[Federal Register: December 6, 2007 (Volume 72, Number 234)] [Rules and Regulations] [Page 68965-69032] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06de07-8] [[Page 68965]] ----------------------------------------------------------------------- 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; Interim Rule [[Page 68966]] ----------------------------------------------------------------------- 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, USDA. ACTION: Interim rule. ----------------------------------------------------------------------- SUMMARY: This interim rule revises regulations governing the WIC food packages to align the WIC food packages with the Dietary Guidelines for Americans (DGA) \1\ and current infant feeding practice guidelines of the American Academy of Pediatrics, better promote and support 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. DATES: Effective Date: This rule is effective February 4, 2008. Implementation Date: State agencies must implement the provisions of this rule no later than August 5, 2009. Comment Date: To be considered, comments on this interim rule must be postmarked on or before February 1, 2010. ADDRESSES: The Food and Nutrition Service (FNS) invites interested persons to submit comments on this interim rule. Comments may be submitted by any of the following methods: Federal eRulemaking Portal: Go to http://www.regulations.gov , select ``Food and Nutrition Service,'' from the agency drop-down menu, then click ``Submit.'' In the Docket ID column, select FNS-2006-0037 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's ``User Tips'' link. Mail: Send comments to Patricia N. Daniels, Director, Supplemental Food Programs Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 528, Alexandria, Virginia 22302, (703) 305-2746. Comments submitted in response to this interim rule will be included in the record and will be made available to the public. Please be advised that the substance of the comments and the identities of the individuals or entities submitting the comments will be subject to public disclosure. FNS will make the comments publicly available on the Internet via http://www.regulations.gov Information regarding the interim rule will be available on the FNS Web site at http://. http://www.fns.usda.gov/wic. A regulatory impact analysis has been prepared for this rule. It follows this regulation as an Appendix. FOR FURTHER INFORMATION CONTACT: Debra Whitford, Chief, Policy and Program Development Branch, Supplemental Food Programs Division, Supplemental Food Programs Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 528, Alexandria, Virginia 22302, (703) 305-2746, or Debbie.Whitford@fns.usda.gov. SUPPLEMENTARY INFORMATION: I. Overview This interim rule implements the first comprehensive revisions to the WIC food packages since 1980. These revised food packages were developed to better reflect current nutrition science and dietary recommendations than do current food packages, within the parameters of current program costs. II. Background The WIC food packages provide supplemental foods designed to address the nutritional needs of low-income pregnant, breastfeeding, non-breastfeeding postpartum women, infants and children up to five years of age who are at nutritional risk. WIC food packages and nutrition education are the chief means by which WIC affects the dietary quality and habits of participants. WIC is a unique nutrition assistance program in that it also serves as an adjunct to good health care during critical times of growth and development to prevent the occurrence of health problems and to improve the health status of Program participants. WIC was never intended to be a primary source of food, nor of general food assistance. Rather, WIC food benefits are scientifically-based and intended to address the supplemental nutritional needs of a specific population--low income pregnant, breastfeeding, non-breastfeeding postpartum women, infants and children up to five years of age who are at nutritional risk. In addition to WIC, the Food and Nutrition Service (FNS) administers a variety of other complementary nutrition assistance programs that work together to provide a more complete diet to low-income persons. Low-income families can, and frequently do, receive benefits from more than one of these programs. The largest of these programs, the Food Stamp Program, provides general food assistance intended to increase the food buying power of low-income households. The ability of the WIC food packages to reinforce nutrition education messages provided to participants is critical to affecting the dietary quality and habits of infants, children and mothers served by WIC. The nutrition education provided by WIC enables participants to make informed decisions in choosing foods that, together with the supplemental foods contained in the WIC food packages, can meet their total dietary needs. The intent is to help participants continue healthful dietary practices after leaving the Program. Since the creation of the WIC Program in the 1970s, and the last major revision of the WIC food packages in the early 1980's, much has been learned about the nutritional needs of Americans, including WIC's target population of pregnant and postpartum women, infants, and preschool aged children. In recent years the ability of the WIC Program to address the supplemental nutritional needs of WIC participants through its food packages and nutrition education has received growing attention. Significant interest in updating the food packages based on new information about the needs of low-income, culturally diverse women, infants, and children has been voiced by WIC Program administrators, the medical and scientific communities, advocacy groups, and Congress. III. General Summary of Comments Received on the Proposed Rule To Revise the WIC Food Packages The Proposed Rule to revise regulations pertaining to the supplemental foods provided through the WIC Program was published in the Federal Register on August 7, 2006 (71 FR 44784), with a 90-day comment period. The proposed rule largely reflected recommendations made by the National Academies' Institute of Medicine (IOM) in its Report ``WIC Food Packages--Time for a Change,'' \(2)\ with modifications found necessary by FNS to ensure cost neutrality. A total of 46,502 comment letters were received on the Proposed Rule; of those, 23,908 were form letters. A total of 38,257 letters were received from program participants; 18,080 of those were form letters. The remaining comment letters were submitted from a [[Page 68967]] 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, the proposed changes to the WIC food packages garnered broad support from public commenters. A total of 21,042 commenters (8,293 of these form letters) made explicit statements regarding the merits of the proposed rule as a whole. Of those, 20,438 (8,292 of which were form letters) expressed support for the majority of the proposed revisions. A total of 604 commenters (1 of these a form letter) disagreed with the majority of the proposed rule provisions-- these letters were primarily from participants who did not want to see any changes to the current WIC food packages. FNS considered all 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. IV. Discussion of the Proposed Provisions The following is a discussion of the major provisions set forth in the proposed rule, a brief summary of the comments received that addressed these issues, and FNS' rationale for either modifying each section in the interim rule, or retaining its provisions as initially proposed. Provisions not addressed in the preamble to this interim rule did not receive significant or substantial public comments and are retained in this interim rule as proposed. This preamble articulates the basis and purpose behind significant changes from the August 7, 2006, proposal. The reasons supporting provisions of the proposed regulations were carefully examined in light of the comments to determine the continued applicability of the justifications. Unless otherwise stated, or unless inconsistent with the interim rule or this preamble, the rationales contained in the preamble to the proposed regulations should be regarded as a basis for the interim rule. Therefore, a thorough understanding of the rationales for the interim regulations may require reference to the preamble of the August 7, 2006 proposal (71 FR 44784). A. Definitions 1. Participation. FNS proposed to revise the definition for WIC ``participation'' to include the number of breastfeeding women who receive no supplemental foods or food instruments but whose breastfed infant(s) receives the supplemental foods or food instruments. The definition means, therefore, that a partially breastfeeding woman who requests, after the sixth month postpartum, more than the maximum amount of formula allowed for a partially breastfed infant would no longer receive a food package but would continue to count as a WIC participant and receive other Program benefits and nutrition services (nutrition education, including breastfeeding promotion and support, and referrals to health and social services.) Thirty-two commenters (15 form letters) were opposed to not providing a food package to partially breastfeeding women who request, after the sixth month postpartum, more formula than the maximum. The IOM recommended that a partially breastfeeding woman who requests, after the sixth month postpartum, more than the maximum amount of formula for a partially breastfed infant, no longer be certified for the WIC Program. However, FNS determined that this approach is incongruous with the definition of breastfeeding in WIC regulations at 7 CFR 246.2--the practice of feeding a mother's breastmilk to her infant(s) on the average of at least once per day. In WIC, this definition is used to determine Program eligibility, and allows all breastfeeding women, regardless of feeding pattern, to participate in the WIC Program, be counted as a breastfeeding woman, and receive supplemental foods, breastfeeding promotion and support, and referrals to health care. The definition recognizes that any breastfeeding, even if only on an average of once a day, provides some immunological and nutritional benefits that would otherwise not be provided to an infant. Rather than adopt IOM's recommendation in its entirety, FNS proposed to revise the definition for WIC ``participation'' to include breastfeeding women who receive no supplemental foods or food instruments but whose breastfed infant(s) receives supplemental food or food instruments. Counting these women, although they are not receiving a food package, is consistent with the current practice of counting the infants of exclusively breastfeeding women. Therefore, a partially breastfeeding woman who requests, after the sixth month postpartum, more than the maximum amount of formula allowed for a partially breastfed infant would no longer receive a food package but would continue to count as a WIC participant and receive other Program benefits (nutrition education, including breastfeeding promotion and support, and referrals to health and social services). This would serve to meet the intent of IOM's recommendations within the context of WIC regulations. As recommended by some commenters, FNS clarifies that breastfeeding women who receive no supplemental foods or food instruments but whose breastfed infant(s) receives the supplemental foods or food instruments continue to be eligible to receive nutrition services, and breast pumps are a part of nutrition services. With this clarification, the definition of participation is retained in this interim rule as proposed at 7 CFR 246.2. 2. WIC-eligible medical foods. FNS proposed to revise the definition for ``WIC-eligible medical foods'' to clarify that medical foods are designed for children 12 months and older and adults and that WIC-eligible medical foods are not conventional foods, drugs, flavorings or enzymes. A few commenters disagreed with the proposed definition for WIC-eligible medical foods stating that the definition as proposed would exclude infants from receiving certain medical foods that are appropriate for them such as modular formulas that are not nutritionally complete but add specific nutrients such as protein, fat, and carbohydrate. FNS acknowledges that certain medical foods exist that are appropriate for use by infants and that medically fragile infants should be included as a participant category in the WIC- eligible medical food definition. Several other commenters believe that FNS should rely on Food and Drug Administration (FDA) expertise for the definition of medical foods since FDA is the regulatory authority for medical foods. FNS acknowledges FDA's role in the regulation of medical foods. However, specific requirements for the safety or appropriate use of medical foods have not yet been established by FDA. FNS agrees with commenter concerns that the proposed definition for WIC-eligible medical foods excludes infants as a participant category. Therefore, the proposed definition for WIC-eligible medical foods is revised in this interim rule to include infants as a participant category. [[Page 68968]] B. General Provisions That Affect All WIC Food Packages 1. Food Lists The proposed rule would have continued to require State agencies to identify brands and package sizes that are acceptable for use in their States from among those authorized and to provide to local agencies a list of acceptable foods and their maximum monthly allowances in accordance with WIC requirements. This provision is retained in this interim rule at 7 CFR 246.10(b)(2)(i). A conforming amendment in this interim rule at 7 CFR 246.4 clarifies that a copy of the food list must be included in the State Plan. 2. Nutrition Tailoring Current FNS policy allows 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 and State established policies. The proposed rule would have prohibited categorical nutrition tailoring, but continue to allow individual nutrition tailoring based on the Competent Professional Authority's assessment of a participant's supplemental nutrition needs. A total of 528 commenters (of these, 505 were form letters) agreed with the proposal to eliminate State authority to categorically tailor food packages, stating that the careful balance achieved by the IOM's recommendations to revise the WIC food packages should be maintained. In contrast, 187 commenters (of these, 151 were form letters) were opposed to the provision, stating that States need the flexibility to propose modifications to food packages that respond to rapid changes in food industry, science, demographics, and other factors. As discussed at length in the preamble to the proposed rule, the revised food packages have the potential to address current nutrient inadequacies and excesses; discrepancies between dietary intake and dietary guidance; and current and future health-related problems in WIC's target population. The IOM was also charged with considering the cultural needs of WIC participants and its recommendations for revisions to the WIC food packages, and the proposed rule, reflect those considerations. The IOM had the resources and capacity to conduct an independent, rigorous scientific review of the nutritional needs of WIC participants in each category prior to recommending the quantities and types of WIC foods to address those needs in its Report.\(2)\ Because the IOM based the revisions to the WIC food packages on current nutrition science, FNS proposed that State agencies would no longer be authorized to categorically tailor food packages. FNS believes 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 interim rule at 7 CFR 246.10(c). FNS clarifies that, in addition to having the authority to individually tailor food packages, State agencies continue to have the authority to make adjustments to WIC foods for administrative convenience and to control costs. Such adjustments may involve packaging methods, container sizes, brands, types and physical forms of WIC foods. 3. Cultural Food Package Proposals A total of 174 commenters (of these, 149 were form letters) were opposed to FNS' proposal to no longer consider WIC State agency requests for cultural food substitutions. Commenters cited the need for State agencies to have the flexibility to keep pace with demographic changes in the WIC population. FNS believes that the increased variety and choice in the supplemental foods in this interim rule provide State agencies expanded flexibility in prescribing culturally appropriate packages for diverse groups. Section 203(c) of Public Law 108-265 amended Section 17(c)(2) of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by requiring the Secretary to conduct, as often as necessary, 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 used to determine the need for additional cultural accommodations. However, in response to requests by commenters to allow State agencies the flexibility to meet unanticipated cultural needs of participants, a new 7 CFR 246.10(i) has been added to this interim rule that allows State agencies to submit to FNS a plan for substitution of food(s) to allow for different cultural eating patterns. The criteria for submitting plans for substitutions for different cultural eating patterns and the criteria FNS will use to evaluate such plans are the same as those under current WIC regulations at 7 CFR 246.10(e). 4. Medical Documentation and Supervision Requirements Under the proposed rule, medical documentation would have been required for certain milk alternatives for children and women and for any supplemental foods authorized in proposed Food Package III. Under the proposed rule, medical documentation would continue to be required for any contract brand infant formula that does not meet the requirements of an infant formula as specified in Table 4 of 7 CFR 246.10(e)(12) of the proposed rule, any non-contract brand infant formula, any exempt infant formula, or any WIC-eligible medical food. Under current WIC regulations, the technical requirements for medical documentation include: Brand name of the WIC formula prescribed; Medical diagnosis warranting the WIC formula; Length of time the prescribed WIC formula is medically required by the participant; and Signature (or name, if the initial documentation was received by telephone) of the requesting health care provider. Under the proposed rule, additional technical requirements would have been added as follows: Contact information for the participant's healthcare provider making the medical determination; Date of medical determination; Name of specific supplemental food(s) to be prescribed; Amount prescribed per day of WIC formula and/or supplemental foods; Qualifying condition that warrants the issuance of the specific supplemental food(s); and Length of time the specific supplemental food(s) is medically required. A total of 2,107 comment letters (1,945 of these were form letters) opposed the proposed medical documentation, primarily the documentation for children to receive soy-based beverage. Commenter's stated that the medical documentation requirement for soy-based beverage for children would create barriers to services and undermine FNS' efforts to provide foods that meet the cultural needs of participants. A small number of comments received from WIC staff primarily at the local level expressed concern that requiring medical documentation for the additional supplemental foods allowed in proposed Food Package III and requiring [[Page 68969]] a prescribed amount per day is burdensome to participants, the medical community and WIC agencies. FNS understands the potential administrative impact of requiring medical documentation for the provision of supplemental foods in Food Package III. However, these medical documentation requirements were proposed to ensure that the participant's healthcare provider, licensed in the State to write prescriptions, has determined that the supplemental foods are not medically contraindicated by the participant's qualifying condition. Participants that receive Food Package III are medically fragile and should be under the care of a healthcare professional for the purpose of close medical supervision essential for the participant's overall dietary management. Participants that receive Food Package III have qualifying medical conditions that preclude or restrict their use of conventional foods. Requiring medical documentation to include the additional supplemental foods allowed in proposed Food Package III and requiring an amount prescribed per day will ensure that the participant's health care provider is aware that WIC is providing supplemental foods that the health care provider has determined are not medically contraindicated by the participant's qualifying medical condition. Requiring the health care provider to designate an amount of WIC formula and the WIC supplemental foods allowed in the participant's diet will help the Certified Professional Authority (CPA) in designing nutrition education and a food package prescription that is appropriate to the participant's medical needs. FNS acknowledges that some additional administrative tasks will occur because of medical documentation requirements for dairy alternatives. However, requiring medical documentation for soy-based beverage for children ensures that a child's health care provider is aware that the child may be at nutritional risk when milk is replaced by other foods. The DGA \(1)\ stress the importance of milk consumption in the development of bone mass for children. The IOM noted that while soy products may be an appropriate choice for children who cannot consume milk, soy should not be made available to satisfy participant preference in the absence of medical need. Therefore, the proposed provisions for medical documentation for certain milk alternatives for children and women and for any supplemental foods authorized in proposed Food Package III are retained in this interim rule at 7 CFR 246.10(d). Proposed provisions related to revised medical documentation requirements that are not addressed in this preamble did not receive significant or substantial public comments and are retained in this interim rule as proposed. 5. Organic Foods A number of commenters asked FNS to allow organic products within the authorized categories of foods in the WIC food packages. FNS points out that some organic forms of WIC-eligible foods meet the nutritional requirements set forth in current WIC regulations and are therefore authorized; this interim rule continues to authorize 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 brands and types of foods to authorize on their State WIC food lists. Some State agencies may 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. C. Supplemental Foods and Food Packages Note: In the interest of clarity, specific food package issues are discussed according to food item rather than food package and then the food package categories are discussed. The order of some of the topics in this section is modified from the proposed rule for the purposes of discussion. 1. Fruits and Vegetables in Food Packages III Through VII The addition of fruits and vegetables to the WIC food packages was the most welcomed provision of the proposed rule across all commenter categories. Of the total of 40,026 comment letters that addressed fruits and vegetables, 39,961 (22,935 of these form letters) were favorable. The majority of the few opposing comments were from participants who did not want to see any changes to the current WIC food packages. a. Maximum Monthly Allowances The IOM recommended that fruits and vegetables be provided at levels of $10 per month for women and $8 per month for children. To achieve cost neutrality, the proposed rule would have established the value of fruit and vegetable vouchers at levels of $8 per month for women and $6 per month for children. A total of 3,166 commenters (2,940 of these form letters) asked FNS to increase the cash-value vouchers to the level recommended by the IOM so that participants could receive one additional serving of fruits and vegetables per day. Commenters cited (1) the important benefits of fruits and vegetables in decreasing high blood pressure, heart disease, obesity, and cancer; (2) the generally low consumption of fruits and vegetables among WIC participants; and (3) the role that WIC can play in helping participants meet the DGA\(1)\ for fruit and vegetable intake. Commenters urged FNS to seek additional funds to provide the cash-value vouchers at the level recommended by IOM. A total of 692 commenters (562 of these form letters) asked FNS to consider, at a minimum, increasing the cash-value fruit and vegetable voucher to $10 for fully breastfeeding women to further enhance the attractiveness of this package and provide an additional incentive for women to breastfeed. While FNS is in full agreement with the IOM and commenters regarding the benefits of fruits and vegetables for WIC participants, it is important that revisions to the WIC food packages be cost neutral to protect the program's ability to serve the greatest number of eligible women, infants, and children. For fruits and vegetables, the IOM's intent was to move WIC participants towards some amount of increased fruit and vegetable consumption and, at the same time, reinforce the role of the WIC food packages in nutrition education. The proposed $8 and $6 cash-value fruit and vegetable voucher fulfilled this intent while ensuring cost neutrality. Therefore, the provision will be retained in this interim rule as proposed for children and women in Food Packages III-VI in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11). However, FNS has considered the benefits of increasing the value of the vouchers for fully breastfeeding women and has determined that a $2 increase can be accomplished while maintaining cost neutrality. This provision is therefore revised in the interim rule in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11) to reflect a cash-value voucher of $10 for fully breastfeeding women in Food Packages III and VII. Thirty commenters (23 of which were form letters) preferred that a set amount of fruits and vegetables be authorized per month, e.g., 3 pounds for a child, in lieu of a cash-value voucher, for administrative ease and to control costs. FNS disagrees with this approach. A voucher, rather than a more narrowly defined fruit and vegetable option, offers flexibility, ensures participant access, and minimizes costs of [[Page 68970]] compliance by administrative agencies and WIC-approved vendors. Allowing participants to choose a wide variety of fruits or vegetables is intended to increase consumption by accommodating individual and culturally-based preferences. (1) State agency responsibility to make available to participants at least two fruits and two vegetables from the category of fruits and vegetables in each authorized food package. FNS proposed that State agencies be required to make available at least two fruits and two vegetables to participants in Food Packages III-VII. A total of 487 commenters (of which 418 were form letters) opposed the provision, believing that it undermines the IOM's recommendation to allow participants a wide variety of choices within the authorized fruit and vegetable options by authorizing State agencies to limit the number and variety of fruits and vegetables. FNS' intention with this proposed provision was to ensure participant choice among the fruit and vegetables authorized by the State agency by expanding current WIC regulations that require State agencies to make available at least one food from each group in each food package. As described in the preamble to the proposed rule, it was FNS' expectation that more than two varieties each of fruits and vegetables would be authorized by State agencies. Therefore, the proposed provision is clarified in the interim rule at 7 CFR 246.10(b)(2)(ii)(B) to ensure its original intent to require State agencies to allow participants to use their cash value vouchers to purchase any WIC-eligible fruits and vegetables from among those authorized in Table 4 of 7 CFR 246.10(e)(12). This allows participants a wide variety of choices within the authorized fruit and vegetable options without restriction, in keeping with IOM recommendations. Further, the proposed provision at 7 CFR 246.10(b)(1)(i) is revised in this interim rule to disallow further restrictions on eligible fruits and vegetables. (2) Minimum vendor stocking requirement. Similarly, at 7 CFR 246.12(g)(3)(i), FNS proposed that WIC authorized vendors carry a minimum of two varieties of fruits and vegetables to ensure participant choice at the retail level, while acknowledging that certain smaller vendors may not be able to stock as wide a variety of fruits and vegetables as larger vendors. A total of 472 commenters (418 form letters) disagreed with this provision, stating that setting a minimum vendor stocking requirement of two fruits and vegetables undermines the IOM recommendation to allow participants a wide variety of choices. Of these commenters, 269 (221 form letters) stated that State agencies should be allowed to specify minimum stocking requirements. FNS points out that the proposed provision authorizes State agencies to establish different minimums for different vendor peer groups, thus allowing State agencies the flexibility to work with vendors to provide the maximum number and variety of fruits and vegetables that are locally accessible, culturally appropriate and affordable. However, it is required that all authorized vendors must stock at least two varieties of fruits, two varieties of vegetables, and one whole grain cereal authorized by the State agency. Therefore, the provision at 7 CFR 246.12(g)(3)(i) is retained in the interim rule as proposed; however, a technical oversight in the proposed rule has been corrected by clarifying that authorized vendors must stock at least two different varieties of fruits and two different varieties of vegetables. b. Inflation Adjustment FNS proposed an option to increase the value of the cash-value fruit and vegetable vouchers by a whole dollar increment. A total of 124 commenters (75 of which were form letters) asked that FNS commit to a yearly inflation adjustment. FNS agrees with commenter that it is important to maintain the value of the vouchers over time. Cash-value vouchers will be set at $6 for children and $8 for pregnant and partially breastfeeding and $10 for fully breastfeeding women in the year in which the food package revisions take effect. This interim rule adds a provision at 7 CFR 246.16(j) to adjust the maximum value of the vouchers in whole dollar increments using the Bureau of Labor Statistics' Consumer Price Index for Fresh Fruits and Vegetables. c. Minimal Restrictions on Authorized Fresh Fruits and Vegetables To improve the consumption of fresh fruits and vegetables and to appeal to participants of different cultural backgrounds, the proposed rule would have authorized a wide variety of choices within the authorized fruit and vegetable options. To ensure nutritional integrity and cost neutrality, some minimal restrictions were proposed, e.g., no herbs or spices, edible blossoms of flowers, fruit leathers and fruit roll-ups. The majority of commenters favored the provision to authorize a wide variety of fruits and vegetables; however, 9 commenters (1 of which was a form letter) stated the opinion that the fruit and vegetable selections should be limited to sources of priority nutrients. As stated in the Regulatory Impact Analysis that was published in the Federal Register as an appendix to the proposed rule, FNS considered alternatives to the proposed provision, including authorizing a more restrictive dark green and orange vegetable provision. This alternative was rejected because FNS believes that WIC food packages that reflect the IOM recommendations as closely as possible within the constraints of cost neutrality best reflect current scientific consensus on how to meet the supplemental dietary needs of WIC participants. The IOM chose not to emphasize the dark green and orange vegetable groups that tend to offer the highest concentrations of certain priority nutrients and instead recommended a fruit and vegetable option with few restrictions. Nutrition education offered by local WIC agencies will remain the primary method of encouraging participants to incorporate these high nutrient fruits and vegetables into their diets; under this interim rule participants remain largely free to choose the fruits and vegetables that they find most appealing. Thirteen commenters (2 of which were form letters) believe that FNS should simplify the proposed minimal restrictions to ease interpretation and implementation for participants, vendors, and staff. A total of 128 commenters (125 of which were form letters) asked FNS to allow State agencies flexibility to promote produce selections that come in standard packages with Universal Product Codes to minimize burden. As stated above, the nutrition education provided to participants is intended not only to encourage participant choice in the selection of fruits and vegetables, but also to provide information on shopping tips to obtain the maximum value of the voucher. FNS is aware that State agencies will need to provide training and technical assistance to participants and vendors in implementing the food package changes. State agencies generally update their food lists on a biennial basis which requires training for both participants and vendors. Recognizing the extensive changes that will be necessary as a result of this rule, FNS will assist State agencies on vendor training, participant education, and other implementation issues. FNS also encourages State agencies to work with their vendor associations as they develop their new State procedures, particularly in regard to the cash-value fruit/vegetable voucher. [[Page 68971]] d. Disallowance of White Potatoes Under the proposed rule, white potatoes would have been excluded from authorization in the WIC food packages. A total of 324 commenters (of these 291 were form letters) opposed the restriction of white potatoes. Twenty-four commenters stated that white potatoes should be included in the WIC food packages because they are versatile, economical and contain key nutrients. Thirteen commenters (1 form letter) from WIC State and local agencies stated that the exclusion of white potatoes would be hard to administer. The restriction of white potatoes, as recommended by the IOM, is based on the amounts suggested in the DGA\(1)\ for consumption of starchy vegetables; food intake data indicating that consumption of starchy vegetables meets or exceeds these suggested amounts; and food intake data showing that white potatoes are the most widely used vegetable. Therefore, this provision is retained in the interim rule as proposed in Table 4 of 7 CFR 246.10(e)(12). e. Implementation of Fruit and Vegetable Options (1) Small dollar denomination of fruit and vegetable food instruments. In the preamble to the proposed rule, FNS encouraged State agencies to issue small denomination, i.e., $2, cash-value fruit and vegetable food instruments. The small denominations were encouraged so the participant could obtain small amounts of fresh produce at various times during the month, lessening the chance of food spoilage and waste. A total of 200 commenters (of which 133 were form letters) disagreed with FNS' recommendation to provide the fruit and vegetable value in small denominations. The majority of those in opposition were WIC State and local agencies who stated that they should be allowed to determine, in partnership with vendors, the most cost effective method to provide the fruit and vegetable food instrument. FNS clarifies that although State agencies are encouraged to provide the cash-value food instrument in small denominations for the reasons cited above and in the proposed rule, State agencies will determine the dollar denomination that is most beneficial to participants and cost effective given the State agency's infrastructure and environment. (2) Paying cash with the fruit/vegetable voucher. Nineteen commenters asked that participants be allowed to pay the difference when the purchase exceeds the value of the fruit/vegetable voucher. Under current rules at 7 CFR 246.12(c), State agencies must ensure that participants receive their authorized supplemental foods free of charge. Such a restriction is necessary with the ``traditional'' WIC food instrument which reflects a specific quantity of foods that a participant must receive. In contrast, the fruit/vegetable cash-value voucher reflects a maximum dollar allotment for the participant. Because it may be difficult to accurately estimate the exact purchase price of the fruit and vegetable selections, particularly when fresh and canned or frozen items are combined in one purchase, FNS concurs with commenters that participants should be allowed to pay the difference when the purchase of allowable fruits and vegetables exceeds the value of the fruit/vegetable voucher. This option would promote increased consumption of fruits and vegetables because participants would be more likely to utilize the full cash value, rather than partially redeem the voucher for fear of exceeding its cash value. The rule prohibits giving cash or credit to the participant for any unused portion of the fruit/vegetable voucher. (3) Benefit delivery. While most of the food package changes will be administered via existing State benefit delivery systems, the cash- value fruit/vegetable voucher will require changes to WIC benefit delivery systems to accommodate a more open-ended benefit determined by a cash value rather than a fixed quantity of a specific food item. State agencies and vendors must modify operations and procedures to issue, transact, and process the redemption of a cash value benefit. As described in the proposed rule, options for benefit delivery include Electronic Benefit Transfer (EBT) and farmers' markets. (4) Farmers' markets. A total of 936 commenters (of which 170 were form letters) agreed with the provision to allow the fruit/vegetable cash-value voucher to be redeemed by farmers at farmers' markets. Eleven commenters disagreed with the provision. Many commenters suggested that FNS ``Do no harm to the WIC Farmers' Market Nutrition Program (FMNP),'' and that funding for the FMNP not be reduced or procedures established that would adversely affect its operation or effectiveness. FNS would like to clarify that the regulatory requirements for the FMNP are unchanged by this interim rule. Many commenters incorrectly believed that the proposal would have allowed FMNP coupons to be redeemed at authorized WIC vendors. This is not true; the proposal would have allowed the WIC fruit/vegetable cash-value voucher to be redeemed at farmers' markets. Of the commenters supporting the provision to allow farmers at farmers' markets to accept the fruit/vegetable cash-value voucher, clarification was requested on several issues--would State agencies be required to authorize farmers at farmers' markets if they do not currently administer the FMNP; can farmers at farmers' markets be treated as seasonal vendors and only be allowed to accept the fruit/ vegetable voucher; can the State agency enter into one contract with the farmer that includes requirements for both WIC and the FMNP; and, can farmers' markets be excluded from the WIC vendor monitoring and audit requirements? In response to commenter questions, this interim rule will not require State agencies to authorize farmers to accept the WIC fruit/ vegetable voucher. If a State agency chooses to authorize farmers at farmers' markets, it may modify its standard vendor agreement to address the unique circumstances of farmers' markets, as allowed by 7 CFR 246.12(h)(2). For example, the farmer's market agreement may only allow the farmer to accept the fruit/vegetable cash-value voucher. In addition, the State agency can choose to enter into one agreement with the farmer that includes the requirements for both the WIC and WIC Farmers' Market Nutrition Programs. Further, farmers would be excluded from the vendor cost containment requirements. The farmers may also be excluded from the WIC monitoring requirements provided that they are included in the sample of farmers upon which the FMNP monitoring requirement is drawn. A new 7 CFR 246.12(v) has been added that specifies the requirements regarding the authorization of farmers at farmers' markets. The rule also adds definitions for cash-value voucher and farmer (the same as that used in the FMNP), and modifies the food instrument requirements to identify the provisions that do not apply to the cash-value voucher. As a result of the addition of the definitions of farmer and cash-value voucher, we have made conforming amendments to the definitions of ``compliance buy,'' ``employee fraud and abuse,'' ``participants,'' ``participant violations,'' ``proxy,'' and ``nutrition services and administration'' to include these new terms as appropriate. (5) Electronic Benefit Transfer (EBT). While the majority of State WIC agencies deliver benefits via paper checks or vouchers, 5 States are testing the feasibility of EBT and an additional State has adopted EBT statewide. [[Page 68972]] Although it will take a number of years to implement WIC EBT fully in all States, the fruit and vegetable benefit may provide opportunities for alternative forms of benefit delivery and allow some States to move toward limited electronic benefit processing prior to the implementation of EBT for all WIC purchases. In an effort to explore the range of possibilities for using existing commercial infrastructure to administer the fruit and vegetable benefit including WIC EBT smartcard and online solutions, commercial debit cards, and other technologies, FNS commissioned a study by the State Information Technology Consortium (SITC). Although the report is not yet final, preliminary findings indicate that for redemption of the fruit/ vegetable benefit, paper fruit and vegetable cash-value checks or vouchers appear to be the least costly and easiest to implement by State agencies and food vendors within a 12-month time period. The accountability for purchasing authorized fruits and vegetables remains the same as other food instruments--subject to training store clerks regarding eligible food items and State compliance monitoring. Debit type cards (EBT or credit/debit) with a magnetic strip offer potentially cost-effective solutions that leverage the widely available card payment infrastructure in the United States. Magnetic strip cards in volume can be purchased for less than 25 cents each. There are, for instance, many large and smaller food vendors that already accept credit card payments or accept EBT cards using a four digit Personal Identification Number (PIN). These vendors include most authorized WIC vendors. Focus groups with participants were favorable to this type of alternative because of lessened stigma while shopping and the ability to purchase foods incrementally rather than forfeiting some items with a paper instrument. Technical standards would need to be modified to enable card use only within authorized WIC vendor locations and there may be a need to define standards to facilitate retailer and/or EBT contractor changes to existing store equipment and software. The accountability for purchasing eligible foods only is similar to paper food instruments. WIC EBT solutions, on-line using magnetic-strip cards or off-line using smart cards, offer the greatest potential to ensure that only eligible fruits and vegetables are purchased with WIC cash-value vouchers, but it would be more costly for all stakeholders. These solutions would match each item scanned to a State list of authorized UPC's and/or Price Look-Up codes or PLUs. These solutions require additional investment by State agencies in cards, equipment, and maintenance of a much larger number of product Universal Product Codes and Price Look-Up (PLUs) codes for fresh produce. The fresh produce industry has taken steps to institute greater standardization of PLUs; however, the seasonal and local produce suppliers do not always have means to use PLUs effectively. The draft SITC report suggests that pilot design and development will be necessary to identify cost effective solutions that can be widely adopted by State agencies and authorized vendors. 2. Peanut Butter and Legumes The proposed rule would have added 18 ounces of peanut butter in Food Package V to improve the intake of several nutrients in the diets of pregnant and breastfeeding women. The proposed rule would also add legumes (dried beans/peas or peanut butter) in Food Package VI for postpartum women. Canned beans were proposed as an optional substitute for dry beans in Food Packages III-VII. Of the 3,091 comment letters that addressed these provisions, 3,085 commenters (21 form letters)--a large majority of whom were participants--were in favor of the proposed changes. Six commenters asked that FNS eliminate peanut butter in the food packages for children because of concerns about peanut allergies. The IOM advised that children should avoid eating peanut butter from a spoon for safety reasons until age 3, but recommended that peanut butter continue to be offered in the WIC food packages for young children from 1 to 5 years of age. IOM has advised FNS that assessing for allergies and tailoring a young child's food package based on such assessment, as is current practice in WIC, is appropriate. Therefore, the proposed peanut butter and legume provisions are retained in this interim rule as proposed. 3. Milk and Milk Alternatives a. Maximum Monthly Milk Allowances The proposed rule would have decreased the maximum monthly allowances for milk in all food packages--for children and postpartum women, from 24 quarts to 16 quarts; for pregnant and partially breastfeeding women, from 28 to 22 quarts; and for fully breastfeeding women, from 28 quarts to 24 quarts of milk. Reducing the amount of milk provided through WIC is consistent with recommended limits on saturated fat, total fat, and cholesterol consumption put forth in the DGA,\(1)\ better aligns the amount of milk provided by WIC with the amounts recommended by the DGA\(1)\ and is consistent with the supplemental nature of the WIC Program. The majority of non-participant commenters were in favor of the proposed reductions in milk. A total of 2,088 non-participant commenters (1,874 of which were form letters) were supportive of the reductions, while 66 commenters were opposed. Commenters opposing the reductions cited the contribution of milk to intakes of priority nutrients for WIC participants, e.g., calcium, Vitamin A, and potassium. Seventeen commenters stated that the food package for postpartum women should be increased to the levels provided to pregnant and partially breastfeeding women. Six commenters urged FNS to maintain milk at current levels and increase funding for other proposed food package provisions. Comment letters from program participants reflected disappointment with the reductions in milk. A total of 1,831 comment letters were received from program participants who opposed the reductions; 225 participants wrote in favor of the proposed reductions. FNS believes that the IOM set forth a series of science-based recommendations that, taken together, balance the various supplemental nutritional needs of participants. According to the IOM, amounts of milk provided by the WIC food packages need not exceed amounts recommended by the DGA.\(1)\ The proposed dairy levels for children (2 cups/day) and pregnant and breastfeeding women (3 cups/day) provide at least 100 percent of the servings recommended by the DGA.\(1)\ The level for non-breastfeeding postpartum women is at least \2/3\ of the amount set forth by the DGA.\(1)\ The proposed maximum monthly allowance of milk allows a more balanced food package to provide the various high priority nutrients within cost constraints. Therefore, the proposed maximum allowances for milk are retained in this interim rule in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11). b. Low-Fat Milk Under the proposed rule, only whole milk (not less than 3.25% milk fat) would have been authorized for children less than 2 years of age. For children two years of age and older and women, the proposed rule would have authorized only milk with no more than 2% milk fat to be consistent with current recommendations of the DGA [[Page 68973]] 2005 to limit saturated fat and dietary cholesterol intake. A total of 3,058 commenters (2,663 of which were form letters) agreed with the provisions as written; 222 (10 of which were form letters) were opposed. One hundred seventy of those opposed were program participants. A total of 1,379 commenters (1,338 of which were form letters) stated that the fat content of milk for children and women should be reduced even further--to no more than 1% of milk fat. Seventy-eight commenters (23 of which were form letters) asked FNS to allow the CPA the authority to prescribe the type of milk (whole milk or low fat milk) to participants, regardless of age or category, if medically necessary for such reasons as failure to thrive, underweight or overweight. FNS' position is that participants who have medical conditions that lead to a diagnosis of failure to thrive will likely be issued Food Package III. Therefore, to address commenters' concerns, this interim rule will authorize whole milk for children 1 through 4 years of age and women in Food Package III, with medical documentation. As proposed, only milk with no more than 2% milk fat is authorized for children 2 years of age and older and women in Food Packages IV-VII. For these participants, nutrition education directed towards appropriate foods and food amounts should be provided for underweight or overweight 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. c. Lactose Free Milk Under the proposed rule, as long as a milk conforms to the FDA standard of identity for milk as defined by 21 CFR Part 131 and meets WIC Federal requirements, it would be an authorized milk in Food Packages IV, V, VI, and VII. Although not specified in the proposed rule, authorized milks that conform to the FDA standard of identity include, but are not limited to, calcium-fortified, lactose-reduced and lactose-free, acidified, and ultra-high temperature (UHT) milks. FNS clarifies that these products are authorized, and that lactose-free or lactose-reduced dairy products should be offered before non-dairy milk alternatives to those participants with lactose intolerance who cannot drink milk. FNS also clarifies that medical documentation is not required for participants to receive lactose-reduced and lactose-free milk. d. Authorized Substitutions for Milk (Cheese, Tofu, Soy-Based Beverage) (1) Cheese. The proposed rule would have reduced the amount of cheese that may be substituted for milk to one pound per month for children and pregnant, postpartum and partially breastfeeding women, and two pounds for fully breastfeeding women. Reducing the amount of cheese that may be substituted for milk will reduce saturated fat and total fat intake by children age two and older and women consistent with the DGA\(1)\ recommendations. Amounts of cheese that exceed the maximum substitution amounts may be authorized with medical documentation in cases of lactose intolerance or other qualifying conditions. The majority of non-participant commenters were in favor of the proposed reduced cheese substitution amounts. A total of 754 non- participant commenters (of which 589 were form letters) were supportive of the reduced substitution amounts, while 53 commenters were opposed. A total of 917 comment letters were received from program participants who opposed the proposed cheese allowances; 119 participants wrote to express support for the proposed amounts. Commenters opposing the cheese substitution amounts stated that cheese is culturally acceptable to most populations, and provides nutrients in a convenient and familiar way. Fourteen commenters asked FNS to maintain cheese at its current substitution levels and emphasize or require reduced-fat cheese. Reducing the maximum amount of cheese lowers the amount of saturated fat, total fat, and cholesterol in the WIC food packages. Within the context of the proposed revisions to the WIC food packages as a whole, the reductions in the current levels of cheese ensure that FNS is able to provide a more balanced nutrient intake for WIC participants while maintaining cost neutrality. Therefore, the proposed substitution levels for cheese are retained in this interim rule. (2) Soy-based beverage and tofu. To provide more flexibility for WIC State agencies and more variety and choice for WIC participants, the proposed rule would have authorized soy-based beverage to be substituted for milk for women in Food Packages V, VI and VII at the rate of 1 quart of soy-based beverage for 1 quart of milk up to the total maximum allowance of milk. The proposal also would have allowed calcium-set tofu to be substituted at the rate of 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk could be substituted in this manner in Food Packages V and VI, and a maximum of 6 quarts of milk may be substituted in Food Package VII. Under the proposed rule, soy-based beverage and tofu would not be allowed as substitutes for milk for children in Food Package IV without medical documentation. The qualifying conditions may include, but are not limited to, milk allergy, severe lactose maldigestion, and vegan diets. Amounts of tofu that exceed the maximum substitution amounts may be authorized for women, with medical documentation, in cases of lactose intolerance or other qualifying conditions. A total of 8,932 commenters (4,615 form letters) were supportive of adding soy-based beverage and tofu to the WIC food packages as milk substitutes; 368 commenters (148 form letters) were not supportive. Comments received on medical documentation requirements for soy-based beverage for children and FNS' rationale for retaining the provision in this interim rule as initially proposed are discussed in section IV.B.4. of this preamble. As stated in the preamble to the proposed rule, Section 102 of the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-265) requires that nondairy beverages offered as an alternative to fluid milk in the National School Lunch Program and School Breakfast Program must be nutritionally equivalent to fluid milk and meet nutritional standards set by the Secretary of Agriculture. FNS, therefore, proposed that authorized soy-based beverage provide, at a minimum, the following nutrients: Calcium............................. 276 milligrams (mg) per cup. Protein............................. 8 grams per cup. Vitamin A........................... 500 International Units (IU) per cup. Vitamin D........................... 100 IU per cup. Magnesium........................... 24 mg per cup. Phosphorus.......................... 222 mg per cup. Potassium........................... 349 mg per cup. Riboflavin.......................... 0.44 mg per cup. Vitamin B12......................... 1.1 mcg per cup. A total of 340 commenters (255 form letters) were opposed to the proposed minimum nutrient standard, stating that fortification at these levels is not necessary, and that soy-based beverage meeting the proposed minimum nutrition standard are not available in the marketplace. FNS believes that it is imperative for WIC and the school nutrition programs to use the same standards for defining allowable soy-based beverage as alternatives to fluid milk. Therefore, the proposed minimum nutrient standard for soy-based beverage [[Page 68974]] is retained in this interim rule. FNS is aware of at least one soy- based beverage in the marketplace that meets these requirements and anticipates that the marketplace will respond with additional products. To the extent that the marketplace doesn't respond with additional products, other options, such as tofu, are available for participants. (3) Yogurt. The IOM recommended adding yogurt to the WIC food packages as a milk substitute for children and women. However, in order to maintain cost neutrality, the proposed rule did not include yogurt. Of the 758 commenters that addressed yogurt, 749 (617 form letters) disagreed with FNS' decision not to include yogurt. Commenters stated that yogurt provides priority nutrients, and is convenient, popular, and culturally acceptable to WIC participants. FNS agrees that yogurt would be a desirable dairy alternative to milk for WIC participants; however, the cost is simply prohibitive ($413.9 million over 5 years). In addition, FNS has determined that WIC participants will be able to get the calcium provided by yogurt through other foods authorized in these revised food packages. Lactose-free and lactose-reduced dairy products, for example, are readily available in both urban and rural areas for those WIC participants with lactose intolerance. Calcium-set tofu and soy-based beverages are available to accommodate cultural preferences. Also, as noted earlier, a new 7 CFR 246.10(i) has been added to this interim rule to allow State agencies the flexibility to meet unanticipated cultural needs of participants. It is important that revisions to the WIC food packages be cost neutral to protect the program's ability to serve the greatest number of eligible women, infants, and children. Therefore, FNS is unable to authorize yogurt in the WIC food packages in this interim final rule. However, FNS solicits comments from State agencies as they implement the provisions of this interim rule about the extent to which WIC participants would benefit from the addition of yogurt, and whether that addition would be achieved in a cost-effective way. In particular, we are interested in the impact of adding yogurt for women in Food Packages V-VII. FNS also solicits comments as to the feasibility of rebate agreements between yogurt manufacturers and individual States, so that yogurt could be provided to specific participant groups in the WIC program while maintaining cost-neutrality. State agencies are currently encouraged to explore the feasibility of cost containment systems, especially rebates, and to implement such a system where feasible for other WIC foods. In an effort to use their food grants more efficiently, 13 State agencies, which include 3 multi-State contracts, have rebate contracts for juice (frozen and shelf), infant juice and/or infant cereal. If FNS were to consider including yogurt as a WIC- eligible food through future rulemaking, FNS would be interested in the following types of information: Which participant groups would most benefit from having yogurt included as part of their food package? Would States be able to secure rebates sufficient enough to add yogurt for all or certain participant groups while maintaining cost-neutrality? Finally, and as noted earlier, Section 203(c) of Public Law 108-265 amended Section 17(c)(2) of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by requiring the Secretary to conduct, as often as necessary, 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 used to determine the need for yogurt. 4. Eggs Under the proposed rule, the maximum monthly allowance for fresh shell eggs would have been reduced from the current 2 or 2\1/2\ to 1 dozen fresh shell eggs for children and women in Food Packages IV, V, and VI. For fully breastfeeding women in Food Package VII, the maximum monthly allowance was proposed at 2 dozen eggs. A total of 1,469 commenters (266 of which were form letters) addressed the proposed egg reduction provision. Of the 492 non- participant commenters, 406 were in favor of the proposed reductions. Those opposing stated that eggs provide important nutrients at relatively low cost. Of the 1,009 program participants who commented, 923 were opposed to the reduction in eggs. The proposed maximum monthly allowance of eggs is consistent with recommendations of the IOM \(3)\ and the DGA \(1)\ to reduce cholesterol. In addition, the IOM determined that protein is no longer a priority nutrient for the WIC population. Within the context of the proposed revisions to the WIC food packages as a whole, the reductions in the current levels of eggs ensures that FNS is able to provide a more balanced nutrient intake for WIC participants while maintaining cost neutrality. Therefore, the proposed maximum monthly allowances for eggs are retained in this interim rule. 5. Juice for Children and Adults The proposed rule would have reduced the maximum allowances of juice for women and children in Food Packages IV-VII. According to the IOM, deleting or reducing the quantity of juice in the WIC food packages helps allow for the inclusion of whole fruits and vegetables while containing food costs, and is consistent with recommendations of the DGA\(1)\ and the American Academy of Pediatrics (AAP). For children, the proposed maximum monthly allowance of juice would have been reduced from 288 fluid ounces to 128 fluid ounces. For pregnant and partially breastfeeding women, the proposed maximum monthly allowance of juice was reduced from 288 fluid ounces to 144 fluid ounces; for postpartum women from 192 fluid ounces to 96 fluid ounces; and for fully breastfeeding women, from 336 fluid ounces to 144 fluid ounces. A total of 2,256 commenters (846 form letters) addressed the proposed reductions in juice. Of these, 1,610 commenters (846 form letters) were supportive of the juice reductions. Eighty two of those commenters recommended that juice be eliminated entirely from the WIC food packages and replaced with fruits and vegetables. Of the 646 commenters that opposed the reduction in juice, 633 were program participants. Non-participant commenters who opposed the reductions cited the nutritional benefits of juice and stated that the proposed reductions were too drastic. Reducing the quantity of juice in the WIC food packages helps allow for the inclusion of whole fruits and vegetables while containing food costs. The reduction in the amount of juice provided for children to about 4 ounces per day is consistent with the AAP recommendation for that age group. The AAP also notes that juice does not provide any additional nutritional benefit beyond that of whole fruit. The reduced amount of juice for women is consistent with the recommendation of the DGA\(1)\ that whole fruits be used for a majority of the total daily amount of fruit. Additionally, 34 commenters (14 form letters) expressed concern that juice package sizes need to be considered to ensure the full nutritional benefit of juice is received by participants. Over the years, there have been many changes in package sizes for all WIC- eligible food categories, and FNS has struggled with how to manage these changes [[Page 68975]] within WIC Program regulations that allow for a monthly maximum allowance of food that cannot be exceeded (except for the rounding option for infant formula and infant foods). It is not practical for FNS to be able to respond to all the variations in package sizing. Basing the maximum monthly allowance on package sizes would not guarantee that those package sizes will not change over time. Therefore, FNS is retaining the proposed maximum juice allowances for children and women in this interim rule. 6. Whole Grains and Breakfast Cereals To support the DGA\(1)\ recommendations to consume at least 3 servings per day of whole grains to reduce the risk of coronary heart disease and type 2 diabetes, to help with body weight maintenance, and to increase intake of dietary fiber, the proposed rule would have established a whole grain requirement for breakfast cereal in Food Packages III-VII and added whole wheat bread or other whole grain options for children and pregnant and breastfeeding women in Food Packages III, IV, V and VII. The addition of whole grains to the WIC food packages was popular across all commenter categories. A total of 17,165 comment letters (7,983 form letters) agreed with the whole grain provisions and 113 comment letters (5 form letters) disagreed with the provisions. While strongly supporting FNS' emphasis on whole grains, 876 commenters (764 form letters) expressed concern that the proposed nutritional requirement for whole grain breakfast cereal--using labeling requirements for making a health claim as a ``whole grain food with moderate fat content'' as defined by the Food and Drug Administration (FDA) in its December 9, 2003, Health Claim Notification for Whole Grain Foods with Moderate Fat Content at http://www.cfsan.fda.gov/~dms/flgrain2.html_is too restrictive. Commenters stated that the proposed provision would eliminate corn and rice-based cereals that are necessary for participants with wheat allergies or strong preferences for corn and rice-based cereals, as well as severely limit the total variety and choice of WIC-eligible cereals. In addition, 77 commenters (21 form letters) also stated that whole grain foods are less palatable to young children, may not be preferred by certain cultures, and therefore may not be chosen by participants, potentially negating FNS' goal to help participants increase whole grain consumption. Additionally, commenters pointed to (1) potential administrative difficulties in the identification of whole wheat bread and whole grain cereals by State agency staff when determining which products are WIC- eligible; and (2) confusion by vendors and participants at the point of purchase due to lack of consistency in food labels that do not clearly identify foods as meeting the FDA standard of identity for whole wheat bread or the labeling requirement for making the health claim as ``a whole grain with moderate fat content.'' Commenters suggested several alternatives for determining a nutritional standard for whole grain cereals including the elimination of any requirement for whole grain, adoption of an 8-gram per serving standard, and exemption of certain cereals from the whole grain requirement. FNS finds merit in commenters' concerns that the proposed whole grain nutritional requirement for breakfast cereal would eliminate corn and rice-based cereals, as well as severely limit the variety and choice of WIC-eligible breakfast cereals; and that whole grain breakfast cereals may be less palatable to participants, especially children, and less preferred by certain cultures. WIC- eligible breakfast cereals are the major source of iron in the WIC food packages for children and women and research shows that participation in WIC has a positive impact on the iron status of its participants. The IOM pointed out that despite declines in the prevalence of iron- deficiency, this deficiency remains a nutrition-related health risk for children and women of reproductive age. Acceptability of eligible foods by participants is an important factor in the decision to authorize types and brands of foods for State food lists and therefore, in this interim rule, the provision at 7 CFR 246.10(e)(12) is revised to require that at least one half of the total number of breakfast cereals on the State's authorized food list meet the whole grain requirement using the FDA labeling requirements for making a health claim as a ``whole grain food with moderate fat content.'' Further, to assist in the identification of whole grain cereals for State agencies, vendors and participants, the interim rule adds the requirement that the primary ingredient by weight must be a whole grain. The remaining authorized breakfast cereals are required to meet only the iron and sugar requirements. State agencies may opt that all or more than half of the cereals on the State's authorized food list meet the whole grain requirement. However, in establishing minimum requirements for the variety and quantity of foods that a vendor must stock to be authorized, State agencies must require that at least one whole grain cereal be available. FNS believes that the revisions to the proposed whole grain provisions for cereals in this interim rule will continue to support the goals of the DGA\(1)\ for increasing whole grain consumption. State agencies are reminded that 7 CFR 246.10(b)(1)(i) allows the State to establish criteria in addition to the minimum Federal requirements for WIC supplemental foods, e.g., no artificial sweeteners. FNS also finds merit in commenters' concerns about administrative difficulties in the identification of whole wheat bread and whole grain products. It is important that WIC nutritional requirements be simple and accurate for State agencies to use when determining foods to authorize for State food lists and that authorized whole wheat and whole grain products make significant contributions of whole wheat or whole grain to the WIC food packages. Therefore, the proposed requirements for whole wheat bread --any bread that conforms to the FDA standard of identity for whole wheat bread as defined by 21 CFR 136.180 will be retained in this interim rule. However, to assist in the identification of whole wheat bread products for State agencies, vendors and participants, the interim rule adds the requirement that the primary ingredient by weight must be whole wheat. FNS also clarifies in this interim rule that whole wheat buns and rolls that meet the FDA standard of identity for whole wheat bread, and have whole wheat as their primary ingredient, are WIC-eligible. The proposed requirements for whole grain breads--any bread product that meets labeling requirements for making a health claim as a ``whole grain food with moderate fat content'' as defined by FDA in its December 9, 2003, Health Claim Notification for Whole Grain Foods with Moderate Fat Content at http://www.cfsan.fda.gov/~dms/flgrain2.html_will also be retained in this interim rule. However, the interim rule adds the requirement that the primary ingredient by weight must be whole grain. The revisions to the whole wheat and whole grain bread requirements will allow products that are 100% whole grain, or are primarily whole wheat or multi-grain, to be WIC-eligible as well as provide an easy way for participants and vendors to identify whole wheat and whole grain bread products by using the food label. The primary ingredient is easily identified on the food label since ingredients are listed in [[Page 68976]] descending order of predominance by weight. To ensure that the whole grain options are consistent with the intent of the IOM recommendations, this interim rule also clarifies that the brown rice, bulgur (cracked wheat), oatmeal, and barley (whole-grain) are the whole unprocessed grain, and that soft corn and whole wheat tortillas must have the whole grain as the primary ingredient by weight according to the food label. A technical oversight in the proposed food package rule has been corrected in this interim rule by removing the requirement that authorized soft corn or whole wheat tortillas contain no added fats or oils. In the interim rule, State agencies will continue to be responsible for determining which types and brands of whole wheat bread and whole grain products and breakfast cereals to authorize on State food lists using the minimum requirements and specifications in Table 4 at 7 CFR 246.10(e)(12). FNS will provide information on label reading and marketplace availability to State agencies to assist in the identification of whole wheat and whole grain foods and on nutrition education that encourages increased consumption of whole grains. The assistance of industry is requested in notifying FNS of whole wheat and whole grain bread products, whole grain cereals, and whole grain options that may meet the newly established nutritional requirements. Information may be mailed or sent electronically to FNS at the addresses provided at the beginning of this preamble. Maximum Monthly Allowance The proposed rule would have established a maximum monthly allowance of 2 pounds of whole wheat bread or other whole grain options for children in Food Packages III and IV; and 1 pound of whole wheat bread or other whole grain options for women in Food Packages III, V and VII. The rule proposed a maximum monthly allowance of 36 ounces of breakfast cereal for children and women in Food Packages III-VII. While supporting the addition of whole wheat bread and other whole grain options to the WIC food packages, 95 comment letters (38 form letters) expressed concern that the package sizes of bread are not commonly available in either one- or two-pound loaves and that the participants would have difficulty purchasing the maximum monthly allowance for whole wheat bread. FNS has long recognized that package sizes of WIC- eligible foods vary among manufacturers and those manufacturers may change package sizes at any time. Over the years, there have been many changes in package sizes for all WIC-eligible food categories, and FNS has struggled with how to manage these changes within WIC Program regulations that allow for a monthly maximum allowance of food that cannot be exceeded (except for the rounding option for infant formula and infant foods). It is not practical for FNS to be able to respond to all the variations in package sizing. Basing the maximum monthly allowance on package sizes would not guarantee that those package sizes will not change over time and, therefore, the maximum monthly allowance for whole wheat bread and other whole grain options and breakfast cereal remains as proposed. 7. Canned Fish The proposed rule would have authorized 30 ounces of a variety of canned fish in Food Package VII for fully breastfeeding women. The following varieties of canned fish were proposed--light tuna, salmon, and sardines. In the proposed rule, FNS solicited input on additional canned fish to offer in Food Package VII. A total of 3,546 commenters (26 form letters) expressed support for the proposed canned fish provisions; 555 commenters opposed. Of the opposing comment letters received, 506 were variations of one form letter submitted as part of a letter writing campaign initiated by an advocacy organization concerned with the public's exposure to methylmercury. These and other opposing commenters believe that canned light tuna should be eliminated from the WIC food packages until more study is conducted on its mercury content. Two commenters (1 form letter) opposed the omission of albacore tuna from the list of authorized varieties of canned fish. The IOM recommended that a variety of canned fish that do not pose a mercury hazard be offered in Food Package VII. As identified by federal advisories of the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA),\(4)\ canned light tuna, salmon, and sardines are among those fish that are lower in mercury. For ease of administration by State agencies, to accommodate participant preferences, and to minimize intake of mercury, this interim rule retains the proposed varieties of canned fish in Food Package VII for fully breastfeeding women. In response to commenters' requests, canned mackerel--N. Atlantic and Chub (Pacific)--also identified as lower in mercury, has been added in this interim rule as an authorized canned fish in Food Package VII. 8. Proposed Food Packages I and II for Infants The rule proposed the following changes in Food Packages I and II for infants: Revise age specifications for assignment to infant food packages; Delay introduction of complementary food to six months of age; Establish 3 feeding options within each infant food package--fully breastfed, partially breastfed, or fully formula fed; Revise maximum monthly infant formula allowances; Add infant food fruits and vegetables in Food Package II; Eliminate juice from both infant food packages; Disallow provision of infant formula for breastfed infants during the first month after birth; Disallow low iron infant formula; Allow commercial infant food meat for fully breastfed infants in Food Package II; and Reassign infants with a qualifying condition to proposed Food Package III--Participants With Qualifying Conditions--and authorize the issuance of exempt infant formulas only in Food Package III. The proposed revisions to Food Packages I and II for infants were designed to better promote and support the establishment of successful long-term breastfeeding among women who choose that feeding method, address differences in nutritional needs of breastfed and formula fed infants, address developmental needs of infants, bring the infant food packages in line with current infant feeding practice guidelines from the AAP, and serve all participants with certain medical conditions under one food package to facilitate efficient management of medically fragile participants. a. Food Package I for Infants Under Six Months Under current WIC regulations, a maximum formula allowance is specified for all infants assigned to Food Package I, regardless of infant feeding practice; WIC staff may tailor the amount of formula to reflect the individual needs of the infants. The proposed rule would have extended the age range of infants covered by Food Package I by two months, thereby delaying introduction of complementary foods previously offered in this food package (juice and cereal) until six months of age. In proposed Food [[Page 68977]] Package I, fully formula fed infants four through five months of age would receive a slightly increased amount of infant formula to compensate in part for the decrease in nutrients and calories that results from the omission of juice and infant cereal. Also, to more actively support successful breastfeeding, the proposed rule would set a maximum formula amount for partially breastfed infants in Food Package I that is roughly half the maximum provided to fully formula fed infants. b. Food Package II for Infants Six Through Eleven Months Under the proposed rule, the amounts of formula and the amounts and type of infant foods would vary by infant feeding option. Infant food fruits and vegetables would be added to Food Package II, infant juice eliminated, and maximum formula allowances reduced for both partially breastfed and fully formula fed infants. The majority of commenters were supportive of the revisions to the infant food packages as proposed. The discussion that follows pertains to those provisions that received significant or substantial opposing comments, suggested alternatives, or requests for clarifications. Provisions related to the proposed food packages for infants that are not addressed in this preamble did not receive significant or substantial public comments and are therefore retained in this interim rule as proposed. c. Breastfeeding Provisions The proposed food packages for infants and women were designed to strengthen WIC's breastfeeding promotion efforts and provide additional incentives to assist mothers in making the decision to initiate and continue to breastfeed. The IOM's three-pronged approach to better promote and support breastfeeding through the WIC food packages was proposed. The approach focuses on the market value of the package for the mother/infant pair for the first year after birth, addresses differences in supplementary nutrition needs of breastfed and formula fed infants, and considers how to minimize early supplementation with infant formula through continued or increased efforts to promote and support the breastfeeding dyad. Because early supplementation may contribute to the short duration of breastfeeding, only two infant feeding options were recommended initially after delivery--either full breastfeeding or full infant formula-feeding. The IOM recommended this approach because physiology provides a strong basis for avoiding supplemental formula. The amount of milk a breastfeeding woman produces depends directly on how often and how long she nurses. Providing supplemental formula to a new breastfeeding mother may interfere with her milk production and success at continued breastfeeding. The differences in the proposed packages for the mother-infant pairs were based on differences in nutritional needs. For example, fully breastfeeding women require additional calories per day during the first six months postpartum as well as higher levels of most vitamins and minerals. Thus, the package for fully breastfeeding women provides the most food energy and nutrients, and the package for fully formula-feeding women provides the least. Similarly, starting at age six months, the proposed package for fully breastfed infants would have included commercial infant food meats to add a source of iron and zinc. These proposed food package changes, as recommended by the IOM, were intended to strengthen WIC's efforts to promote and support breastfeeding as the optimal infant feeding choice for WIC mothers. In general, commenters expressed support for the proposed breastfeeding provisions. Of the 1,057 commenters (774 form letters) that made statements regarding the breastfeeding provisions, 1,017 (753 form letters) were supportive of the provisions, stating that they add value and incentive for mothers to breastfeed and support WIC's efforts to promote breastfeeding as the optimal infant feeding choice. The largest number of opposing comments on the breastfeeding provisions focused on those related to the establishment of infant feeding options the first month after birth, as described below. Establishment of Infant Feeding Options--First Month After Birth To support the successful establishment of breastfeeding, the proposed rule would have established two infant feeding options for the first month after birth, either full breastfeeding or full formula- feeding. Under the proposed rule, infant formula would not be provided for fully or partially breastfeeding infants during the first month of life after birth. The IOM recommended this approach because providing supplemental formula to a new breastfeeding mother may interfere with her milk production and success at continued breastfeeding. A total of 862 commenters (540 form letters) addressed this provision. Of those, 195 commenters (102 form letters) agreed with the provision as written. A total of 667 commenters (438 form letters) were opposed. While agreeing with its premise--that early supplementation inhibits the establishment of successful breastfeeding in the critical early weeks of an infants life--opposing commenters expressed concern that some WIC State and local agencies may not be prepared to provide support services (peer counselors, breast pumps, consultation with lactation experts) to the extent necessary to make this provision work for every mother. As a result, a mother who feels less than confident about her ability to breastfeed may choose to either (1) categorize her infant as fully formula fed, thus receiving more formula than is necessary for the breastfeeding infant and further compromising the establishment of successful breastfeeding, or (2) not breastfeed at all. Other commenters pointed to legitimate medical reasons that a breastfeeding mother/infant dyad may have which result in the need for supplemental formula in the early postpartum period, such as infants with metabolic disorders. Commenters urged FNS to consider allowing State agencies the option to provide a small amount of infant formula during the first month in limited situations. FNS finds the arguments put forth by commenters compelling. Therefore, the provisions at 7 CFR 246.10(e)(1)(ii)(A) and in Table 1 of 7 CFR 246.10(e)(9) are revised as follows. Three infant feeding options will be authorized in the first month after birth--either (1) fully formula feeding; (2) fully breastfeeding; or (3) partially breastfeeding. As proposed, no supplemental formula will be provided for fully breastfeeding infants. The third infant feeding option-- partially breastfeeding--will be offered to the infant who is breastfed but also receives not more than 104 reconstituted fluid ounces of formula from the WIC program. Food Package V will be provided to mothers of these partially breastfeeding infants. Partially breastfed infants ages 0 to 1 month may receive the equivalent of not more than 104 fluid ounces of reconstituted infant formula. This will allow State agencies to issue one can of powder infant formula commonly used in WIC, and is responsive to commenters' requests to make a small amount of infant formula available for partially breastfeeding infants in the first month. Powder infant formula is recommended until the partially breastfed infant reaches four months of age due to its longer shelf life and to minimize waste. The CPA is expected to individually tailor the amount based on [[Page 68978]] the carefully assessed needs of the individual breastfeeding infant. This means that mothers of partially breastfed infants should not ``automatically'' be provided a can of formula in the first month of life. If, after a careful assessment, the CPA determines that some formula is appropriate for the infant in the first month, the mother should be advised on the appropriate amount of that one can of formula to feed the infant. The goal is to provide as minimal amount of supplemental formula as is needed, while offering counseling and support, in order to help the mother establish a successful milk supply. FNS is aware that adequate breastfeeding support for mothers is important for the success of both the partially and fully breastfeeding options in the first month after birth. FNS is committed to strengthening WIC's efforts to promote and support breastfeeding, through the provision of peer counseling funding to State agencies and other means. Judicious use of NSA funds by State agencies directed toward research-based support known to be effective--i.e., peer counseling, consultation with lactation experts--will further enhance the ability of State and local agencies to assist mothers in establishing and continuing successful breastfeeding in the critical weeks after birth and beyond. FNS' view is that the provision of a small amount of formula for certain infants in the first month of life is a temporary option that State agencies may invoke to assist breastfeeding mothers who may otherwise choose to fully formula feed. FNS expects that the proportion of participants offered the partially breastfeeding option in the first month will decrease over time as State agencies strengthen their breastfeeding support infrastructure. d. Maximum Monthly Allowances of Infant Formula Under the proposed rule, the maximum monthly allowance of infant formula would be revised from current levels to reflect the proposed feeding options (fully formula feeding, partially breastfeeding, and fully breastfeeding), physical form of infant formula provided (liquid concentrate, powder, or ready-to-feed), and the age of the infant. A total of 574 commenters (143 form letters) addressed the maximum monthly allowances of infant formula. Two hundred forty four commenters were opposed to changes in the maximum monthly allowances; of these, 148 were program participants. The majority of comments centered on two specific issues: (1) The variation in amounts of formula provided during the different age specifications; and (2) a decrease in amount of formula available, especially for the 6-12 month old infant. Non- participant commenters in opposition to revising formula allowances stated that reducing formula will result in supplementation with whole milk or inappropriate liquids. Some non-participant commenters stated that formula amounts should stay the same as in current regulations and the CPA should tailor the packages as appropriate for the needs of individual infants. Participant commenters expressed concern that formula is expensive and if WIC reduces the amount provided it will increase their out-of-pocket expenses to purchase the additional formula. The proposed maximum formula allowances for infants were determined based on a scientific review of the calorie and nutrient needs of infants at different ages. The proposed amounts of infant formula for partially breastfeeding infants in Food Packages I and II are designed to enhance the promotion and support of breastfeeding. The provision is part of the IOM's comprehensive approach resulting from thorough consideration of scientific research and public comments on how to promote and support breastfeeding. The maximum amount for partially breastfed infants provides approximately half the amount provided to fully formula fed infants--to provide about half of the infant's nutritional needs to encourage the mother to breastfeed enough to provide at least half of the infant's nutritional needs. This approach is preferable to current tailoring because it establishes a standard procedure that promotes breastfeeding as the optimal way to feed infants across WIC programs. The addition of infant foods, along with the proposed amount of formula for infants in Food Package II, provides close to recommended amounts of nutrients, introduces more variety into the infant's diet and encourages healthy dietary patterns. FNS believes that the nutrition education and anticipatory guidance on infant feeding provided by WIC local agencies will enable participants and caregivers to make informed choices about appropriate liquids for infants. Other commenters asked for clarification on the maximum monthly allowances of infant formula per physical form and suggested that the maximum monthly allowance for infant formula be the same for all physical forms. The IOM recommended a maximum monthly allowance of liquid concentrate but stated that powder or ready-to-feed formula (RTF) may be substituted for liquid concentrate at rates that provide the approximate number of fluid ounces as the liquid concentrate. The IOM recommended rounding to whole cans to approximate the target amount. FNS recognizes that powder infant formula is an increasingly popular physical form with WIC agencies and participants. In determining the amount of powder formula to authorize, FNS considered the cans sizes commonly used in WIC, their reconstituted yields, and the range of dry powder ounces recommended by the IOM. The maximum monthly allowance of powder infant formula provides at least the number of fluid ounces as the same reconstituted liquid concentrate for the 3 major milk-based infant formulas manufactured that State agencies issue, thereby ensuring a minimum level of nutrition for infants regardless of physical form. As described in section C.8.c. of this preamble, partially breastfed infants ages 0 to 1 month may receive the equivalent of not more than 104 fluid ounces of reconstituted infant formula. This will allow State agencies to issue one can of powder infant formula commonly used in WIC, and is responsive to commenters' requests to make a small amount of infant formula available for partially breastfeeding infants in the first month. The maximum allowances of infant formula for infants 1 month and older in Food Package I and II are retained in this interim rule as proposed. [[Page 68979]] Exhibit A.--Maximum Monthly Allowances for Food Package I for Infants Ages Birth to 6 Months, by Feeding Option -------------------------------------------------------------------------------------------------------------------------------------------------------- Fully breastfed Partially breastfed infants Fully formula fed infants infants --------------------------------------------------------------------------------------------------- WIC food -------------------- 0 through 5 months Birth to one month 1 through 3 months 4 through 5 months 0 through 3 months 4 through 5 months -------------------------------------------------------------------------------------------------------------------------------------------------------- Infant Formula.................. NA................ 104 fl oz 364 fl oz 442 fl oz 806 fl oz 884 fl oz reconstituted reconstituted reconstituted reconstituted reconstituted powder. liquid liquid liquid liquid concentrate\*\. concentrate. concentrate. concentrate. -------------------------------------------------------------------------------------------------------------------------------------------------------- NA= not applicable. \*\ The maximum monthly allowance is specified in the liquid concentrate form; however, powder and RTF are allowable substitutes and the powder form is recommended for partially breastfed infants, ages 0 through 3 months of age. Two technical oversights in the proposed food package rule have been corrected in this interim rule by adjusting the maximum monthly allowance of RTF formula in Food Package I.A. from 800 fluid ounces to 832 fluid ounces, and in Food Package II.A. from 364 fluid ounces to 384 fluid ounces. e. Elimination of Juice for Infants and Addition of Infant Foods in Food Package II A total of 629 commenters (69 form letters) addressed the elimination of juice from the infant food packages. The majority of commenters were in agreement with the provision to eliminate juice from the infant food packages, stating that juice is not nutritionally valuable or necessary for infants. A total of 242 commenters were opposed; 228 of those opposed were program participants. Twelve non- participant commenters stated that the elimination of juice may lead to substitution of lower-cost sweetened beverages. The IOM specifically recommended that infant food fruits and vegetables replace juice for infants 6 through 12 months of age. An important part of the nutrition education provided by WIC staff to parents and caregivers of infant participants' is information on the timing and types of complementary foods appropriate for infants. The addition of jarred infant foods (fruits, vegetables, meat) to Food Package II was well received by commenters. Of the 5,953 commenters that addressed infant foods, 5,887 commenters (of these, 131 were form letters) expressed support for the addition of infant foods. Those that opposed asked that fresh, canned, or frozen fruits and vegetables be allowed in Food Package II instead of, or as an option, to jarred infant foods. Some of these commenters believe that jarred infant foods are environmentally wasteful and costly. Others stated that the provision of jarred foods undermines nutrition education messages about home prepared foods for infants. Some commenters stated that providing a cash value voucher for fruits and vegetables for infants 9-12 months of age may be more developmentally appropriate for this age group. The IOM specifically recommended ``commercial baby food fruits and vegetables and fresh bananas'' for (1) early introduction to new flavors and textures over time; (2) nutrient content; (3) availability in developmentally appropriate textures; and (4) food safety. Further, the provision of commercial baby food fruits and vegetables helps ensure that these items are consumed by infants and not other participants, an important consideration since the amount of infant formula in Food Package II is reduced from current levels and replaced with complementary infant foods. Therefore, the proposed provisions about jarred infant foods in Food Package II are retained in this interim rule. FNS does not believe that the provision of jarred infant foods is incompatible with the nutrition education provided by WIC staff related to appropriate food choices and home preparation of foods for infants since the amount of infant foods provided by WIC is supplemental to an infant's entire needs. (1) Authorized infant meat. A technical oversight in the proposed rule has been corrected in this interim rule by clarifying the minimum requirements and specifications for authorized infant meat as--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. (2) Infant cereal. As proposed, the maximum quantity of infant cereal was not changed from current WIC regulations. Thirteen commenters believe that the amount of infant cereal should be reduced. These commenters stated that in their experience infants did not eat the volume of infant cereal provided by WIC. The IOM recommended that the amount of iron-fortified infant cereal for infants six months and older remain at 24 ounces. Therefore, the proposed maximum amount of infant cereal is retained in this interim rule. f. Rounding Up of Infant Foods Public Law 108-265, the Child Nutrition and WIC Reauthorization Act of 2004, enacted on June 30, 2004, contains a provision that allows a State agency to round up to the next whole can of infant formula to allow all participants to receive the full-authorized nutritional benefit specified by regulation. This provision only applies to infant formula (not exempt infant formula or WIC-eligible medical foods) issued as a result from a solicitation bid on or after October 1, 2004. The proposed rule described the ``full-authorized nutritional benefit'' as well as a methodology that State agencies would be required to use if choosing to implement the option to round up. Consistent with the authority allowing State agencies to round up infant formula, FNS proposed rounding up of infant foods (infant cereal, fruit, vegetables and meat) to provide administrative flexibility to State agencies to ensure that infants would receive the full nutritional benefit recommended by the IOM. Of the 139 comments received on this issue, 129 commenters (66 form letters) disagreed with the proposed methodology for rounding up. Seventy-seven commenters (40 form letters) stated that the proposed methodology was confusing and time-consuming to calculate. Twenty-four commenters (21 form letters) urged FNS to allow State agencies to determine their own methodology for rounding up. FNS is sensitive to commenters' concerns and will further assist State agencies that choose to implement the option to round up. FNS believes, however, that a standard methodology for rounding up, uniformly applied across State agencies, is imperative. Therefore, the [[Page 68980]] rounding up provisions are retained in this interim rule as proposed, except that this interim rule clarifies that the full nutritional benefit for infant formula is provided as a minimum on average during the timeframe that the food package is provided. This means that when the rounding methodology is applied, in some months participants will receive less than the full nutritional benefit amount, and other months will receive more; however, on average, participants will receive the full nutritional benefit. The full nutritional benefit is defined as the maximum monthly allowance of reconstituted fluid ounces of liquid concentrate infant formula for the food package category and feeding option, e.g. partially breastfed infants 4 through 5 months of age. 9. Revisions in Food Package III and Their Effect on Food Packages I and II Under proposed Food Package III, infants with qualifying conditions would be added and other supplemental foods would be authorized. The revisions were intended to provide flexibility in accommodating the wide range of nutritional needs of participants served by this food package, and facilitate the efficient management and tracking of the costs of providing supplemental foods to persons with the most serious medical conditions. Of the 86 comment letters that addressed the proposed revisions to Food Package III, 74 commenters (38 form letters) agreed with the proposed changes, especially the addition of supplemental foods other than WIC formula, cereal and juice that are currently authorized. Twelve commenters (5 form letters) disagreed with the proposed revisions. Commenters remarked on a few specific provisions. While agreeing with the majority of provisions, 21 commenters (19 form letters) from State and local agencies asked that FNS clarify the scope of Food Package III since infants receiving an exempt infant formula for a medical condition would now be served under that package rather than under Food Packages I and II as in current regulations. These same commenters wanted clarification on the qualifying conditions that would allow a participant to receive Food Package III. FNS realizes that serving infants with certain medical conditions under Food Package III rather than under Food Packages I and II will be a major change for WIC staff. As stated in the preamble of the proposed rule, only infant formula would be authorized in Food Packages I and II. Infant formula is a food substitute for human milk for generally healthy, full-term infants. Infant formula includes milk- based, soy-based and lactose-free products. Therefore, infants served under Food Packages I and II will be generally healthy, full-term infants. Conversely, infants with a serious nutritionally-related medical condition that requires an exempt infant formula or WIC- eligible medical food would be served under Food Package III. Women and children with serious medical conditions would also be served under Food Package III. FNS reminds readers that the WIC Works Formula Database, http://www.nal.usda.gov/wicworks provides helpful information on the identification and indications for use of infant formulas, exempt infant formulas and WIC-eligible medical foods. Commenters were also concerned about medically fragile infants 6 months of age or greater whose medical condition prevents them from consuming complementary infant foods. Commenters requested that these infants receive more WIC formula in replacement of the nutrition that would result from the addition of complementary foods. FNS finds merit in this concern and therefore will revise the provision in Table 1 of 7 CFR 246.10(e)(9) to allow medically fragile infants 6 months of age or greater whose medical condition prevents them from consuming complementary infant foods (cereal, fruit and vegetables, and meat) to receive exempt infant formula or WIC-eligible medical foods at the same maximum monthly allowance as infants ages 4 through 5 months of the same feeding option. The provision of exempt infant formula or WIC- eligible medical foods for these infants is in lieu of provision of complementary infant foods. In the proposed rule, FNS requested comments on WIC-eligible medical foods. Of the 36 comments received, 21 commenters (14 form letters) agreed with the WIC-eligible medical food provisions and 15 (all form letters) disagreed. As discussed in section IV.A. of this preamble, commenters disagreed with the proposed definition for WIC- eligible medical foods. Of the 27 commenters (14 form letters) who addressed ways to determine nutritional equivalency for other than liquid forms of ready- to-feed (RTF) medical foods, e.g. bars and puddings, 17 commenters (14 form letters) recommended that protein equivalents be used and 10 commenters felt that the CPA, in consultation with the health care provider, should determine the amount of WIC-eligible medical foods to prescribe, based on a thorough nutritional assessment. One commenter also suggested that FNS consider a serving per day equivalent. FNS has determined that more information is needed about nutritional equivalency for other than liquid RTF forms of WIC-eligible medical foods. FNS will consult with experts from industry as well as the FDA prior to developing guidance for WIC agencies on ways to determine nutritional equivalency for various physical forms of WIC-eligible medical foods. D. Implementation Timeframe for Revised Food Packages FNS proposed a one-year implementation timeframe for the majority of the revisions to the WIC food packages, with the following exceptions--(1) a six-month timeframe was proposed for the elimination of juice for infants; and (2) a limitation was proposed on the ability to implement the partially breastfeeding food packages for infants and women to not more than 32 sites within up to eight selected State agencies so that FNS could examine the effects of the revisions on the initiation and duration of breastfeeding before allowing full implementation by all State agencies. Of the 203 commenters (137 form letters) who addressed the proposed one-year implementation of the revised food package changes for pregnant, postpartum, and fully breastfeeding women, fully formula fed and fully breastfeeding infants, children, and participants with certain medical conditions, 191 commenters (135 form letters) were opposed. Commenters asked for a longer implementation timeframe due to the complexity of the provisions, changes to management information systems, and training needs of staff, vendors and participants. FNS is, therefore, extending the timeframe for implementation of these new food packages to 18 months after the effective date of this interim rule. A total of 611 commenters (501 form letters) addressed the proposed implementation plan for the partially breastfeeding food packages for infants and women. Of these, 590 commenters (501 form letters) were strongly opposed to the plan. Commenters stated that deferring access to these packages denies WIC Programs a vital tool to encourage women to breastfeed and unnecessarily delays participant access to the proposed improvements in these food packages. Commenters also expressed concern that offering both new and old food packages for up to 3 years after implementing the new food packages would create an administrative burden for State agencies and could cause confusion for WIC participants. [[Page 68981]] Finally, commenters pointed out that under the proposed implementation plan, partially breastfed infants 6 months to 11 months old could receive more infant formula than fully formula fed infants. In light of the viewpoints expressed by commenters, and as a result of further review and determination by FNS, the implementation timeframe for the partially breastfeeding food packages for infants and women is revised to be concurrent with implementation of the other food packages--18 months from the effective date of this interim rule. FNS remains committed to examining the impact of the significant changes to these food packages on the breastfeeding mother/infant dyad, and is developing a study design that allows an assessment of the effects of these changes without delaying national implementation. In addition, FNS encourages State WIC agencies to examine the impact of these food package changes in the first month following birth on breastfeeding initiation, intensity and duration and to share the results with FNS and the WIC community. The following chart summarizes the revised implementation timeframes for all food package changes. Timelines for Implementation of Food Package Changes ------------------------------------------------------------------------ Who must Timeframe for Food package category implement implementation ------------------------------------------------------------------------ Pregnant Women................ All State 18 Months from Agencies. Effective Date of Interim Rule. Postpartum Women.............. All State 18 Months from Agencies. Effective Date of Interim Rule. Fully Breastfeeding Women..... All State 18 Months from Agencies. Effective Date of Interim Rule. Partially Breastfeeding Women. All State 18 Months from Agencies. Effective Date of Interim Rule. Fully Formula fed Infants..... All State 18 Months from Agencies. Effective Date of Interim Rule. Partially Breastfed Infants... All State 18 Months from Agencies. Effective Date of Interim Rule. Fully Breastfed Infants....... All State 18 Months from Agencies. Effective Date of Interim Rule. Juice Elimination from Infant All State 18 Months from Food Packages. Agencies. Effective Date of Interim Rule. Children...................... All State 18 Months from Agencies. Effective Date of Interim Rule. Participants with Certain All State 18 Months from Medical Conditions (Women, Agencies. Effective Date of Infants and Children). Interim Rule. ------------------------------------------------------------------------ During the 18-month phase-in period, State agencies are required to issue food benefits based on either the new food packages or current food packages but may not combine the two. For example, a State agency may not add whole wheat bread and fresh fruits and vegetables to the current foods and quantities available under the children's food package. The State agency may, however, phase-in the new food packages on a participant category basis. To minimize participant and vendor confusion, once the State agency begins issuing the new food packages, it must be done on a Statewide basis. FNS will collaborate with the National WIC Association on developing recommendations and options for rolling out the new food packages, based on ease of administration and other issues. State agencies must, however, roll out the food packages for the partially breastfeed mother/infant dyad concurrently, and are also strongly encouraged to concurrently roll out the food packages for the fully breastfed mother/infant dyad. V. Endnotes (1) U.S. Department of Health and Human Services/U.S. Department of Agriculture, Dietary Guidelines for Americans, 2005. Available at Internet site: http://www.healthierus.gov/dietaryguidelines/. (2) Institute of Medicine, National Academy of Sciences. ``WIC Food Packages: Time for a Change,'' 2005. Available at Internet site: http://www.fns.usda.gov/oane/menu/Published/WIC/FILES/Time4AChange (mainrpt).pdf. (3) Institute of Medicine, National Academy of Sciences, 2002a. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: National Academy Press. (4) Environmental Protection Agency/Food and Drug Administration. ``What You Need to Know About Mercury in Fish and Shellfish.'' EPA and FDA Advice for: Women Who Might Become Pregnant, Women Who Are Pregnant, Nursing Mothers, and Young Children. 2004. Available at Internet site: http://www.cfsan.fda.gov/dms/admehg3.html . VI. Procedural Matters Executive Order 12866 This interim rule has been determined to be economically significant and was reviewed by the Office Management and Budget in conformance with Executive Order 12866. Regulatory Impact Analysis 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 interim rule. It follows this regulation as an Appendix. The conclusions of this analysis are summarized below. Need for Action. As the population served by WIC has grown and become more diverse over the last 20 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages have remained largely unchanged. A rule is needed to implement recommended changes to the WIC food packages based on the current nutritional needs of WIC participants and advances in nutrition science. Benefits. Benefits of this rule include bringing the WIC food packages in line with the Dietary Guidelines for Americans\(1)\ and current infant feeding practice guidelines of the American Academy of Pediatrics, better promoting and supporting the establishment of successful long-term breastfeeding, providing WIC participants with a wider variety of food, providing WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences, and serving all participants with certain medical conditions under one food package to facilitate efficient management of medically fragile participants. Costs. FNS estimates that the provisions in this interim rule will have minimal impact on total costs over 5 years. Regulatory Flexibility Act This interim rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C 601-612). Nancy Montanez Johner, Under Secretary, Food, Nutrition and Consumer Services, has certified that this rule will not have a significant economic 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. [[Page 68982]] Although not required by the Regulatory Flexibility Act, FNS has prepared a Regulatory Flexibility Analysis (RFA) describing the impact of this interim rule on small entities. The RFA reflects comments that were received on the Initial Regulatory Flexibility Analysis that was included in the WIC Food Package Proposed Rule published at 71 FR 44784. Additional analysis of the regulatory flexibility considerations of this interim rule may be found in the Regulatory Impact Analysis section of this preamble and the cited RIA itself. Need For, and Objectives of, the Interim Rule This interim rule revises regulations governing the WIC food packages to change the maximum monthly allowances and minimum requirements for certain supplemental foods, and add new foods such as fruits, vegetables and whole grains. The revisions largely reflect recommendations made by the Institute of Medicine of the National Academies in its Report ``WIC Food Packages: Time for a Change.'' \(2)\ These revisions bring the WIC food packages in line with the Dietary Guidelines for Americans\(1)\ and current infant feeding practice guidelines of the American Academy of Pediatrics, better promote and support 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. Description and Estimate of Number of Small Entities To Which the Interim Rule Would Apply This interim 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 and the food industry will realize increased sales of some foods and decreases in other foods, with an overall neutral effect on sales nationally. 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 interim rule, small vendors will be impacted differently in each State depending upon how that State chooses to meet the new requirements. It is, therefore, not feasible to accurately estimate the rule's impact on small vendors. 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 interim rule. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements This interim rule provides State agencies with greater flexibility in prescribing food packages to WIC participants. The information collection burden estimated for this rule is 14,598 hours. The burden reflects requirements associated with medical documentation for the issuance of any supplemental foods issued to participants who receive Food Package III; any authorized soy-based beverage or tofu issued to children who receive Food Package IV; and, any additional authorized tofu and cheese issued to women who receive Food Packages V and VII that exceeds the maximum substitution rate. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered FNS has considered significant alternatives in developing this interim rule including those that may reduce the indirect impact on small business. These considerations include (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 this 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 children up to age five 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. FNS has, however, modified the new food provision in an effort to mitigate the impact on small entities. Currently, 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. This rule adds 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 rule allows canned, frozen and dried fruits and vegetables to be substituted for fresh produce. Federal Rules That May Duplicate, Overlap, or Conflict With the Interim Rule There are no Federal rules that may duplicate, overlap, or conflict with the provisions of this interim rule. Public Law 104-4, Unfunded Mandates Reform Act of 1995 (UMRA) Title II of the UMRA 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, FNS generally must prepare a written statement, including a cost/ benefit analysis, for proposed and final rules with ``Federal mandates'' that may result in expenditures to State, local, or tribal governments, in the aggregate, or to 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 FNS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule. This interim rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) that impose costs on State, local, or tribal governments or to the private sector of $100 million or more in any one year. This rule is, therefore, not subject to the requirements of sections 202 and 205 of the UMRA. Executive Order 12372 The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) is listed in the Catalog of Federal Domestic Assistance under [[Page 68983]] No. 10.557. For reasons set forth in the final rule in 7 CFR part 3015, Subpart V and related Notice (48 FR 29114, 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 13132. Prior Consultation With WIC State and Local Agency Officials Over the years FNS has received numerous requests from WIC State and local agencies to modify the current food packages to permit greater substitution of foods or introduction of additional foods. These requests have come from formal and informal discussions and with State and local officials on an ongoing basis regarding program implementation and food package policy issues, and from written proposals and comments submitted to FNS by WIC State and local agencies to allow modifications and/or substitutions to the WIC food packages. Requests for revisions to the WIC food packages have also been received from Congress, participants, and organizations with interests in the welfare of WIC participants. Examples of the different forums and methods FNS has used over the years to solicit WIC State