[Federal Register: August 7, 2006 (Volume 71, Number 151)] [Proposed Rules] [Page 44783-44855] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07au06-17] [[Page 44783]] ----------------------------------------------------------------------- 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; Proposed Rule [[Page 44784]] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 246 RIN 0584-AD77 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages AGENCY: Food and Nutrition Service (FNS), USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: This proposed rule would revise regulations governing the WIC food packages to align the WIC food packages with the 2005 Dietary Guidelines for Americans 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, provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences, and serve participants with certain qualifying conditions under one food package to facilitate efficient management of medically fragile participants. 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,'' with certain cost containment and administrative modifications found necessary by the Department to ensure cost neutrality. The proposed improvements to the WIC food packages can be made without increasing the projected costs. The proposed rule would revise the maximum monthly allowances and minimum requirements for certain supplemental foods; revise the substitution rates for certain supplemental foods and allow additional foods as alternatives; redesign WIC food packages to enhance breastfeeding promotion and support; revise age specifications for assignment to infant food packages; add fruits and vegetables for WIC participants 6 months of age and older and eliminate juice from infants food packages; add whole grains to food packages for children and women and infant food meat for fully breastfed infants 6 through 11 months of age; revise the purpose, content, and requirements for the Food Package for the Medically Fragile, and address general provisions that apply to all food packages. DATES: To be assured of consideration, comments must be postmarked on or before November 6, 2006. ADDRESSES: The Food and Nutrition Service invites interested persons to submit comments on this proposed rule. Comments may be submitted by any of the following methods: 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. Web site: Go to http://www.fns.usda.gov/wic. Follow the online instructions for submitting comments through the link at the Supplemental Food Programs Division Web site. E-mail: Send comments to WICHQ-SFPD@fns.usda.gov. Include ``Docket ID Number 0584-AD77, WIC Food Packages Rule,'' in the subject line of the message. Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting comments. All comments submitted in response to this proposed 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. All written submissions will be available for public inspection at the address above during regular business hours (8:30 a.m. to 5 p.m.) Monday through Friday. FNS may also make the comments publicly available by posting a copy of all comments on the FNS Web site at 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, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 528, Alexandria, Virginia 22302, (703) 305-2746, OR Debbie.Whitford@fns.usda.gov. A copy of the National Academies' Institute of Medicine report, ``WIC Food Packages: Time for a Change,'' which provides the scientific backdrop for this proposed rule, is available on the FNS Web site at http://www.fns.usda.gov/oane/menu/Published/WIC/FILES/Time4AChange (mainrpt).pdf. SUPPLEMENTARY INFORMATION: I. Overview This proposed rule would implement 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. The proposal is based on the recommendations of the National Academies' Institute of Medicine (IOM), which was commissioned by FNS in September 2003, to independently review the WIC food packages. The IOM used current scientific information to assess the nutrient adequacy of the diets of WIC participants; assess the supplemental nutrition needs of the population served by WIC; look at the nutrient contributions of the current packages; propose priority nutrients and general nutrition recommendations; and make recommendations for specific changes to the WIC food packages. The IOM used various data sources including the 2005 Dietary Guidelines for Americans, the Dietary Reference Intakes, WIC participant data, food consumption and intake data (Continuing Survey of Food Intakes by Individuals (CSFII); National Health and Nutrition Examination Survey (NHANES)) and examined nutrition-related health risks to identify nutrients and food groups to try to increase or decrease in the food packages with the goal of improving the nutrition of WIC participants. The review of the WIC food packages was further informed by extensive comments made in response to an Advanced Notice of Proposed Rulemaking on revisions to the WIC food packages and by comments received by the IOM in public forums during its review. Compared to current WIC packages, the proposal: Provides greater consistency with the Dietary Guidelines for Americans. The proposal adds fruits and vegetables, and whole grains to the packages for the first time. The revised packages include foods from each food group except oils and allow variety and choice within the groups. Reductions are made to the amounts provided for certain foods in the current packages in order to be more consistent with the amounts of these foods recommended in the 2005 Dietary Guidelines for Americans and WIC's role as a supplemental nutrition program. Supports improved nutrient intakes. The proposed additional foods and modified amounts of current foods support overall improvement in nutrient consumption and reduction in the [[Page 44785]] prevalence of inadequate or excessive nutrient intakes. Compared with the current food packages, the revised packages are estimated to provide greater amounts of nearly all the nutrients of concern with regard to inadequate intake identified by the IOM such as iron, fiber, and vitamin E. The revised food packages for women and children also provide less saturated fat, cholesterol, total fat and sodium than the current packages. Provides greater consistency with established dietary recommendations for infants and children under 2, including encouragement and support for breastfeeding. The revised infant food packages improve overall nutrient density compared to current packages while keeping caloric content the same or slightly lower. The revised packages change age specification for assignment as well as establish three feeding categories to better address current dietary recommendations of the American Academy of Pediatrics (AAP) and promote breastfeeding. The packages for breastfeeding infant-mother pairs are revised to provide stronger incentives for continued breastfeeding, including providing less formula to partially breastfed infants than current packages, and providing additional quantities/types of food for breastfeeding mothers. For older infants, the proposal delays the introduction of complementary foods, consistent with AAP, from four to six months of age and modifies formula amounts. Infant foods are added and juice eliminated in the packages for older infants in order to promote healthy dietary patterns. Addresses emerging public health nutrition-related issues. The prevalences of overweight and obesity in adults, adolescents, and children have increased dramatically, with direct implications for WIC participants. For example, childhood overweight has been linked to adverse health outcomes including elevated blood pressure, hyperinsulinemia, glucose intolerance, type 2 diabetes, dyslipidemia, and other early risks for chronic disease. The addition of fruits and vegetables and the emphasis on whole grains are consistent with recommendations for food patterns that may contribute to a health body weight. Compared to the current food packages, the revised food packages provide less saturated fat and cholesterol than the current packages for women and children. In addition, the revised food packages are designed to encourage breastfeeding and thus may contribute to a reduced risk of overweight in children. Reinforces the nutrition education messages provided to participants. The proposed food package more closely mirrors the 2005 Dietary Guidelines for Americans and dietary recommendations for infants and children under two and is more consistent with the nutrition education provided to participants. Provides wide appeal to diverse populations. The proposed additional foods are the foods most often requested over the years by a variety of stakeholders such as the National WIC Association, WIC participants, WIC State and local agencies, industry and health professionals, and would provide more participant choice and a wider variety of foods than the current food packages. The increased variety and choice will provide State agencies increased flexibility in prescribing culturally appropriate food packages. 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 Department 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 to continue healthful dietary practices after leaving the Program. Since the creation of the WIC Program in the 1970's, 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. A. Advanced Notice of Proposed Rulemaking (ANPRM) On September 15, 2003, FNS published an ANPRM at 68 FR 53903 seeking comments on revisions to the food packages offered through the WIC Program. FNS solicited public comments to determine if the WIC food packages should be revised to better improve the nutritional intake, health and development of participants and, if so, what specific changes should be made to the food packages. In response to this ANPRM, the Department received 195 letters. Respondents represented the general public, State and local WIC agencies, the National WIC Association (NWA), State WIC associations, industry, independent health professionals, vendors, WIC participants, and others. Comments received from NWA included two published position papers \(1, 2)\ that provided recommendations based on that organization's analysis of the needs of WIC participants. B. Review of the WIC Food Packages by the Institute of Medicine In September 2003, FNS contracted with the National Academies' Institute of Medicine (IOM) to independently review the WIC Food Packages in a 22-month study. FNS charged the IOM with reviewing the nutritional needs of the WIC population, and recommending changes to the WIC food packages. Recommendations were to be cost- [[Page 44786]] neutral, efficient for nationwide distribution and vendor checkout, non-burdensome to administration, and culturally suitable. FNS asked IOM to consider the supplemental nature of the WIC Program, burdens/ incentives for eligible families, the role of WIC food packages in reinforcing nutrition education, breastfeeding, and chronic disease prevention, and public comments received from FNS' ANPRM. Under this contract, IOM selected a Committee of experts in nutrition, health, risk assessment and economics to conduct this study in two phases. During Phase I, the committee developed the following criteria to guide its work. It also used various data sources to identify nutrients and food groups to try to increase or decrease in the food packages (i.e., priority nutrients and priority food groups), with the goal of improving the nutrition of WIC participants. ------------------------------------------------------------------------ ------------------------------------------------------------------------- Criteria for a WIC Food Package FROM: ``WIC Food Packages; Time For A Change.'' The Institute of Medicine of the National Academies, The National Academies Press, 2005, page 37 ------------------------------------------------------------------------ 1. The package reduces the prevalences of inadequate and excessive nutrient intakes in participants. 2. The package contributes to an overall dietary pattern that is consistent with the Dietary Guidelines for Americans, for individuals two years of age and older. 3. The package contributes to an overall diet that is consistent with established dietary recommendations for infants and children less than two years of age, including encouragement of and support for breastfeeding. 4. Foods in the package are available in forms suitable for low-income persons who may have limited transportation, storage, and cooking facilities. 5. Foods in the package are readily acceptable, widely available, and commonly consumed; take into account cultural food preferences; and provide incentives for families to participate in the WIC program. 6. Foods will be proposed giving consideration to the impacts that changes in the package will have on vendors and WIC agencies. ------------------------------------------------------------------------ In Phase II, the Committee used these criteria and its review of the nutritional needs of WIC participants to develop recommendations for changing the WIC food packages. The IOM published these recommendations in a report, ``WIC Food Packages: Time for a Change'' (IOM Report), which was released on April 27, 2005). (3). C. Cost Neutrality Since the WIC Program receives a finite amount of funding annually to serve as many participants as this funding allows, 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. The IOM conducted a cost analysis as part of its review and believes that its recommendations to revise the WIC food packages were relatively cost-neutral, given data available to the IOM at that time. However, based on updated data, the Department now estimates that implementing the IOM's recommendations in full would cost $1.3 billion above the cost-neutral level over 5 years. Therefore, the Department has modified two of the IOM's recommendations to achieve a cost neutral proposal consistent with statutory requirements. The Department carefully considered which of the IOM recommendations to modify to achieve cost neutrality, basing the decision on 3 criteria--relative cost, nutritional impact, and overall context of the IOM recommendations. To achieve cost neutrality, the Department is proposing a cash-value fruit and vegetable voucher that is $2 less per month than that recommended by the IOM, and is not proposing yogurt as an authorized alternative to milk. The price of yogurt as compared to the price of milk would considerably increase the monthly cost of the food packages for children and women. Soy beverage and tofu also have higher per unit costs than milk; however, the estimated amount of tofu that would be purchased by WIC participants is substantially lower than that of yogurt. Soy beverage can serve as an alternative for all or part of the fluid milk for adult women, making it a more cost-effective substitute. 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 $2 reduction in the cash- value fruit and vegetable voucher fulfills this intent while ensuring cost neutrality. The Department believes that this proposed rule largely sets forth the scope of the IOM recommendations notwithstanding these necessary modifications. Commenters are encouraged to suggest alternative ways to achieve cost neutrality within the context of the overall IOM recommendations. State agencies will be responsible for determining how to fully implement the proposed provisions within their grants. Options available to State agencies include applying judicious use of currently authorized caseload management procedures, including the participant priority system in accordance with Sec. 246.7(e)(4) of WIC regulations, or by implementing other cost containment measures. State agencies are also reminded that Sec. 246.16a(g) authorizes State agencies to implement a cost containment system for any WIC food other than infant formula. D. Stakeholder Comments The comments FNS received from its ANPRM represented a wide range of perspectives. A majority of those who commented expressed general support for foods currently offered, but also proposed at least one change. Nearly three-fourths of those responding to FNS stated that fruits and vegetables should be added to the packages. Other comments addressed topics including priority nutrients, design and structure of the food package, amount of juice, amount of milk, choices of milk products, alternative sources of calcium, cereal and grain choices, physical forms of legumes (i.e., dried or canned beans or peas), peanut butter, eggs, tuna, alternative sources of protein, infant formula, medical foods regulations, cost, incentives to breastfeed, flexibility at the State agency level, and more variety and choice at the participant level. Comments may be viewed at http://www.fns.usda.gov / wic/lawsandregulations /revfoodpkg-anprm.htm#publiccomments. Similar themes were addressed in over 70 written and 30 oral public comments submitted directly to the IOM committee during its 22-month review of the WIC food packages. E. Legislative Requirements Sections 17(a) and (b)(14) of the Child Nutrition Act of 1966, as amended, (CNA) (42 U.S.C. 1786(a) and (b)(14)) clearly established the WIC Program as [[Page 44787]] ``supplemental'' in nature; that is, the WIC supplemental foods are not intended to provide a complete diet but are designed to provide nutrients determined by nutritional research to be lacking in the diets of the WIC population. The law also directs the Secretary in Section 17(f)(11) of the CNA (42 U.S.C. 1786(f)(11)) to assure that, to the degree possible, the fat, sugar, and salt content of supplemental foods is appropriate. Section 203(a)(2) of Public Law 108-265 amended Section 17(b)(14) of the CNA by revising the definition of supplemental foods to include foods that promote health as indicated by relevant nutrition science, public health concerns, and cultural eating patterns. Early legislation for the WIC Program, Public Law 92-433 (1972) through Public Law 94-105 (1975), specifically identified protein, iron, calcium and vitamins A and C as nutrients of particular concern for WIC participants. Public Law 95-627, enacted in November 1976, deleted reference to specific nutrients; however, the Department retained high-quality protein, iron, calcium, and vitamins A and C as the targeted nutrients in the WIC Program. F. Current WIC Food Packages WIC food package requirements appear in Sec. 246.10 of the WIC Program regulations. The last major revision of the WIC Food Packages was in 1980 (45 FR 74854, November 12, 1980). The 1980 rule established six different monthly packages--Food Package I for infants 0-3 months; Food Package II for infants 4-12 months; Food Package III for children and women with special dietary needs; Food Package IV for children 1-5 years of age; Food Package V for pregnant and breastfeeding women; and Food Package VI for nonbreastfeeding postpartum women. The Department created an additional food package in 1992 (57 FR 56231, November 27, 1992). This enhanced food package, Food Package VII, was designed for breastfeeding women who elect not to receive infant formula through WIC for their infants. Current WIC supplemental foods include iron-fortified infant formula, iron-fortified cereals, vitamin C-rich 100 percent fruit and/ or vegetable juice, calcium/protein-rich milk and cheese, protein/iron- rich eggs, protein-rich peanut butter or dried beans/peas, and physician-prescribed formula/medical foods for participants with certain special dietary needs. The enhanced package for breastfeeding women increases allowable amounts of juice, cheese, peanut butter and dry beans/peas, and also allows protein-rich tuna fish and carrots that provide beta-carotene (precursor to vitamin A) and dietary fiber. G. New Nutrient Recommendations Over the past decade, knowledge of nutrient requirements has increased substantially, resulting in a set of new dietary reference values called the Dietary Reference Intakes (DRIs).(4-9) The DRIs replace the 1989 Recommended Dietary Allowances (RDAs) as nutrient reference values for the United States population. Based on the DRIs, many of the recommendations for nutrient intakes for individuals (RDAs) have changed substantially since the WIC food packages were originally formulated. Although basic concepts of nutrition have not changed, there has been a substantial increase in knowledge of specific concepts such as bioavailability, nutrient-nutrient interactions, and the distribution of dietary intake of nutrients across subgroups of the population. In addition to recommended intakes, the DRIs include appropriate standards to use in determining whether diets are nutritionally adequate without being excessive. The DRIs encompass more aspects of nutrition that did the earlier RDAs, as follows: DRIs consider reduction in the risk of chronic disease, as well as the absence of signs of deficiency. For most nutrients, DRIs include both RDA and Estimated Average Requirement (EAR) values. For some nutrients, insufficient data were available to set EAR and RDA values. For these nutrients, Adequate Intake (AI) values were estimated. DRIs include Tolerable Upper Intake Levels (ULs), which are used in the evaluation of the risk of adverse effects from excess consumption. DRIs specify appropriate ranges of macronutrient densities, which are called Acceptable Macronutrient Distribution Ranges (AMDRs). When adequate data are available, DRIs provide reference values for food components other than nutrients. Assessing nutrient adequacy involves determining the extent to which the diets of WIC-income-eligible subgroups meet nutrient requirements without being excessive. In its Report, the IOM conducted analyses applying the DRIs and the recommended methods to assess the nutrient adequacy of the diets of WIC participants. III. Priority Nutrients, Nutrition-Related Health Priorities, and Priority Food Groups Cited by the IOM Report (3) The IOM Report cites fundamental changes that have occurred in the major health and nutrition risks faced by WIC's target population. The prevalences of underweight and iron-deficiency anemia have decreased. Diets have improved in many respects, and nutrients for which intakes often appeared to be low in the 1970s (calcium and vitamins A and C) are less problematic, particularly for children. Despite improved access to health care and health services, the prevalences of overweight and obesity in adults, adolescents, and children have increased dramatically, regardless of WIC participation. In addition, marked demographic changes have occurred, with both a dramatic increase in the number of persons served by WIC and a substantial shift in the ethnic composition of the WIC population. Hispanics now make up the largest share of WIC participants.(10) A. Priority Nutrients IOM designated a nutrient as a priority nutrient if the prevalence of dietary inadequacy was non-trivial, or the mean intake is below the AI, or there is a recognized nutrition-related health priority (e.g., observable levels of iron deficiency anemia). The methodology used to identify nutrients at high risk of inadequacy is described by the IOM in ``Dietary Reference Intakes: Applications in Dietary Assessment.'' (11) Based on detailed analyses,\1\ the IOM Report cites the [[Page 44788]] following nutrients as high priority for WIC participants. --------------------------------------------------------------------------- \1\ The IOM analyzed nutrient intake using nationally representative data for WIC children and for non-breastfed WIC infants. However, the IOM found that for breastfed infants 6 through 11 months of age, and for the women's groups, the nationally representative data did not provide adequate sample size of WIC participants for meaningful analysis. Consequently, the IOM used data for all infants 6 through 11 months and for all pregnant and lactating women. For non-breastfeeding postpartum women categorically eligible for WIC (up to six months postpartum), the IOM used data for all women within one year postpartum. The Department would have preferred to have adequate sample size to limit all of these analyses to the WIC actual groups, so that the recommendations could be completely tailored to the WIC population. Prior research using data from the Continuing Survey of Food Intakes by Individuals indicates that there are statistically significant differences in dietary intake between low income and higher income adults. For example, when controlling for a wide variety of independent factors, those adults with incomes below 130 percent of poverty have statistically lower usual mean intakes for food energy and almost all vitamins and minerals, and were less likely to meet either 70 percent or 100 percent of the RDA. (See Gleason P., A. Rangarajan and C. Olson. ``Dietary Intake and Dietary Attitudes Among Food Stamp Participants and Other Low-Income Individuals,'' United States Department of Agriculture, Food and Nutrition Service, Office of Analysis, Nutrition and Evaluation FSP-00-DI, Project Officer Sharron Cristofar, Alexandria, Virginia 2002.) However, the pattern of which nutrients more frequently have low intakes is very similar for the high- and low-income groups. For example, among the nine vitamins and five minerals studied, both the list and order of the six nutrients with the smallest portion of the population consuming 70% of the RDA is the same for the low- and high-income groups. Estimates based on too small a sample have an unacceptably high risk of inaccurately representing the true population mean and distribution. Therefore, for the purpose of comparing nutrient adequacy and excesses among a group of nutrients when the WIC sample is limited, use of the all-income sample is the best available alternative. --------------------------------------------------------------------------- WIC infants under one year of age, non-breastfed: No nutrients were identified with a high risk of inadequacy. Priority nutrients related to risk of excessive intakes in non-breastfed infants are zinc, preformed vitamin A, and food energy (calories). Breastfed infants 6 through 11 months: Priority nutrients identified as lacking in the diets of breastfed infants six months and older are iron and zinc. WIC children 1 through 4 years of age: Priority nutrients identified as lacking in the diets of young children are vitamin E, fiber, and potassium, and iron. Nutrients that may be excessive in the diets of young children are zinc, preformed vitamin A, sodium, food energy (calories), and saturated fat. Pregnant, lactating, and non-breastfeeding postpartum women: Priority nutrients identified as lacking are calcium, iron, magnesium, vitamin E, potassium, and fiber. Nutrients with moderate, but still high, levels of inadequacy are vitamins A, C, and B6, and folate. Nutrients with lower levels of inadequacy are iron, zinc, thiamin, niacin, and protein. Sodium intakes and saturated fat intakes as a percentage of food energy intakes are excessive in the diets of pregnant, lactating, and non-breastfeeding postpartum women. B. Nutrition-Related Health Priorities In addition to analyses of nutrient adequacy, the IOM reviewed epidemiological evidence on body weight status, micronutrients of special concern during reproduction and early childhood, food allergies, and selected environmental risks to the health of women, infants, and children. Several concerns were identified by the IOM for all WIC subgroups--obesity, poor iron status, and contamination of food with dioxin and methylmercury. The IOM also determined that low folate intake is a concern for all women during their reproductive years because of its importance in preventing neural tube defects; insufficient calcium intake for pregnant and breastfeeding women may be associated with potential lead toxicity for the fetus and infant; low intake of vitamin D is a potential concern for women of reproductive age because of its importance in bone health; and inadequate zinc intake is a concern for breastfed infants 6 through 11 months of age because human milk does not provide recommended amounts of zinc for older infants. C. Priority Food Groups To determine whether specific foods or types of food should receive priority in the re-design of WIC food packages, the IOM reviewed information about dietary guidance, amounts of foods consumed by groups that potentially are eligible for the WIC Program, and the amounts of foods in current WIC food packages. The IOM's assessment gave major consideration to the Dietary Guidelines for Americans (DGA), which form the basis of Federal food and nutrition programs (Pub. L. 101-445, U.S. Congress, 1990). To do this, the IOM used the DGA 2005 (12) as the source of dietary guidance for children ages two years and older and widely accepted dietary guidance from professional groups, such as the American Academy of Pediatrics, for children under two years of age. The IOM Report cites the following concerns: 1. Children ages 2 through 4 years and women in the childbearing years: Overall: Intakes of whole grains, vegetable subgroups excluding potatoes and other starchy vegetables, fruits, milk and milk products, and meats are all lower than recommended on average; Children ages 2 through 4: Intakes tend to be low in whole grains and in dark green leafy vegetables, deep yellow vegetables, cooked dry beans and peas rather than vegetables in general; and Women: Intakes tend to be low in whole grains, dark green leafy vegetables, deep yellow vegetables, cooked dry beans and peas, and fruit and milk groups. 2. Infants and children younger than 2 years of age: Dietary practices of most concern to the IOM include the short duration of breastfeeding, excessive consumption of fruit juice, early introduction of solid food and cow's milk, low consumption of fruits (other than juice) and vegetables, and infrequent exposure to new foods. Exhibit A in this preamble, from the IOM Report,(3) summarizes nutrient and food group priorities that form the basis for the proposed revisions of the WIC food packages. Exhibit A.--Nutrient and Food Group Priorities for Proposed Revised WIC Food Packages [FROM ``WIC Food Packages; Time For A Change.'' The Institute of Medicine of the National Academies, The National Academies Press, 2005, page 72] ---------------------------------------------------------------------------------------------------------------- Nutrients of Nutrients of concern with Priority food concern with Nutrients and Participant category regard to groups regard to ingredients to inadequate intake excessive intake limit in the diet ---------------------------------------------------------------------------------------------------------------- Infants, less than 1 y, non- No need identified na................ Decrease intakes breastfed. to increase of Zinc, Vitamin particular A, preformed,b nutrients; and Food energy. maintain iron intakes and continue to provide a balanced set of essential nutrients.a. Infants, 6-11.9 mo, breastfed... Increase intakes na................ of Iron and Zinc. Children, 12-23.9 mo............ Increase intakes Increase intakes Decrease intakes of Iron, of a variety of of Zinc, Vitamin Potassium, non-starchy A, preformed, b Vitamin E, and vegetables. and Food energy. Fiber. [[Page 44789]] Children, 2-4.9 y............... Increase intakes Increase intakes Decrease intakes Limit intakes of of Iron, of whole grains, of Zinc, Sodium, Saturated fat, Potassium, and a variety of Vitamin A, Cholesterol, and Vitamin E, and non-starchy preformed,b and Added sugars. Fiber. vegetables. Food energy. Adolescent and adult women of Give highest Increase intakes Decrease intakes reproductive age. priority to of whole grains, of Sodium, Food increasing a variety of non- energy, and Total intakes of starchy fat . Calcium, Iron, vegetables, Magnesium, fruit, and fat- Potassium, reduced milk Vitamin E, and products. Fiber. Also try to increase intakes of Vitamin A, Vitamin C, Vitamin D, Vitamin B6, and Folate]. ---------------------------------------------------------------------------------------------------------------- Note: na = not applicable; UL = Tolerable Upper Intake Level. a Iron intakes are apparently adequate for non-breastfed infants, probably due in part to provision of iron- fortified formula in the current WIC food packages. b The UL applies only to preformed vitamin A (i.e., retinol) ingested from the combined sources of animal- derived foods, fortified foods, and dietary supplements.(13) c Trans fatty acids have not specifically been identified as a hazard for infants and children, and thus are shown in the table as nutrients to limit only in the diets of adolescents and adults.(8) However, the dietary guidance to limit trans fatty acids from processed foods in the diet is presumed to apply to all individuals regardless of age. D. Identifying Foods To Reduce or Eliminate Exhibit B in this preamble reflects the IOM's recommendations and rationale regarding foods in the current WIC food packages to be deleted or reduced in the proposed revised food packages. Exhibit B.--Foods in the Current WIC Food Packages To Be Deleted or Reduced in the Proposed Food Packages [FROM ``WIC Food Packages; Time For A Change.'' The Institute of Medicine of the National Academies, The National Academies Press, 2005, page 82] ---------------------------------------------------------------------------------------------------------------- Food Change Rationale ---------------------------------------------------------------------------------------------------------------- Infant formula........................ Reduce maximum amounts for The maximum amount provides partially breastfed infants. approximately half the amount provided to fully formula fed infants to encourage the mother to breastfeed enough to provide at least half of the infant's nutritional needs and to make possible other improvements in the WIC food packages. Infant formula........................ Reduce maximum amounts for Since the food package for infants of fully formula fed infants this age provides greater amounts of ages 6-11.9 mo of age. nutrients through complementary foods, less formula is needed. Juice................................. Delete juice for infants 4- Meet AAP recommendations to delay 11.9 mo of age; reduce amount introduction of juice for infants until of juice for children 1-4.9 y after 6 mo of age; allow no more than 4- of age. 6 fl oz/day for infants above the age of 6 mo.\(14)\ For infants age 6-11.9 mo, fruit juice has no nutritional benefit over whole fruit.\(15)\ Milk.................................. Decrease maximum amounts Amounts provided need not exceed amounts allowed for children and recommended by DGA 2005.\(12)\ adults. Cheese................................ Reduce maximum amount allowed Meets recommendation from DGA 2005 in women's and children's \(12)\ and recommendation from the IOM packages. to reduce saturated fat and cholesterol intake.\(8)\ Eggs.................................. Reduce maximum amount allowed. Protein is no longer a priority nutrient. Reduction in amount provided is consistent with DGA 2005 \(12)\ and with recommendation from the IOM to reduce cholesterol intake.\(8)\ ---------------------------------------------------------------------------------------------------------------- Note: AAP = American Academy of Pediatrics; IOM = Institute of Medicine. The full context of IOM's recommendations, including analyses, can be found in its report ``WIC Food Packages: Time for a Change'' \(3)\ available at http://www.fns.usda.gov/oane/menu/Published/WIC/WIC.htm. E. The IOM's Recommendations in the Context of this Proposed Rule The IOM Report considered current recommendations for nutrient intakes and dietary patterns, the major diet-related health problems and risks faced by WIC's target population, the characteristics of the WIC Program, and the diversity of its participants. IOM's recommendations are intended to make the WIC food packages better meet the supplemental nutrition needs of participants and be more consistent [[Page 44790]] with national and professional dietary guidance and more consistent with nutrition education messages that promote healthful diets for the WIC population. The IOM Report has provided FNS with a sound scientific basis for proposing a new set of food packages for the WIC Program. Except for certain cost containment and administrative modifications found necessary by the Department to ensure cost neutrality, FNS is largely setting forth IOM's recommendations in this proposed rule for public comment. However, FNS is aware that these proposed revisions represent substantial changes for the WIC Program, its participants, and authorized vendors. Implementation procedures, staff and vendor training, and the nature of the nutrition education provided are likely to influence the effectiveness of the proposed revised food packages. Commenters are encouraged to provide input that would assist FNS in assessing the training and technical assistance needs of WIC State agencies and WIC-authorized vendors in implementing these proposed changes. IV. Re-Design of WIC Food Packages To Enhance Breastfeeding Promotion and Support A. Current Breastfeeding Promotion and Support in WIC WIC has historically promoted breastfeeding to all pregnant women as the optimal infant feeding choice, unless medically contraindicated. Current federal WIC regulations (Sec. Sec. 246.7(e)(1)(iii), 246.7(g)(1)(iii), 246.10(c)(7), and 246.11(c)) contain provisions to encourage women to breastfeed and to provide appropriate nutritional support for breastfeeding participants, including: Information provided to WIC mothers choosing to breastfeed through counseling and breastfeeding educational materials; Follow-up support through peer counselors; Eligibility to participate in WIC longer than non- breastfeeding mothers; Enhanced food package for mothers who exclusively breastfeed their infants; and Breast pumps, breast shells or supplemental nursing systems to help support the initiation and continuation of breastfeeding. In part as a result of strengthened WIC breastfeeding policy and program activities in the early 1990's, WIC breastfeeding rates have increased at a faster rate than in the non-WIC population in the United States in the last decade. Despite these gains, WIC participants lag behind the general population in progress toward meeting the breastfeeding objectives of Healthy People 2010.(16) B. The IOM's Recommendations To Promote and Support Breastfeeding Via the WIC Food Packages As described in the IOM Report, the proposed revised food packages for infants and women are 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. Breastfeeding is the preferred method of infant feeding because of the nutritional value and health benefits of human milk.(15, 16, 17) The IOM's three-pronged approach to better promote and support breastfeeding through the WIC food packages is proposed. The proposed 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. Proposed changes to help support breastfeeding address packages for the infant as well as the mother since both are eligible to receive a WIC food package. According to the IOM, the perceived dollar value, from the mother's point of view, of the current food packages provided for formula-feeding infant-mother pairs is substantially larger than that of the packages for the fully breastfeeding pairs, especially during the first six months postpartum. The IOM believes that attractive packages for fully breastfeeding mother/infant pairs might act as an incentive for breastfeeding. The proposed revised food packages increase the value of the contents of the food packages for the fully breastfeeding mother/infant pairs while decreasing the relative value to mothers of the food packages for partially breastfeeding pairs and fully formula-feeding pairs. As described by the IOM, the differences in the proposed packages for the mother-infant pairs are 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 includes commercial infant food meats to add a source of iron and zinc. 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. These proposed food package changes, as recommended by the IOM, are intended to strengthen WIC's efforts to promote and support breastfeeding as the optimal infant feeding choice for WIC mothers. V. Proposed Revisions to the WIC Food Packages A. Use of Terms For the purposes of discussion, this proposed rule uses the following terms. WIC food categories refers to WIC formula (infant formula, exempt infant formula and WIC-eligible medical foods); milk and milk alternatives; eggs; peanut butter; legumes (dried beans and peas); infant cereal; breakfast cereal; canned fish; whole wheat bread or other whole grains; infant fruits and vegetables; infant meat; cheese; juice; and fruits and vegetables. Food type refers to specific foods within a category, e.g., skim milk and soy-based beverages are types of food in the milk and milk alternatives category. Physical form refers to the way in which the food is manufactured and/or packaged, e.g., dried, frozen; fresh; powder; liquid concentrate; fluid; evaporated, canned. B. Revised Food Packages I and II for Infants As recommended by the IOM, this rule proposes the following changes in Food Packages I and II for infants (currently Sec. 246.10(c)(1) and (c)(2)). Revise age specifications for assignment to infant food packages; 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; [[Page 44791]] 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 revised 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, as recommended by the IOM, are 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. 1. Reassignment of Infants With Qualifying Conditions to Food Package III Medically fragile infants currently receive either Food Package I (Sec. 246.10(c)(1)) for infants 0-3 months of age or Food Package II (Sec. 246.10(c)(2)) for infants 4-12 months of age. The WIC formulas authorized for issuance to infants in Food Packages I and II include infant formula, exempt infant formula and WIC-eligible medical foods. This rule proposes to revise Sec. 246.10(c)(1) through (c)(3) of Program regulations for Food Packages I, II and III in order to develop a restructured Food Package III that would serve all categories of participants, including infants, who have certain diagnosed qualifying conditions. The revised title for this food package would be Food Package III--Participants with Qualifying Conditions. The rationale for including infants in Food Package III is to consolidate all medically fragile individuals with qualifying conditions into one package to facilitate efficient management and tracking of the benefits and costs of providing supplemental foods to these participants. Refer to section V.P. of this preamble, Revisions to Food Package III and their effect on Food Packages I and II, for further information. 2. Change in Age Specifications for Assignment to Food Packages I and II As recommended by the IOM, this proposed rule would revise Food Package I to serve infants from birth through age 5 months and revise Food Package II to serve infants ages 6 months through 11 months. Currently, the assignment to Food Package II occurs at age four months. 3. Establishment of Infant Feeding Options a. First Month After Birth. To support the successful establishment of breastfeeding, the proposed rule, as recommended by the IOM, would establish two infant feeding options for the first month after birth, either full breastfeeding or full formula-feeding. That is, formula would not be provided for fully or partially breastfeeding infants during the first month after birth. If a breastfeeding mother requests formula during the first month, the Department would advise WIC staff to continue to provide breastfeeding support for the mother, with special attention to the provision of peer counseling, breast pumps, consultation with lactation experts, and referrals to medical providers when appropriate. Anticipatory guidance for new mothers during the prenatal period would be important for the success of this approach. As is currently the case, the breastfeeding mother could ask to have the infant assigned to full formula feeding option at any time and WIC staff would reassign the infant's and the mother's food package accordingly. b. Second Month After Birth Through Month Eleven. Beginning the second month after birth, a third infant feeding option is proposed-- partial breastfeeding. As recommended by the IOM, this rule proposes that, for the purposes of assigning WIC food packages, a partially breastfed infant be defined as an infant who is breastfed but also receives formula from the WIC Program in an amount not to exceed approximately half the amount of formula allowed for a fully formula fed infant. Currently, there is not a food package for partially breastfed infants. Instead, breastfeeding infants may receive up to the maximum amount of infant formula authorized in Food Packages I and II. State agencies are currently encouraged to tailor the amount of infant formula provided based on the assessed needs of the breastfeeding infant. Under this proposal, breastfeeding mothers who request more than the amount of formula allowed for partially breastfed infants could receive up to the maximum amount of formula for the fully formula fed infant. In such instances, the infant's feeding option would be changed from partially breastfed to fully formula fed and the mother's food package adjusted accordingly. 4. Introduction of Complementary Foods at 6 Months of Age As recommended by the IOM, the proposed Food Package I would provide only iron-fortified infant formula for partially breastfed and fully formula fed infants until an infant is six months old. As cited by the IOM, this change is consistent with recent position statements from the American Academy of Pediatrics emphasizing that the introduction of complementary feedings before six months of age only substitutes foods that lack the protective components of human milk and that exclusive breastfeeding should be used as the reference or normative model for feeding infants. Six months is the age at which most healthy infants are developmentally ready to handle complementary foods. Infants do not need complementary foods for nutritional reasons at younger ages--either breastmilk or iron-fortified infant formula would entirely meet the nutritional needs of most infants. Providing complementary foods beginning at age six months is consistent with common guidelines for clinical practice in the field of pediatrics. 5. Disallowance of Low-Iron Infant Formula in Food Packages I, II and III It is well documented that iron-fortified infant formulas play an essential role in providing iron in the diets of non-breastfed infants. According to AAP, there are no known medical conditions warranting the use of a low-iron infant formula during infancy. In addition, the IOM recommends that the WIC Program continue to provide iron-fortified infant formula to prevent iron-deficiency anemia in infants. This proposed rule would revise WIC food package regulations to prohibit the issuance of all low-iron infant formulas to any infants. 6. Proposed Revisions and Maximum Monthly Allowances in Food Package I--Infants Less Than 6 Months of Age As recommended by the IOM, under this proposed rule, Food Package I would provide iron-fortified infant formula only. Infant formula would continue to be authorized in liquid concentrate, powder, and ready-to- feed (RTF) physical forms. However, powder [[Page 44792]] infant formula would be recommended in Food Package I for partially breastfed infants ages one month through three months due to its longer shelf life, less waste and capability to mix the small amounts needed for the partially breastfed infant. Powder and RTF physical forms are substitutes or alternatives to liquid concentrate and may be substituted at amounts that provide the approximate number of reconstituted fluid ounces as the liquid concentrate form of the same infant formula. Currently, in both Food Packages I and II, infant formula allowances are expressed in terms of fluid ounces of liquid concentrate, pounds of powder, and fluid ounces of RTF. WIC State agencies have suggested to FNS that maximum monthly formula allowances for liquid concentrate and powder physical forms be expressed in terms of reconstituted fluid ounces. The Infant Formula Act of 1980 and its amendments standardized the nutrient content of infant formulas ensuring that infant formulas distributed in the United States contain certain minimum levels of calories and nutrients per reconstituted fluid ounce. Therefore, the Department is proposing to express maximum monthly allowances of infant formula of liquid concentrate and powder physical forms in reconstituted fluid ounces according to the mixing directions on the container for preparation for consumption. RTF liquid will continue to be expressed in fluid ounces. a. Liquid Concentrate Infant Formula. All liquid concentrate infant formula currently marketed is packaged in 13 fluid-ounce cans, is designed to be mixed with an equal quantity of water (i.e., has a 1:1 dilution ratio) and provides the standard dilution of 20 kilocalories per fluid ounce reconstituted. Thus, 403 fluid ounces of liquid concentrate formula reconstitutes to 806 fluid ounces. The proposed maximum monthly formula allowances are evenly divisible by the 13- fluid-ounce cans of liquid concentrate infant formula. b. Powder Infant Formula. The reconstituted yields for powder formulas vary according to types and brands of products. Powder milk- based infant formulas designed for healthy, full-term infants have among the highest yields when compared to soy-based infant formulas and exempt infant formulas. This proposed rule would revise the substitution rate for powder infant formula since the current substitution rate of 8 pounds powder per 403 fluid ounces liquid concentrate is no longer appropriate and could result in providing excess amounts of formula in some cases. The IOM recommended rounding to whole cans in order to reach recommended amounts of infant formula. Therefore, the proposed maximum monthly allowances of liquid concentrate and RTF are evenly divisible by the whole can sizes of infant formula currently available. However, none of the whole container sizes of powder infant formula commonly issued by State agencies would provide the same number of reconstituted fluid ounces as the liquid concentrate form of the same product in whole containers. The Department recognizes that powder is the most economical form for State agencies to issue. Therefore, in order to provide a nutritional benefit amount recommended by the IOM and to provide administrative flexibility for the issuance of infant formula, this proposal would authorize an amount of powder infant formula that would provide at least the maximum monthly allowance as the reconstituted liquid concentrate form of the same infant formula in the same food package and infant feeding option (fully formula fed or partially breastfed). State agencies would be required to provide at least the number of fluid ounces as the same reconstituted liquid concentrate infant formula up to the maximum monthly allowance for reconstituted powder infant formula. This would ensure that participants receive comparable nutritional benefit no matter which physical form of infant formula they receive. The Department recognizes that participants issued powder infant formula may receive a slightly higher amount of reconstituted fluid ounces than the other forms due to the currently available container sizes and reconstitution rates. c. RTF Infant Formula. Proposed Sec. 246.10(e)(1)(iv) lists the reasons that RTF formula may be authorized as a substitute for liquid concentrate. The maximum monthly allowance of RTF formula provides about the same number of fluid ounces as the reconstituted liquid concentrate form of the same infant formula. The proposed maximum monthly allowances are evenly divisible by the 8 and 32-ounce whole containers of RTF infant formula. d. Maximum Monthly Allowances of Infant Formula. As recommended by the IOM, the maximum monthly allowance of infant formula would depend on the feeding option, physical form of infant formula provided (concentrated, powder, or ready-to-use), and the age of the infant, as summarized in Exhibit C of this preamble. Fully formula fed infants would receive the equivalent of about 806 fluid ounces reconstituted infant formula per month from birth through 3 months of age; thus, Food Package I is unchanged for fully formula fed infants from birth through 3 months of age. Fully formula fed infants 4 months through 5 months of age would receive the equivalent of about 884 fluid ounces of reconstituted infant formula per month; Juice and infant cereal would no longer be provided for infants ages 4 months through 5 months. Compared with the current package, the amount of infant formula is increased slightly for infants ages 4 months through 5 months to compensate in part for the decrease in nutrients and calories that results from the omission of juice and infant cereal; Partially breastfed infants ages 1 month through 3 months would receive the equivalent of about 364 fluid ounces reconstituted infant formula per month. Powder infant formula is recommended until the partially breastfed infants reaches four months of age due to its longer shelf life and to minimize waste; and Partially breastfed infants 4 months through 5 months of age would receive the equivalent of about 442 fluid ounces reconstituted infant formula per month. Since infant formula is supplemental to breast milk for partially breastfed infants, the maximum allowance of infant formula for partially breastfed infants is approximately 50 percent of the maximum allowance for fully formula fed infants. According to the IOM, this approach is designed to encourage mothers who are using the combination feeding method (feeding both breast milk and infant formula) to aim for a greater contribution of breast milk to the infant's intake. By definition, fully breastfed infants would not receive infant formula from the WIC Program. Instead, they would receive the benefit of breast milk, which provides the nutrients they need and a wide array of protective and health-promoting components in a safe form. [[Page 44793]] Exhibit C.--Maximum Monthly Allowances for Proposed 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 1 through 3 months 4 through 5 months 0 through 3 months 4 through 5 months -------------------------------------------------------------------------------------------------------------------------------------------------------- Infant Formula..................... NA.................... 364 fl oz 442 fl. oz. 806 fl. oz. 884 fl. oz. reconstituted liquid reconstituted liquid reconstituted liquid reconstituted 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 1 through 3 months of age. 7. Proposed Revisions and Maximum Monthly Allowances in Food Package II--Infants 6 Through 11 Months of Age As recommended by the IOM, this proposed rule would revise Food Package II to include the following changes: Food Package II would be provided to infants from 6 through 11 months of age. This package would differ substantially by infant feeding option, as shown in Exhibit D in this preamble. Infant formula would be decreased for fully formula fed infants to 624 fluid ounces of reconstituted liquid concentrate infant formula per month and for partially breastfed infants to 312 fluid ounces of reconstituted liquid concentrate infant formula per month; Infant foods would be added to the food package to encourage healthy dietary patterns; and Juice would be omitted to help make possible the addition of infant food fruits and vegetables. The amount of infant cereal in the package would be unchanged. The proposed decrease in the maximum allowance of infant formula is consistent with meeting nutritional requirements. The amount of infant formula proposed for partially breastfed infants reflects and encourages a greater contribution of breast milk to the infant's diet. Decreasing the maximum amount of infant formula and omitting juice makes possible needed enhancements. For example, the addition of infant food fruits and vegetables in the second six months of infancy introduces infants to a variety of nutritious foods at an age when almost all infants are developmentally ready for semisolid foods. The infant food meat for fully breastfed infants provides needed iron and zinc in forms with high bioavailability, and the larger quantities of infant food for fully breastfed infants may encourage some mothers to continue fully breastfeeding. Long-standing WIC policy has not authorized infant cereals that included fruit or infant formula ingredients. However, this restriction was never incorporated into regulatory language. This proposed rule would clarify in WIC regulations that infant cereals with the added ingredients of infant formula, milk, fruit, or other non-cereal ingredients are not authorized based on recommendations of the AAP and cost concerns. The AAP recommends that single ingredient foods be introduced one at a time in an effort to isolate food sensitivities and possibly avert the development of food intolerances. Although cereal/ fruit combinations may be appropriate once the risk of food sensitivity has diminished, these combination foods are more expensive than regular infant cereal. In reference to cereal/formula combinations, since infant formula is already provided in the food packages, it is not necessary to provide additional infant formula in combination with infant cereal. In addition, authorized infant cereals must continue to contain a minimum of 45 milligrams of iron per 100 grams of dry cereal. a. Authorized Infant Foods. Any variety of commercial infant food (fruit or vegetable) without added sugars, starches, or salt (i.e., sodium). Texture may range from strained through diced; and Any variety, single ingredient, of commercial infant food meat with broth or with gravy. Texture may range from pureed through diced. b. Maximum Monthly Allowance of Infant Foods (Fruits, Vegetables, and Meats) for Infant 6 through 11 months of age: For fully formula fed infants. 128 ounces of fruits and vegetables (e.g., 32 4-ounce jars); For partially breastfed infants. 128 ounces of fruits and vegetables (e.g., 32 4-ounce jars); For fully breastfed infants. 256 ounces of fruits and vegetables (e.g., 64 4-ounce jars); and For fully breastfed infants. 77.5 ounces of infant food meat (31 2.5-ounce jars. Fresh banana may replace up to 16 ounces of infant food fruit at a rate of 1 pound of bananas per 8 ounces of infant food fruit. Fresh bananas for infants in Food Package II would be issued via the standard food instrument system. As cited by the IOM Report, the rationale for providing a greater quantity of infant food fruits and vegetables in the package for fully breastfed infants is to provide added nutritional value to improve the parity with other infant packages, to provide sufficient fruits and vegetables to mix with infant food meats to increase the palatability of strained meats for older infants, and to encourage prolonged breastfeeding by adding to the convenience and monetary value of the food packages of the fully breastfeeding mother/infant pair. Exhibit D.--Maximum Monthly Allowances for Proposed Food Package II for Infants Ages 6 Months to 1 Year, by Feeding Option ---------------------------------------------------------------------------------------------------------------- Partially breastfed Fully formula fed Fully breastfed infants infants infants ---------------------------------------------------------------------------------------------------------------- WIC Formula Infant Formula................... ....................... 312 fluid ounces of 624 fluid ounces of reconstituted liquid reconstituted liquid concentrate formula. concentrate formula. WIC Food [[Page 44794]] Infant food (Fruits and 256 ounces of infant 128 ounces of infant 128 of ounces infant Vegetables). food fruits and food fruits and food fruits and vegetables. vegetables. vegetables. Infant food (Cereal)............. 24 ounces of iron- 24 ounces of iron- 24 ounces of iron- fortified infant fortified infant fortified infant cereal. cereal. cereal. Infant food (Meat)............... 77.5 ounces of infant food meat. ---------------------------------------------------------------------------------------------------------------- c. Rounding Up of Infant Foods. Infant Formula 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. This proposal reflects this authority by calculating and dispersing the infant formula over the timeframe of the food package category and infant feeding option (fully formula fed or partially breastfed). This proposal would identify the full nutritional benefit (FNB) provided by infant formula as the maximum monthly allowance of reconstituted fluid ounces of liquid concentrate for the food package category and infant feeding option. This proposal would require State agencies to issue at least the FNB but not more than the maximum monthly allowance for the food package category and infant feeding option. This proposal would require State agencies that use the rounding up option to issue infant formula in whole containers of the same size for administrative ease and to use the methodology described herein to calculate the number of cans of infant formula for issuance to participants. This proposal would require calculating and dispersing the infant formula over the timeframe of the food package category and infant feeding option (fully formula fed or partially breastfed). For example, a fully formula fed infant who participates in WIC from birth through eleven months of age would be issued infant formula in amounts provided by Food Package IA-FF from birth through 3 months of age, issued infant formula in amounts provided by Food Package IB-FF from four through five months of age, and issued infant formula in amounts provided by Food Package II-FF from 6 through eleven months of age. The timeframe or the total number of months that the participant will receive each food package is shown in Exhibit E. Exhibit E.--Food Package Timeframe ------------------------------------------------------------------------ Food package Maximum time frame ------------------------------------------------------------------------ I A-FF.................................... 4 months. I B-FF.................................... 2 months. II-FF..................................... 6 months. ------------------------------------------------------------------------ Exhibit F describes the methodology that State agencies must use to calculate the amount of infant formula dispersed over the timeframe of the food package category and infant feeding option, when using the rounding up option. Exhibit F.--Rounding Up Infant Formula Methodology ------------------------------------------------------------------------ ------------------------------------------------------------------------ 1.................... Multiply FNB by number of months in food package = Total amount of infant formula. 2.................... Determine yield (reconstituted fluid ounces) provided by the container issued by the State agency. 3.................... Divide total amount of infant formula by the container yield = total number of containers to issue. 4.................... Round up to the next whole same size container if the number of containers is not a whole number (e.g. 4.3 containers would round up to 5 containers). 5.................... Distribute the total containers across the food package timeframe as evenly as possible (e.g. 2,1,2,1). ------------------------------------------------------------------------ For example, a fully formula fed infant participant born January 1, 2006, would receive Food Package IA--FF issuance amount rounded over a 4-month timeframe multiplied by the FNB (806 fluid ounces reconstituted) to equal 3224 fluid ounces reconstituted total amount of infant formula for the 4-month timeframe. The total amount, 3224 fluid ounces reconstituted, would then be divided by the yield of fluid ounces reconstituted provided by the authorized container to determine the total number of containers needed to provide 3224 fluid ounces reconstituted. The reconstituted fluid ounce yield provided by container varies depending on container size and the reconstitution rate. Currently, Enfamil Lipil infant formula in a 12.9 ounce can reconstitutes to about 94 fluid ounces per container, Similac Advance infant formula in a 12.9 ounce can reconstitutes to about 96 fluid ounces per container, and Nestle Good Start Supreme infant formula in a 12.0 ounce can reconstitutes to about 87 fluid ounces per container. Therefore, the 3224 fluid ounces would be divided by either 94, 96 or 87 respectively, for a rounded up total of 35 12.9 ounce cans of Enfamil Lipil, or 34 12.9 ounce cans of Similac Advance, or 38 cans of 12 ounce cans Nestle Good Start Supreme. Using Enfamil Lipil as the example, the 35 cans would be dispersed over 4 months as evenly as possible, such as 9 cans the first month, 8 cans the second month, and 9 cans each for months 3 and 4. Exhibit G shows the number of powder infant formula containers that would be issued to an infant participant born January 1, 2006, for the fully formula fed infant food packages, using the rounding up methodology, for Enfamil Lipil, Similac Advance, or Nestle Good Start Supreme infant formulas for a 1-year certification timeframe. [[Page 44795]] Exhibit G.--Number of Powder Infant Formula Containers Issued to an Infant Participant Born 01/01/2006, for Food Packages I & II Fully Formula Fed (FF) Using Rounding Up ---------------------------------------------------------------------------------------------------------------- Nestle's Mead Johnson's Ross' Similac Good Start Enfamil Lipil Advance (number Supreme Approximate reconstitution amount per container (number of 12.9 of 12.9 oz. (number oz. containers) containers) 96 12.0 oz. 94 fl. oz. fl. oz. containers) 87 fl. oz. ----------------------------------------------------------------------------------------------------- ------------- Food Package I-FF A (FNB = 806 fl. oz. per month): January, age 0 months...................... 9.0 9.0 10.0 February, age 1 month...................... 8.0 9.0 10.0 March, age 2 months........................ 9.0 8.0 9.0 April, age 3 months........................ 9.0 8.0 9.0 ---------------------------------------------------------------- Food Package I-FF A subtotal........... 35 34 38 ================================================================ Food Package I-FF B (FNB = 884 fl. oz. per month): May, age 4 months.......................... 10.0 10.0 11.0 June, age 5 months......................... 9.0 9.0 10.0 ---------------------------------------------------------------- Food Package I-FF B subtotal........... 19 19 21 ================================================================ Food Package II-FF (FNB = 624 fl. oz. per month): July, age 6 months......................... 7.0 7.0 8.0 August, age 7 months....................... 6.0 6.0 7.0 September, age 8 months.................... 7.0 7.0 7.0 October, age 9 months...................... 6.0 6.0 8.0 November, age 10 months.................... 7.0 7.0 7.0 December, age 11 months.................... 7.0 6.0 7.0 ---------------------------------------------------------------- Food Package II-FF subtotal............ 40 39 44 ================================================================ Infant package total of formula issued. 94 92 103 ---------------------------------------------------------------------------------------------------------------- Infant Foods This proposed rule would allow State agencies to round up and disperse whole containers of infant foods (infant cereal, infant fruit and vegetables, and infant meat) over the timeframe of the food package category and infant feeding option (fully formula fed, fully breastfed or partially breastfed) to allow all participants to receive the maximum monthly allowance of infant foods as specified in regulations. This is consistent with the authority allowing State agencies to round up infant formula. Rounding up of infant foods provides administrative flexibility to State agencies since container sizes of infant foods vary and rounding ensures that infants would receive the full nutritional benefit recommended by the IOM. This proposal would require State agencies that use the rounding up option for infant foods to use the same methodology proposed to calculate and disperse infant formula over the timeframe of the food package category and infant feeding option. Exhibit H describes the methodology that State agencies must use to calculate and disperse infant foods over the timeframe of the food package category and infant feeding option. Exhibit H.--Rounding Up Infant Food Methodology ------------------------------------------------------------------------ ------------------------------------------------------------------------ 1.................... Multiply maximum monthly allowance by number of months in food package = Total amount of infant food in ounces. 2.................... Determine the container size (e.g., ounces) of infant food issued by the State agency. 3.................... Divide total amount of infant food by the container size = total number of containers to issue. 4.................... Round up to the next whole same size container if the number of containers is not a whole number (e.g. 54.3 containers would round up to 55 containers). 5.................... Distribute the total containers across the food package timeframe as evenly as possible (e.g.10, 9, 9, 9, 9, 9). ------------------------------------------------------------------------ For example, a fully formula fed infant participant born January 1, 2006, would receive Food Package II from July through December, for a 6-month total timeframe. The infant may receive 24 ounces infant cereal per month, multiplied by 6 months, to equal a total of 144 ounces infant cereal. Currently, authorized infant cereal is packaged in 8- and 16-ounce containers. Therefore, either 18 8-ounce containers or 9 16-ounce containers of infant cereal would be provided over the food package timeframe. The 18 8-ounce containers can be divided equally by the 6-month food package timeframe and results in 3 8-ounce containers of infant cereal issued each month. The 9 16-ounce containers must be dispersed across the food package timeframe as evenly as possible, for example, two containers per month issued for three months and one container per month issued for three months on alternating months (e.g. 2, 1, 2, 1, 2, 1) to equal the 9 total containers. The Department is seeking comments on the proposed methodology to round up and disperse infant formula and infant foods. d. Department Soliciting Input on changes to infant feeding packages. The proposed infant feeding options represent a dramatic change in infant food package issuance procedures. The procedural changes affect not only assignment to one of three feeding options but impact the delivery of other nutrition services as well. We are aware [[Page 44796]] that WIC State agencies will experience challenges in staff training, assessment of the mother-infant dyad, programming of management information systems, and the provision of participant nutrition education. Successful implementation of the infant feeding options may require enhanced nutrition education, peer counseling, and referral activities to support the successful establishment of breastfeeding. The Department is soliciting input on the potential impacts of the proposed changes to Food Package I and II, and any comments or suggestions on alternative options for FNS to consider. Specifically, FNS would like comments regarding the following: The three infant feeding options; Impact of proposed changes on breastfeeding rates; Staff training and building support for proposed changes among WIC staff; The expression of monthly maximum amounts of infant formula in reconstituted fluid ounces; The methodology used to round up infant formula and infant foods; Participant nutrition education; and Administrative feasibility. C. Overview of Revised Food Package IV for Children Currently there is one package for children without special dietary needs, Food Package IV for children ages 1 to 5 years (currently Sec. 246.10(c)(4)). This proposed rule would continue to provide Food Package IV to children ages 1 through 4 years. However, as recommended by the IOM, only whole milk would be authorized for children age one year (12 through 23 months), and only milk with a fat content not to exceed two percent would be authorized for children 2 years of age and older. Compared with the current package, the revised food package, as recommended by the IOM, would include smaller amounts of milk and juice but would add fruits, vegetables, and whole grains. Cheese would continue to be allowed as a partial substitute for milk; however, the maximum cheese substitution would be reduced from current WIC regulations. As recommended by the IOM, with proper medical documentation, soy-based beverage and tofu would be authorized as substitutes for milk. As cited by the IOM Report, these changes would make the entire food package for children more consistent with the DGA 2005 (12) and help ensure a more balanced nutrient intake for WIC participants. D. Overview of Revised Food Packages V, VI, and VII for Women Currently, there are three food packages for women without special dietary needs. These are Food Package V for pregnant and breastfeeding women; Food Package VI for nonbreastfeeding postpartum women; and Food Package VII for breastfeeding women who do not receive infant formula for their infants from the WIC Program (currently Sec. 246.10(c)(5) through (c)(7)). As recommended by the IOM, this proposed rule would retain these food packages, but as discussed in section V.B. of this preamble, would add for the purposes of assigning a food package, a definition of partially breastfeeding. Currently, a woman is certified to be eligible for the Program as a breastfeeding woman if she is breastfeeding on the average of at least once a day and meets other WIC eligibility criteria. Under this proposed rule, a woman would continue to be certified eligible as a breastfeeding woman if she is breastfeeding on the average of at least once a day. However, whether or not she receives a food package and which food package she is assigned would be based on the amount of infant formula she requests and receives from WIC for her infant and the age of the infant. Under this proposed rule, Food Package V would be provided for pregnant and partially breastfeeding woman (up to 1 year postpartum) whose infants participate in the WIC Program and receive infant formula in amounts that do not exceed the maximum allowances for the partially- breastfed infant food packages, as appropriate for the age of the infant. Food Package VI would continue to be provided for non-breastfeeding postpartum women (up to 6 months). Food Package VI would also be provided to partially breastfeeding postpartum women (up to 6 months) whose infants are receiving more than the maximum allowances for the partially breastfed infant food package, as appropriate for the age of the infant. In terms of the variety of foods and amounts offered, Food Package V for partially breastfeeding women is more desirable than Food Package VI. Food Package V provides whole wheat bread or other whole grains, peanut butter in addition to legumes, and more milk and juice than Food Package VI. Food Package VI does not provide whole wheat bread or other whole grains, and provides the option of peanut butter or legumes, but not both. The incentive value of Food Package V may encourage a higher level of breastfeeding among mothers who both breastfeed and formula-feed their infants. Food Package VII would continue to be provided to fully breastfeeding women whose infants do not receive infant formula from the WIC Program. In addition, based on estimates of increased nutrient and energy needs of women pregnant with more than one fetus, these women, as recommended by the IOM, would now receive Food Package VII rather than Food Package V. Women who are fully breastfeeding multiple infants would be prescribed 1.5 times the maximum amounts of Food Package VII to cover their higher needs for energy and nutrients. Women partially breastfeeding multiple infants would receive also Food Package VII. Further, all breastfeeding women would be prescribed Food Package VII during the first month postpartum because their infants would not be receiving any infant formula from the WIC Program. As recommended by the IOM, under this proposed rule Food Package VII, for fully breastfeeding women, would provide the greatest variety and quantity of food; and Food Package VI for postpartum women, would provide the least. Compared with the current food packages, all 3 revised food packages for women would provide smaller amounts of milk products, eggs, and juice; the same amount of iron-fortified cereal; add a requirement that cereals be whole grain; and would add fruits and vegetables. Whole grain bread or other whole grains would be added to Food Packages V and VII. The food packages for women would no longer authorize whole milk, and would allow several alternatives to cow's milk to address calcium needs. Canned light tuna would continue to be allowed in Food Package VII; canned salmon and sardines would be authorized as substitutes for light tuna. Women greater than 6 months postpartum whose infants do not meet the definition of a partially breastfed infant. The IOM recommends 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 has determined that this approach is incongruous with the definition of breastfeeding in WIC regulations at Sec. 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 [[Page 44797]] 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. As such, rather than adopt IOM's recommendation in its entirety, FNS proposes to revise the definition for WIC ``participation'' at Sec. 246.2. The definition would now include the number of 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 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. E. Inclusion of Fruits and Vegetables in Food Packages III through VII As recommended by the IOM, this proposed rule would add a variety of fruits and vegetables to Food Packages III, IV, V, VI, and VII (currently Sec. 246.10(c)(3) through (c)(7)). The IOM Report states that the addition of fruits and vegetables to WIC food packages is consistent with a major recommendation of the DGA 2005 (12)--namely, to increase daily intake of fruits and vegetables. The IOM's basis for recommending the addition of fruits and vegetables was the substantial body of literature that supports the association of fruit and vegetable consumption with reduced risk of chronic disease including stroke and perhaps other cardiovascular diseases, some cancers, and type 2 diabetes. Evidence also suggests that increased fruit and vegetable consumption may be useful in programs to promote and sustain loss of body weight in overweight individuals. The IOM and FNS received many public comments from health professionals, consumers, WIC Program staff, WIC participants, and others, advocating for the inclusion of fruits and vegetables in the WIC food packages. 1. Authorized Fruits and Vegetables As recommended by the IOM, this proposed rule would include fresh and processed (canned, frozen, and dried) fruits and vegetables. Fresh, canned, and frozen fruits and vegetables would be authorized for children and women in Food Packages III through VII. Dried fruits and dried vegetables would be authorized for women in Food Packages III and V through VII. As recommended by the IOM, dried fruit and dried vegetables would not be authorized for children in Food Packages III or IV to reduce the risk of choking. As recommended by the IOM, to improve the consumption of fresh fruits and vegetables and the appeal of this option, especially for people of different cultural backgrounds, this proposed rule would place minimal restrictions on participant choice of fresh produce. Because a fresh produce option might not be practical in some situations, a processed option and a combined fresh and processed option for fruits and vegetables are also proposed. As recommended by the IOM, for children and adults in Food Packages III-VII, different physical forms of fruit and vegetable offerings are proposed, as follows. a. Fresh fruits and vegetables. Any variety of fresh whole or cut fruit without added sugars; and Any variety of fresh whole or cut vegetable, except white potatoes, without added sugars, fats, or oils. b. Processed fruits and vegetables (canned, frozen, and dried). Any variety of canned fruits, including applesauce; juice pack or water pack without added sugars, fats, oils, or salt (i.e., sodium); Any variety of frozen fruits without added sugars; Any dried fruit or vegetable without added sugars, fats, oils, or salt (i.e., sodium); and Any variety of canned or frozen vegetables, except white potatoes (orange yams and sweet potatoes are allowed), without added sugars, fats, oils. 2. Restrictions on Authorized Fruits and Vegetables This proposed rule would not authorize: White potatoes (orange yams and sweet potatoes are allowed); Catsup or other condiments; Pickled vegetables and olives; or Soups. IOM's recommended restriction on white potatoes is based on the amounts suggested in DGA 2005 (12) 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. Although not addressed by IOM, the Department is proposing further restrictions on fruits and vegetables; and therefore this proposal would also not authorize: Herbs or spices; Edible blossoms and flowers, e.g., squash blossoms (broccoli, cauliflower and artichokes are allowed); Creamed or sauced vegetables; Vegetable-grain (pasta or rice) mixtures; Fruit-nut mixtures; Breaded vegetables; Fruits and vegetables for purchase on salad bars; Ornamental and decorative fruits and vegetables such as chili peppers on a string, garlic on a string; gourds, painted pumpkins; Fruit baskets and party vegetable trays; Fruit leathers and fruit roll-ups; Peanuts; Juices (juices are provided as a separate WIC food category); Canned and dried mature legumes (these legumes are provided as a separate WIC food category); and Items such as blueberry muffins and other baked goods. 3. 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. However, as discussed earlier in this preamble, to achieve cost neutrality, the Department has reduced this recommendation by $2 for both women and children. Therefore, this proposed rule establishes the value of fruit and vegetable vouchers at levels of $8 per month for women and $6 per month for children. The Department welcomes comments or suggestions from State agencies regarding cost-neutral options for providing vouchers at the IOM-recommended levels. a. Fresh produce option. Because few fresh fruits and vegetables are sold in uniform weight units with uniform bar codes, and their prices vary considerably across seasons, regions, and stores, they cannot be prescribed in quantity terms and still control the overall cost of the WIC food packages. Therefore, this proposal would include cash-value food instruments at the level of $8 per month for women and $6 per month for children for fresh fruits and vegetables. [[Page 44798]] Cash-value food instruments will be set at $6 for children and $8 for women in the year in which the proposed food package revisions take effect. FNS will adjust the maximum value of the vouchers in whole dollar increments to reflect the sum of annual, un-rounded increases in inflation using the Bureau of Labor Statistics' Consumer Price Index for Fresh Fruits and Vegetables. In the fiscal year in which the whole dollar increment accrues, the Department would have the option to increase the value of the fruit and vegetable vouchers by the whole dollar increment. If the Department elects this option, it would request the funding necessary for the additional program costs. The recommendation to use cash-value food instruments for fresh fruits and vegetables is based on input IOM received from vendors in public meetings. The IOM also cited two recent pilot studies in which cash-value vouchers for fresh fruits and vegetables were provided to WIC participants. (18, 19) The experience from both pilot studies, albeit unpublished at the present time, suggests that providing fresh produce to WIC participants using cash-value vouchers increased the intakes of fruits and vegetables, added variety to the diets of WIC participants, and was highly acceptable to WIC participants of various ethnic/cultural backgrounds. Because of greater participant choice, lower cost in many States, and potentially greater nutrient contribution from fresh produce, State agencies are encouraged to offer fresh produce to the extent possible. b. Processed fruit and vegetables option. As recommended by the IOM, this proposal would allow processed (canned, frozen, and dried) fruits and vegetables to be substituted when fresh produce is limited and to accommodate participant preference. The Department proposes to also provide the processed options via the $8 or $6 cash-value food instrument. State agencies would be authorized to allow the cash-value food instrument to be used to obtain any combination of fresh produce and processed fruits and vegetables, thereby providing maximum flexibility for the participant. In addition, the ability to combine all fruit and vegetable options on one type of cash-value food instrument should reduce the administrative complexity for State agencies and vendors. State agencies are encouraged to allow participants the wide variety of choices within the authorized fresh and processed options. To ensure participant choice among the fresh and processed fruit and vegetables authorized by the State agency, Sec. 246.12(g)(3)(i) would be revised to require that vendors authorized by the State agency carry a minimum of two varieties each of fruits and vegetables, in any combination of fresh and processed. However, it is the Department's expectation that more than two varieties each of fruits and vegetables be authorized by State agencies. The Department welcomes comments or suggestions on ways to provide the widest variety of choice without introducing undue program complexity or administrative burden. 4. Implementation of Fruit and Vegetable Options Under this proposed rule, State agencies would be encouraged to issue small denomination, such as $2, cash-value fruit/vegetable food instruments. In consideration of the perishable nature of fresh fruits and vegetables, small denominations are needed so the participant can obtain small amounts of fresh product at various times during the month, lessening the chance of food spoilage and waste. Any combination of authorized fresh or processed fruit or vegetable would be allowed in quantities with a value up to the amount of the cash-value food instrument(s). The Department welcomes comments or suggestions on implementation of fresh fruit and vegetable options. a. Operational requirements for cash-value fruits and vegetables food instruments. Under this proposed rule, cash-value food instruments for fruits and vegetables, as with any WIC food instrument, would be subject to the requirements in Sec. 246.12--Food Delivery Systems. Section 246.12 sets forth design and operational requirements for food delivery systems, including vendor authorization, accountability, redemption and disposition of food instruments. b. Benefit delivery. While most of the proposed food package changes could be administered via existing State benefit delivery systems, the cash-value food instruments for the purchase of fruits and vegetables differs from other WIC benefits which provide specified quantities of approved food items. The fruit and vegetable benefit would 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. States and vendors would have to modify operations and procedures to issue, transact, and process the redemption of a cash value benefit. The implementation of a cash value paper voucher or check may prove administratively burdensome and prohibitively expensive given additional processing costs that may be applied to each transaction, depending on a State's benefit processing arrangement. The cost and implications of these changes in the existing WIC benefit delivery system is an area that must be carefully considered. The fruit and vegetable benefit may lend itself to electronic benefit delivery in line with current trends in commercial retail transaction processing and consistent with the FNS 5-Year Plan for 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. These pilots are testing and evaluating the feasibility of smartcard and online technologies. By 2008, FNS hopes to identify national model(s) that are technically and financially viable for retail transaction processing for WIC EBT. 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. These solutions could provide participants with greater flexibility in redeeming benefits by allowing them to spread their purchases out across the month, although some solutions will likely prove prohibitively costly in relation to the cash value of the proposed benefit. FNS will explore the range of possibilities for using existing commercial infrastructure to administer the fruit and vegetable benefit including WIC EBT smartcard and online solutions as well as commercial debit cards and other technologies. FNS will assess the administrative burden, technical feasibility, advantages and costs of alternative approaches to delivering the cash value benefit for fruits and vegetables. We recognize that this benefit will pose challenges and added costs for the existing paper voucher and check system and that various technical approaches may also be costly and complicated to develop, implement, and operate. Since the implications of alternative solutions are likely to vary across State WIC agencies depending on their current participating vendor characteristics and benefit delivery systems, several different options may be needed to deliver the cash value benefit throughout the Program. FNS seeks to minimize the complexity and cost associated with administering this benefit and invites [[Page 44799]] comments and suggestions on alternative approaches and considerations. c. Farmers' markets. The Department proposes to allow the State agency to authorize farmers at farmers' markets to accept the WIC cash- value food instrument for fruits and vegetables. Such markets would have to meet vendor selection criteria specified at Sec. 246.12(g)(3) and would be subject to the vendor agreement requirements outlined in Sec. 246.12(h)(3). F. Addition of Peanut Butter in Food Package V As recommended by the IOM, this proposed rule would add 18 ounces of peanut butter in Food Package V (currently Sec. 246.10(c)(5)) to improve the intake of several nutrients, including iron, folate, Vitamin E, and fiber, in the diets of pregnant and breastfeeding women. At present, Food Package V allows peanut butter only as an alternative to dry beans and peas. G. Addition of Legumes in Food Package VI As recommended by the IOM, this proposed rule would add 1 pound of dried beans or peas or, as an alternative, 18 ounces of peanut butter, to Food Package VI for postpartum women (currently Sec. 246.10(c)(6)). Currently Food Package VI does not provide legumes of any kind. This addition would improve the intake of several nutrients, including iron, folate, Vitamin E, and fiber, in the diets of these participants. H. Addition of Canned Mature Legumes as an Optional Substitute for Dry Legumes in Food Packages III-VII As recommended by the IOM, this proposed rule would allow the substitution of canned mature beans/peas for dry mature beans/peas in Food Packages III, IV, V, VI and VII (currently Sec. 246.10(c)(3) through (c)(7)). This substitution, currently authorized for homeless persons, would be allowed under this proposed rule to increase flexibility and variety in food choices for participants receiving Food Packages III-VII. 1. Authorized Types of Canned Beans This proposed rule would allow any type of mature dry beans in canned form. Examples include but are not limited to black beans (``turtle beans''), blackeye peas (cowpeas of the blackeye variety, ``cow beans''), garbanzo beans (chickpeas), great northern beans, kidney beans, lima beans (``butter beans''), pinto beans, navy beans, soybeans, split peas, and lentils. Baked beans may be provided for participants with limited cooking facilities, at the State agency's discretion. 2. Restrictions on Authorized Types of Canned Beans This proposed rule would not authorize the following forms of canned beans: Soups; With the exception of baked beans, those containing added sugars, fats, meat or oils as purchased; Immature varieties of legumes, such as those used in canned green peas, green beans, snap beans, orange beans, and wax beans; or Baked beans with meat, e.g., beans and franks. 3. Maximum Monthly Substitution Rate As recommended the by the IOM, this proposed rule would allow the substitution of 64 ounces (e.g., four 16-ounce cans) of canned mature beans/peas for 1 pound of dry mature legumes in Food Packages III-VII. Although not addressed by IOM, the Department proposes to allow the following additional substitutions in Food Package V and VII: 1 pound dry and 64 ounces of canned beans/peas (and no peanut butter) Or 2 pounds dry or 128 ounces of canned beans/peas (and no peanut butter) Or 36 ounces of peanut butter (and no beans). I. Addition of Whole Wheat Bread or Other Whole Grains to Food Packages III, IV, V, VII As recommended by the IOM, this proposal would add whole wheat bread or other whole grains for children and pregnant and breastfeeding women in Food Packages III, IV, V and VII (currently Sec. 246.10(c)(3) through (c)(5), and (c)(7)). This addition responds to recommendations of the DGA 2005 \(12)\ 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. 1. Authorized Whole Grains This proposed rule would include any bread that conforms to the Food and Drug Administration (FDA) standard of identity for whole grain bread as defined by 21 CFR 136.180 or 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 (e.g., must contain a minimum of 51% whole grains). Proposed allowable substitutions for whole grain bread would include brown rice, bulgur, oatmeal, and whole-grain barley without added sugars, fats, oils, or salt (i.e., sodium). Under this proposed rule, soft corn or whole wheat tortillas without added fats or oils would be allowed at the State agency's option. Using the minimum requirements and specifications in proposed Sec. 246.10(e)(12), State agencies would determine which types and brands of whole grain products to allow on State food lists. 2. Maximum Monthly Allowance As recommended by the IOM, this proposed rule would allow 2 pounds of whole grain bread or other whole grain options for children in Food Packages III and IV; and 1 pound of whole grain bread or other whole grain options for women in Food Packages III, V and VII. J. Milk and Milk Alternatives As recommended by the IOM, this proposed rule would continue to provide milk in food packages for children and women (currently Sec. 246.10(c)(4) through (c)(7)) as an important and concentrated source of vitamin D and calcium. This proposed rule would also authorize State agencies to provide alternatives for milk for individuals with lactose maldigestion and for those who avoid milk for cultural, religious, or other reasons. To maintain the nutritional content and cost neutrality of the food packages, some alternatives for milk (i.e., calcium-set tofu and cheese) would be allowed in limited amounts. 1. Nomenclature This proposed rule uses terminology for fat-reduced milk products as required by FDA on labeling for milk and milk products (21 CFR 101.62), i.e., ``reduced fat'' has two percent milk fat, ``low fat'' has one percent milk fat, and ``nonfat'' is skim or fat-free. The term ``fat-reduced'' is used in this proposal to refer to all varieties with two percent or less milk fat. 2. Authorized Milks 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 is an authorized milk in Food Packages IV, V, VI, and VII (currently Sec. 246.10(c)(4) through (c)(7)). WIC regulations also [[Page 44800]] require that all authorized milks must be pasteurized and contain at least 400 International Units of vitamin D per quart (100 IU per cup) and 2000 International Units of vitamin A per quart (500 IU per cup). As recommended by the IOM, under this proposed rule, only whole milk (not less than 3.25% milk fat) is authorized for children less than 2 years of age in Food Package IV (currently Sec. 246.10(c)(4)). For children two years of age and older and women (adolescent and adult) in Food Packages IV, V, VI, and VII (currently Sec. 246.10(c)(4) through (c)(7)), this proposed rule would authorize only milk with no more than 2% milk fat. 3. Maximum Monthly Milk Allowances The current maximum monthly allowances provide about 3.2 cups of milk a day for children and postpartum women and about 3.7 cups a day for pregnant and all breastfeeding women. As recommended by the IOM, this proposed rule would decrease the maximum monthly allowances for milk in all food packages. 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 2005 \(12)\. According to the IOM, amounts of milk provided by the WIC food packages need not exceed amounts recommended by DGA 2005 \(12)\. Therefore, this proposed rule would reduce the maximum monthly milk allowances for children 1 through 5 years and postpartum women from 24 quarts to 16 quarts, which would provide 2.1 cups per day. This proposed rule would reduce the maximum monthly milk allowances for pregnant and partially breastfeeding women from 28 to 22 quarts of milk (2.9 cups per day); and would reduce the maximum monthly milk allowances for fully breastfeeding women from 28 quarts to 24 quarts of milk (3.2 cups per day). a. Substitution rates of evaporated milk. This proposed rule would change the substitution rate of evaporated milk for fluid milk in Food Packages IV, V, VI, and VII (currently Sec. 246.10(c)(4) through (c)(7)). The current substitution rate is 13 fluid ounces of evaporated milk (or 26 fl. oz. reconstituted evaporated milk) per quart (or 32 fl. oz.) of fluid milk. This proposal would increase the substitution rate to 16 fluid ounces of evaporated milk per 32 fluid ounces of fluid milk or a 1:2 fluid ounce substitution ratio. This is based on a dilution rate of equal parts evaporated milk and water (i.e., 12 oz. can evaporated milk + 12 oz. water = 24 oz. reconstituted milk) and would ensure that participants issued evaporated milk would receive the same maximum monthly allowance of milk (reconstituted) as those issued fluid milk . The substitution rate is the same for both evaporated whole and evaporated fat reduced milks. When a combination of different milk physical forms (e.g., fluid plus evaporated) is provided, State agencies would have to ensure that the full maximum monthly allowances for milk are issued in Food Packages IV through VII. b. Substitution rates of dry milks. This proposed rule would change how the substitution rates of dry milks for fluid milk issued in Food Packages IV, V, VI, and VII (Sec. 246.10(c)(4) through (c)(7)) are expressed. Currently the rates are stated as: 1 pound of nonfat or lowfat dry milk per 5 quarts of fluid whole milk; or 1 pound of dry whole milk per 3 quarts of fluid whole milk. The Department proposes to express the new substitution rates in terms of reconstituted fluid ounce yields of dry milk to make it easier for State agencies to calculate the amount of dry milk to substitute for fluid milk. Although the container sizes commonly available for dry milks vary in weight, the reconstituted yields are consistent with the substitution ratios of dry milk to fluid milk stated above. For example, a 25.6 oz. box of nonfat dry milk reconstitutes to 8 quarts of fluid milk. This yield is consistent with the 1 pound of nonfat dry milk per 5 quarts of fluid whole milk WIC substitution ratio. The proposed change will better accommodate the wide range of container sizes for dry milks now on the market and those that may be added in the future. When a combination of different milk physical forms (e.g., fluid plus nonfat dry) is provided, State agencies would have to ensure that the full maximum monthly milk allowances are issued in Food Packages IV-VII. 4. Authorized Substitutions for Milk (Cheese, Tofu, Soy-Based Beverage) As recommended by the IOM to provide more flexibility for WIC State agencies and more variety and choice for WIC participants, this proposed rule would allow cheese to be substituted for milk for children at the rate of 1 pound of cheese per 3 quarts of milk. No more than 1 pound of cheese may be substituted for milk. State agencies could authorize, with medical documentation, amounts of cheese that exceed this substitution maximum for children in Food Package IV, up to the maximum allowance for fluid milk, in cases of lactose intolerance or other qualifying conditions. For women, this proposed rule would allow cheese or calcium-set tofu to be substituted at the rate of 1 pound of cheese per 3 quarts of milk or 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in this manner in Food Packages V and VI; however, no more than 1 pound of cheese may be substituted for milk. A maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore, a maximum of two pounds of cheese may be substituted for milk in Food Package VII. State agencies could authorize, with medical documentation, amounts of cheese or calcium-set tofu that exceed these substitution maximums, up to the maximum allowance for fluid milk, in cases of lactose intolerance or other qualifying conditions. This proposed rule would authorize 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. Under this proposed rule, soy-based beverage and tofu are not 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. Requiring medical documentation ensures that a child's medical provider is aware that the child may be at nutritional risk when milk is replaced by other foods. State agencies could authorize, with medical documentation, soy-based beverages to be substituted for milk for children in Food Package IV on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted, with medical documentation, for milk for children in Food Package IV at the rate of 1 pound of tofu per 1 quart of milk up to the total maximum allowance of milk. a. Authorized cheese. This proposed rule would clarify that a cheese that is a blend of authorized WIC cheeses (any combination of domestically produced, made with 100% pasteurized milk, Monterey Jack, Colby, natural Cheddar, Swiss, Brick, Muenster, Provolone, part-skim or whole Mozzarella, pasteurized American processed) is a WIC-eligible food. This proposed rule would clarify that cheeses that are labeled low, free, reduced, less, or light in the nutrients sodium, fat, or cholesterol are WIC-eligible. b. Authorized tofu. To be authorized, the tofu must be calcium-set (prepared with only calcium salts, e.g., calcium [[Page 44801]] sulfate), and may not contain added fats, sugars, oils or sodium. Under this proposed rule, tofu is not allowed as a substitute for milk for children in Food Package IV without medical documentation. c. Authorized soy-based beverages. Section 102 of the Child Nutrition and WIC Reauthorization Act of 2004 (Public Law 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 believes that it is imperative for WIC and the school nutrition programs to use the same standards for defining allowable soy-based beverages as alternatives to fluid milk. In setting minimum nutritional standards for soy-based beverages, FNS considered the IOM recommendations and Food and Drug Administration (FDA) standards, and examined the nutrient levels found in various types of milk using the Nutrient Database for Dietary Studies. \(20)\ IOM recommended allowing as milk alternatives only soy- based beverages that are fortified to contain nutrients in amounts similar to cow's milk. The IOM also recommended minimum levels per cup of 300 mg calcium and 120 International Units (IU) vitamin D. FDA, at 21 CFR Part 131, specifies that if added, milk should provide not less than 2000 IU vitamin A per quart (500 IU per cup) and 400 IU vitamin D per quart (100 mg per cup.) Among the varieties of fluid milk, whole milk (3.25% milkfat) typically provides the lowest levels of several nutrients. Since soy beverage may be allowed as a substitute for milk over a variety of fat content levels, a single, broadly applicable standard is needed. Further, FNS believes that the statutory requirement of Public Law 108-265 for nutritional equivalency takes precedence over the IOM recommendations for WIC. Therefore, whole milk was used as a benchmark for all nutrients except vitamins A and D, which already have Federally-established standards for fortification of fluid milk. The chosen levels of vitamins A and D derive from the milk fortification levels required by the FDA. Based on the above, this rule proposes that authorized soy-based beverages provide, at a minimum, the following nutrients: ------------------------------------------------------------------------ Per cup ------------------------------------------------------------------------ Calcium................................... 276 milligrams (mg). Protein................................... 8 grams. Vitamin A................................. 500 International Units (IU). Vitamin D................................. 100 IU. Magnesium................................. 24 mg. Phosphorus................................ 222 mg. Potassium................................. 349 mg. Riboflavin................................ 0.44 mg. Vitamin B12............................... 1.1 mcg. ------------------------------------------------------------------------ K. Cereal (for Women and Children) 1. Nomenclature This proposed rule would adopt the term ``breakfast cereal'' as a substitute for the terms ``cereal (hot or cold)'' and ``adult cereal (hot or cold)'' currently used in Sec. 246.10(c). FDA regulations (21 CFR 170.3(n)(4)) define breakfast cereals as those including ready-to- eat and instant and regular hot cereals. This term is consistent with USDA's long-standing interpretation of WIC cereals (hot or cold) as meaning breakfast cereals that are either ready-to-eat or those cereals (e.g., oatmeal, grits, cream of wheat) that require the addition of a liquid (e.g., water or milk) and heating or