the State agency denying its application to participate,
imposing a sanction, or disqualifying it from participation in the
program. Expiration of an agreement is not subject to appeal.
(ii) Effective date of adverse actions against farmers or farmers'
markets. The State agency must make denials of authorization and
disqualifications effective on the date of receipt of the notice of
adverse action. The State agency must make all other adverse actions
effective no earlier than 15 days after the date of the notice of the
adverse action and no later than 90 days after the date of the notice
of adverse action or, in the case of an adverse action that is subject
to administrative review, no later than the date the farmer receives
the review decision. The State agency must make all other adverse
actions effective no earlier than 15 days after the date of the notice
of adverse action and no later than 90 days after the date of the
notice of adverse action or, in the case of an adverse action that is
subject to an administrative review, no later than the date the farmer
or farmers' market receives the review decision.
(b) * * *
(9) Written notification of the review decision, including the
basis for the decision, within 90 days from the date of receipt of the
request for an administrative review from a vendor, farmer, or farmer's
market, and within 60 days from the date of receipt of a local agency's
request for an administrative review. * * *
(c) * * *
(2) A decision-maker who is someone other than the person who
rendered the initial decision on the action and whose determination is
based solely on whether the State agency has correctly applied Federal
and State statutes, regulations, policies, and procedures governing the
Program, according to the information provided to the vendor, farmer,
or farmers' market concerning the cause(s) for the adverse action and
the response from the vendor, farmer, or farmers' market.
* * * * *
0
8. In Sec. 246.23:
0
a. Amend paragraph (a)(1) by removing the words ``or food instruments''
and by adding in its place the phrase ``food instruments, or cash-value
vouchers''; and
0
b. Revise paragraph (a)(2).
The revisions read as follows:

Sec. 246.23 Claims and penalties.

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

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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.