Under the proposed rule, additional technical requirements would have been added as follows:

A total of 2,107 comment letters (1,945 of these were form letters) opposed the proposed medical documentation, primarily the documentation for children to receive soybased beverage. Commenter's stated that the medical documentation requirement for soybased beverage for children would create barriers to services and undermine FNS' efforts to provide foods that meet the cultural needs of participants. A small number of comments received from WIC staff primarily at the local level expressed concern that requiring medical documentation for the additional supplemental foods allowed in proposed Food Package III and requiring [[Page 68969]]
a prescribed amount per day is burdensome to participants, the medical community and WIC agencies.

FNS understands the potential administrative impact of requiring medical documentation for the provision of supplemental foods in Food Package III. However, these medical documentation requirements were proposed to ensure that the participant's healthcare provider, licensed in the State to write prescriptions, has determined that the supplemental foods are not medically contraindicated by the participant's qualifying condition. Participants that receive Food Package III are medically fragile and should be under the care of a healthcare professional for the purpose of close medical supervision essential for the participant's overall dietary management. Participants that receive Food Package III have qualifying medical conditions that preclude or restrict their use of conventional foods. Requiring medical documentation to include the additional supplemental foods allowed in proposed Food Package III and requiring an amount prescribed per day will ensure that the participant's health care provider is aware that WIC is providing supplemental foods that the health care provider has determined are not medically contraindicated by the participant's qualifying medical condition. Requiring the health care provider to designate an amount of WIC formula and the WIC supplemental foods allowed in the participant's diet will help the Certified Professional Authority (CPA) in designing nutrition education and a food package prescription that is appropriate to the participant's medical needs.

FNS acknowledges that some additional administrative tasks will occur because of medical documentation requirements for dairy alternatives. However, requiring medical documentation for soybased beverage for children ensures that a child's health care provider is aware that the child may be at nutritional risk when milk is replaced by other foods. The DGA \(1)\ stress the importance of milk consumption in the development of bone mass for children. The IOM noted that while soy products may be an appropriate choice for children who cannot consume milk, soy should not be made available to satisfy participant preference in the absence of medical need. Therefore, the proposed provisions for medical documentation for certain milk alternatives for children and women and for any supplemental foods authorized in proposed Food Package III are retained in this interim rule at 7 CFR 246.10(d). Proposed provisions related to revised medical documentation requirements that are not addressed in this preamble did not receive significant or substantial public comments and are retained in this interim rule as proposed.

5. Organic Foods

A number of commenters asked FNS to allow organic products within the authorized categories of foods in the WIC food packages. FNS points out that some organic forms of WICeligible foods meet the nutritional requirements set forth in current WIC regulations and are therefore authorized; this interim rule continues to authorize organic forms of foods that meet minimum nutrition requirements described in Table 4 of 7 CFR 246.10(e)(12). However, WIC State agencies are responsible for determining the brands and types of foods to authorize on their State WIC food lists. Some State agencies may allow organic foods on their foods lists, but this will vary by State. The decision may be influenced by a number of factors such as cost, product distribution within a State, and WIC participant acceptance.

C. Supplemental Foods and Food Packages

Note: In the interest of clarity, specific food package issues are discussed according to food item rather than food package and then the food package categories are discussed. The order of some of the topics in this section is modified from the proposed rule for the purposes of discussion.

1. Fruits and Vegetables in Food Packages III Through VII

The addition of fruits and vegetables to the WIC food packages was the most welcomed provision of the proposed rule across all commenter categories. Of the total of 40,026 comment letters that addressed fruits and vegetables, 39,961 (22,935 of these form letters) were favorable. The majority of the few opposing comments were from participants who did not want to see any changes to the current WIC food packages.

a. Maximum Monthly Allowances

The IOM recommended that fruits and vegetables be provided at levels of $10 per month for women and $8 per month for children. To achieve cost neutrality, the proposed rule would have established the value of fruit and vegetable vouchers at levels of $8 per month for women and $6 per month for children. A total of 3,166 commenters (2,940 of these form letters) asked FNS to increase the cashvalue vouchers to the level recommended by the IOM so that participants could receive one additional serving of fruits and vegetables per day. Commenters cited (1) the important benefits of fruits and vegetables in decreasing high blood pressure, heart disease, obesity, and cancer; (2) the generally low consumption of fruits and vegetables among WIC participants; and (3) the role that WIC can play in helping participants meet the DGA\(1)\ for fruit and vegetable intake. Commenters urged FNS to seek additional funds to provide the cashvalue vouchers at the level recommended by IOM.

A total of 692 commenters (562 of these form letters) asked FNS to consider, at a minimum, increasing the cashvalue fruit and vegetable voucher to $10 for fully breastfeeding women to further enhance the attractiveness of this package and provide an additional incentive for women to breastfeed.

While FNS is in full agreement with the IOM and commenters regarding the benefits of fruits and vegetables for WIC participants, it is important that revisions to the WIC food packages be cost neutral to protect the program's ability to serve the greatest number of eligible women, infants, and children. For fruits and vegetables, the IOM's intent was to move WIC participants towards some amount of increased fruit and vegetable consumption and, at the same time, reinforce the role of the WIC food packages in nutrition education. The proposed $8 and $6 cashvalue fruit and vegetable voucher fulfilled this intent while ensuring cost neutrality. Therefore, the provision will be retained in this interim rule as proposed for children and women in Food Packages IIIVI in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11). However, FNS has considered the benefits of increasing the value of the vouchers for fully breastfeeding women and has determined that a $2 increase can be accomplished while maintaining cost neutrality. This provision is therefore revised in the interim rule in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11) to reflect a cashvalue voucher of $10 for fully breastfeeding women in Food Packages III and VII.

Thirty commenters (23 of which were form letters) preferred that a set amount of fruits and vegetables be authorized per month, e.g., 3 pounds for a child, in lieu of a cashvalue voucher, for administrative ease and to control costs. FNS disagrees with this approach. A voucher, rather than a more narrowly defined fruit and vegetable option, offers flexibility, ensures participant access, and minimizes costs of [[Page 68970]]
compliance by administrative agencies and WICapproved vendors. Allowing participants to choose a wide variety of fruits or vegetables is intended to increase consumption by accommodating individual and culturallybased preferences.
(1) State agency responsibility to make available to participants at least two fruits and two vegetables from the category of fruits and vegetables in each authorized food package. FNS proposed that State agencies be required to make available at least two fruits and two vegetables to participants in Food Packages IIIVII. A total of 487 commenters (of which 418 were form letters) opposed the provision, believing that it undermines the IOM's recommendation to allow participants a wide variety of choices within the authorized fruit and vegetable options by authorizing State agencies to limit the number and variety of fruits and vegetables.

FNS' intention with this proposed provision was to ensure participant choice among the fruit and vegetables authorized by the State agency by expanding current WIC regulations that require State agencies to make available at least one food from each group in each food package. As described in the preamble to the proposed rule, it was FNS' expectation that more than two varieties each of fruits and vegetables would be authorized by State agencies. Therefore, the proposed provision is clarified in the interim rule at 7 CFR 246.10(b)(2)(ii)(B) to ensure its original intent to require State agencies to allow participants to use their cash value vouchers to purchase any WICeligible fruits and vegetables from among those authorized in Table 4 of 7 CFR 246.10(e)(12). This allows participants a wide variety of choices within the authorized fruit and vegetable options without restriction, in keeping with IOM recommendations. Further, the proposed provision at 7 CFR 246.10(b)(1)(i) is revised in this interim rule to disallow further restrictions on eligible fruits and vegetables.
(2) Minimum vendor stocking requirement. Similarly, at 7 CFR 246.12(g)(3)(i), FNS proposed that WIC authorized vendors carry a minimum of two varieties of fruits and vegetables to ensure participant choice at the retail level, while acknowledging that certain smaller vendors may not be able to stock as wide a variety of fruits and vegetables as larger vendors. A total of 472 commenters (418 form letters) disagreed with this provision, stating that setting a minimum vendor stocking requirement of two fruits and vegetables undermines the IOM recommendation to allow participants a wide variety of choices. Of these commenters, 269 (221 form letters) stated that State agencies should be allowed to specify minimum stocking requirements.

FNS points out that the proposed provision authorizes State agencies to establish different minimums for different vendor peer groups, thus allowing State agencies the flexibility to work with vendors to provide the maximum number and variety of fruits and vegetables that are locally accessible, culturally appropriate and affordable. However, it is required that all authorized vendors must stock at least two varieties of fruits, two varieties of vegetables, and one whole grain cereal authorized by the State agency. Therefore, the provision at 7 CFR 246.12(g)(3)(i) is retained in the interim rule as proposed; however, a technical oversight in the proposed rule has been corrected by clarifying that authorized vendors must stock at least two different varieties of fruits and two different varieties of vegetables.

b. Inflation Adjustment

FNS proposed an option to increase the value of the cashvalue fruit and vegetable vouchers by a whole dollar increment. A total of 124 commenters (75 of which were form letters) asked that FNS commit to a yearly inflation adjustment. FNS agrees with commenter that it is important to maintain the value of the vouchers over time. Cashvalue vouchers will be set at $6 for children and $8 for pregnant and partially breastfeeding and $10 for fully breastfeeding women in the year in which the food package revisions take effect. This interim rule adds a provision at 7 CFR 246.16(j) to adjust the maximum value of the vouchers in whole dollar increments using the Bureau of Labor Statistics' Consumer Price Index for Fresh Fruits and Vegetables. c. Minimal Restrictions on Authorized Fresh Fruits and Vegetables

To improve the consumption of fresh fruits and vegetables and to appeal to participants of different cultural backgrounds, the proposed rule would have authorized a wide variety of choices within the authorized fruit and vegetable options. To ensure nutritional integrity and cost neutrality, some minimal restrictions were proposed, e.g., no herbs or spices, edible blossoms of flowers, fruit leathers and fruit rollups. The majority of commenters favored the provision to authorize a wide variety of fruits and vegetables; however, 9 commenters (1 of which was a form letter) stated the opinion that the fruit and vegetable selections should be limited to sources of priority nutrients.

As stated in the Regulatory Impact Analysis that was published in the Federal Register as an appendix to the proposed rule, FNS considered alternatives to the proposed provision, including authorizing a more restrictive dark green and orange vegetable provision. This alternative was rejected because FNS believes that WIC food packages that reflect the IOM recommendations as closely as possible within the constraints of cost neutrality best reflect current scientific consensus on how to meet the supplemental dietary needs of WIC participants. The IOM chose not to emphasize the dark green and orange vegetable groups that tend to offer the highest concentrations of certain priority nutrients and instead recommended a fruit and vegetable option with few restrictions. Nutrition education offered by local WIC agencies will remain the primary method of encouraging participants to incorporate these high nutrient fruits and vegetables into their diets; under this interim rule participants remain largely free to choose the fruits and vegetables that they find most appealing.

Thirteen commenters (2 of which were form letters) believe that FNS should simplify the proposed minimal restrictions to ease
interpretation and implementation for participants, vendors, and staff. A total of 128 commenters (125 of which were form letters) asked FNS to allow State agencies flexibility to promote produce selections that come in standard packages with Universal Product Codes to minimize burden. As stated above, the nutrition education provided to participants is intended not only to encourage participant choice in the selection of fruits and vegetables, but also to provide information on shopping tips to obtain the maximum value of the voucher.

FNS is aware that State agencies will need to provide training and technical assistance to participants and vendors in implementing the food package changes. State agencies generally update their food lists on a biennial basis which requires training for both participants and vendors. Recognizing the extensive changes that will be necessary as a result of this rule, FNS will assist State agencies on vendor training, participant education, and other implementation issues. FNS also encourages State agencies to work with their vendor associations as they develop their new State procedures, particularly in regard to the cashvalue fruit/vegetable voucher.
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d. Disallowance of White Potatoes

Under the proposed rule, white potatoes would have been excluded from authorization in the WIC food packages. A total of 324 commenters (of these 291 were form letters) opposed the restriction of white potatoes. Twentyfour commenters stated that white potatoes should be included in the WIC food packages because they are versatile, economical and contain key nutrients. Thirteen commenters (1 form letter) from WIC State and local agencies stated that the exclusion of white potatoes would be hard to administer.

The restriction of white potatoes, as recommended by the IOM, is based on the amounts suggested in the DGA\(1)\ for consumption of starchy vegetables; food intake data indicating that consumption of starchy vegetables meets or exceeds these suggested amounts; and food intake data showing that white potatoes are the most widely used vegetable. Therefore, this provision is retained in the interim rule as proposed in Table 4 of 7 CFR 246.10(e)(12).
e. Implementation of Fruit and Vegetable Options
(1) Small dollar denomination of fruit and vegetable food instruments. In the preamble to the proposed rule, FNS encouraged State agencies to issue small denomination, i.e., $2, cashvalue fruit and vegetable food instruments. The small denominations were encouraged so the participant could obtain small amounts of fresh produce at various times during the month, lessening the chance of food spoilage and waste. A total of 200 commenters (of which 133 were form letters) disagreed with FNS' recommendation to provide the fruit and vegetable value in small denominations. The majority of those in opposition were WIC State and local agencies who stated that they should be allowed to determine, in partnership with vendors, the most cost effective method to provide the fruit and vegetable food instrument. FNS clarifies that although State agencies are encouraged to provide the cashvalue food instrument in small denominations for the reasons cited above and in the proposed rule, State agencies will determine the dollar denomination that is most beneficial to participants and cost effective given the State agency's infrastructure and environment.
(2) Paying cash with the fruit/vegetable voucher. Nineteen commenters asked that participants be allowed to pay the difference when the purchase exceeds the value of the fruit/vegetable voucher. Under current rules at 7 CFR 246.12(c), State agencies must ensure that participants receive their authorized supplemental foods free of charge. Such a restriction is necessary with the ``traditional'' WIC food instrument which reflects a specific quantity of foods that a participant must receive. In contrast, the fruit/vegetable cashvalue voucher reflects a maximum dollar allotment for the participant. Because it may be difficult to accurately estimate the exact purchase price of the fruit and vegetable selections, particularly when fresh and canned or frozen items are combined in one purchase, FNS concurs with commenters that participants should be allowed to pay the difference when the purchase of allowable fruits and vegetables exceeds the value of the fruit/vegetable voucher. This option would promote increased consumption of fruits and vegetables because participants would be more likely to utilize the full cash value, rather than partially redeem the voucher for fear of exceeding its cash value. The rule prohibits giving cash or credit to the participant for any unused portion of the fruit/vegetable voucher.
(3) Benefit delivery. While most of the food package changes will be administered via existing State benefit delivery systems, the cash value fruit/vegetable voucher will require changes to WIC benefit delivery systems to accommodate a more openended benefit determined by a cash value rather than a fixed quantity of a specific food item. State agencies and vendors must modify operations and procedures to issue, transact, and process the redemption of a cash value benefit. As described in the proposed rule, options for benefit delivery include Electronic Benefit Transfer (EBT) and farmers' markets.
(4) Farmers' markets. A total of 936 commenters (of which 170 were form letters) agreed with the provision to allow the fruit/vegetable cashvalue voucher to be redeemed by farmers at farmers' markets. Eleven commenters disagreed with the provision. Many commenters suggested that FNS ``Do no harm to the WIC Farmers' Market Nutrition Program (FMNP),'' and that funding for the FMNP not be reduced or procedures established that would adversely affect its operation or effectiveness.

FNS would like to clarify that the regulatory requirements for the FMNP are unchanged by this interim rule. Many commenters incorrectly believed that the proposal would have allowed FMNP coupons to be redeemed at authorized WIC vendors. This is not true; the proposal would have allowed the WIC fruit/vegetable cashvalue voucher to be redeemed at farmers' markets.

Of the commenters supporting the provision to allow farmers at farmers' markets to accept the fruit/vegetable cashvalue voucher, clarification was requested on several issueswould State agencies be required to authorize farmers at farmers' markets if they do not currently administer the FMNP; can farmers at farmers' markets be treated as seasonal vendors and only be allowed to accept the fruit/ vegetable voucher; can the State agency enter into one contract with the farmer that includes requirements for both WIC and the FMNP; and, can farmers' markets be excluded from the WIC vendor monitoring and audit requirements?

In response to commenter questions, this interim rule will not require State agencies to authorize farmers to accept the WIC fruit/ vegetable voucher. If a State agency chooses to authorize farmers at farmers' markets, it may modify its standard vendor agreement to address the unique circumstances of farmers' markets, as allowed by 7 CFR 246.12(h)(2). For example, the farmer's market agreement may only allow the farmer to accept the fruit/vegetable cashvalue voucher. In addition, the State agency can choose to enter into one agreement with the farmer that includes the requirements for both the WIC and WIC Farmers' Market Nutrition Programs. Further, farmers would be excluded from the vendor cost containment requirements. The farmers may also be excluded from the WIC monitoring requirements provided that they are included in the sample of farmers upon which the FMNP monitoring requirement is drawn. A new 7 CFR 246.12(v) has been added that specifies the requirements regarding the authorization of farmers at farmers' markets. The rule also adds definitions for cashvalue voucher and farmer (the same as that used in the FMNP), and modifies the food instrument requirements to identify the provisions that do not apply to the cashvalue voucher. As a result of the addition of the definitions of farmer and cashvalue voucher, we have made conforming amendments to the definitions of ``compliance buy,'' ``employee fraud and abuse,'' ``participants,'' ``participant violations,'' ``proxy,'' and ``nutrition services and administration'' to include these new terms as appropriate.
(5) Electronic Benefit Transfer (EBT). While the majority of State WIC agencies deliver benefits via paper checks or vouchers, 5 States are testing the feasibility of EBT and an additional State has adopted EBT statewide.
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Although it will take a number of years to implement WIC EBT fully in all States, the fruit and vegetable benefit may provide opportunities for alternative forms of benefit delivery and allow some States to move toward limited electronic benefit processing prior to the
implementation of EBT for all WIC purchases. In an effort to explore the range of possibilities for using existing commercial infrastructure to administer the fruit and vegetable benefit including WIC EBT smartcard and online solutions, commercial debit cards, and other technologies, FNS commissioned a study by the State Information Technology Consortium (SITC). Although the report is not yet final, preliminary findings indicate that for redemption of the fruit/ vegetable benefit, paper fruit and vegetable cashvalue checks or vouchers appear to be the least costly and easiest to implement by State agencies and food vendors within a 12month time period. The accountability for purchasing authorized fruits and vegetables remains the same as other food instrumentssubject to training store clerks regarding eligible food items and State compliance monitoring.

Debit type cards (EBT or credit/debit) with a magnetic strip offer potentially costeffective solutions that leverage the widely available card payment infrastructure in the United States. Magnetic strip cards in volume can be purchased for less than 25 cents each. There are, for instance, many large and smaller food vendors that already accept credit card payments or accept EBT cards using a four digit Personal Identification Number (PIN). These vendors include most authorized WIC vendors. Focus groups with participants were favorable to this type of alternative because of lessened stigma while shopping and the ability to purchase foods incrementally rather than forfeiting some items with a paper instrument. Technical standards would need to be modified to enable card use only within authorized WIC vendor locations and there may be a need to define standards to facilitate retailer and/or EBT contractor changes to existing store equipment and software. The accountability for purchasing eligible foods only is similar to paper food instruments.

WIC EBT solutions, online using magneticstrip cards or offline using smart cards, offer the greatest potential to ensure that only eligible fruits and vegetables are purchased with WIC cashvalue vouchers, but it would be more costly for all stakeholders. These solutions would match each item scanned to a State list of authorized UPC's and/or Price LookUp codes or PLUs. These solutions require additional investment by State agencies in cards, equipment, and maintenance of a much larger number of product Universal Product Codes and Price LookUp (PLUs) codes for fresh produce. The fresh produce industry has taken steps to institute greater standardization of PLUs; however, the seasonal and local produce suppliers do not always have means to use PLUs effectively. The draft SITC report suggests that pilot design and development will be necessary to identify cost effective solutions that can be widely adopted by State agencies and authorized vendors.

2. Peanut Butter and Legumes

The proposed rule would have added 18 ounces of peanut butter in Food Package V to improve the intake of several nutrients in the diets of pregnant and breastfeeding women. The proposed rule would also add legumes (dried beans/peas or peanut butter) in Food Package VI for postpartum women. Canned beans were proposed as an optional substitute for dry beans in Food Packages IIIVII. Of the 3,091 comment letters that addressed these provisions, 3,085 commenters (21 form letters)a large majority of whom were participantswere in favor of the proposed changes.

Six commenters asked that FNS eliminate peanut butter in the food packages for children because of concerns about peanut allergies. The IOM advised that children should avoid eating peanut butter from a spoon for safety reasons until age 3, but recommended that peanut butter continue to be offered in the WIC food packages for young children from 1 to 5 years of age. IOM has advised FNS that assessing for allergies and tailoring a young child's food package based on such assessment, as is current practice in WIC, is appropriate.

Therefore, the proposed peanut butter and legume provisions are retained in this interim rule as proposed.
3. Milk and Milk Alternatives

a. Maximum Monthly Milk Allowances

The proposed rule would have decreased the maximum monthly allowances for milk in all food packagesfor children and postpartum women, from 24 quarts to 16 quarts; for pregnant and partially breastfeeding women, from 28 to 22 quarts; and for fully breastfeeding women, from 28 quarts to 24 quarts of milk. Reducing the amount of milk provided through WIC is consistent with recommended limits on saturated fat, total fat, and cholesterol consumption put forth in the DGA,\(1)\ better aligns the amount of milk provided by WIC with the amounts recommended by the DGA\(1)\ and is consistent with the supplemental nature of the WIC Program.

The majority of nonparticipant commenters were in favor of the proposed reductions in milk. A total of 2,088 nonparticipant commenters (1,874 of which were form letters) were supportive of the reductions, while 66 commenters were opposed. Commenters opposing the reductions cited the contribution of milk to intakes of priority nutrients for WIC participants, e.g., calcium, Vitamin A, and potassium. Seventeen commenters stated that the food package for postpartum women should be increased to the levels provided to pregnant and partially breastfeeding women. Six commenters urged FNS to maintain milk at current levels and increase funding for other proposed food package provisions.

Comment letters from program participants reflected disappointment with the reductions in milk. A total of 1,831 comment letters were received from program participants who opposed the reductions; 225 participants wrote in favor of the proposed reductions.

FNS believes that the IOM set forth a series of sciencebased recommendations that, taken together, balance the various supplemental nutritional needs of participants. According to the IOM, amounts of milk provided by the WIC food packages need not exceed amounts recommended by the DGA.\(1)\ The proposed dairy levels for children (2 cups/day) and pregnant and breastfeeding women (3 cups/day) provide at least 100 percent of the servings recommended by the DGA.\(1)\ The level for nonbreastfeeding postpartum women is at least \2/3\ of the amount set forth by the DGA.\(1)\ The proposed maximum monthly allowance of milk allows a more balanced food package to provide the various high priority nutrients within cost constraints. Therefore, the proposed maximum allowances for milk are retained in this interim rule in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11). b. LowFat Milk

Under the proposed rule, only whole milk (not less than 3.25% milk fat) would have been authorized for children less than 2 years of age. For children two years of age and older and women, the proposed rule would have authorized only milk with no more than 2% milk fat to be consistent with current recommendations of the DGA
[[Page 68973]]
2005 to limit saturated fat and dietary cholesterol intake. A total of 3,058 commenters (2,663 of which were form letters) agreed with the provisions as written; 222 (10 of which were form letters) were opposed. One hundred seventy of those opposed were program participants. A total of 1,379 commenters (1,338 of which were form letters) stated that the fat content of milk for children and women should be reduced even furtherto no more than 1% of milk fat.

Seventyeight commenters (23 of which were form letters) asked FNS to allow the CPA the authority to prescribe the type of milk (whole milk or low fat milk) to participants, regardless of age or category, if medically necessary for such reasons as failure to thrive, underweight or overweight. FNS' position is that participants who have medical conditions that lead to a diagnosis of failure to thrive will likely be issued Food Package III. Therefore, to address commenters' concerns, this interim rule will authorize whole milk for children 1 through 4 years of age and women in Food Package III, with medical documentation. As proposed, only milk with no more than 2% milk fat is authorized for children 2 years of age and older and women in Food Packages IVVII. For these participants, nutrition education directed towards appropriate foods and food amounts should be provided for underweight or overweight participants. Nutrition education and individual tailoring of the food package within authorized parameters remain the most effective tools for WIC staff to use to help participants make appropriate choices based on their specific needs. c. Lactose Free Milk

Under the proposed rule, as long as a milk conforms to the FDA standard of identity for milk as defined by 21 CFR Part 131 and meets WIC Federal requirements, it would be an authorized milk in Food Packages IV, V, VI, and VII. Although not specified in the proposed rule, authorized milks that conform to the FDA standard of identity include, but are not limited to, calciumfortified, lactosereduced and lactosefree, acidified, and ultrahigh temperature (UHT) milks. FNS clarifies that these products are authorized, and that lactosefree or lactosereduced dairy products should be offered before nondairy milk alternatives to those participants with lactose intolerance who cannot drink milk. FNS also clarifies that medical documentation is not required for participants to receive lactosereduced and lactosefree milk.
d. Authorized Substitutions for Milk (Cheese, Tofu, SoyBased Beverage) (1) Cheese. The proposed rule would have reduced the amount of cheese that may be substituted for milk to one pound per month for children and pregnant, postpartum and partially breastfeeding women, and two pounds for fully breastfeeding women. Reducing the amount of cheese that may be substituted for milk will reduce saturated fat and total fat intake by children age two and older and women consistent with the DGA\(1)\ recommendations. Amounts of cheese that exceed the maximum substitution amounts may be authorized with medical documentation in cases of lactose intolerance or other qualifying conditions.

The majority of nonparticipant commenters were in favor of the proposed reduced cheese substitution amounts. A total of 754 non participant commenters (of which 589 were form letters) were supportive of the reduced substitution amounts, while 53 commenters were opposed. A total of 917 comment letters were received from program participants who opposed the proposed cheese allowances; 119 participants wrote to express support for the proposed amounts. Commenters opposing the cheese substitution amounts stated that cheese is culturally acceptable to most populations, and provides nutrients in a convenient and familiar way. Fourteen commenters asked FNS to maintain cheese at its current substitution levels and emphasize or require reducedfat cheese.

Reducing the maximum amount of cheese lowers the amount of saturated fat, total fat, and cholesterol in the WIC food packages. Within the context of the proposed revisions to the WIC food packages as a whole, the reductions in the current levels of cheese ensure that FNS is able to provide a more balanced nutrient intake for WIC participants while maintaining cost neutrality. Therefore, the proposed substitution levels for cheese are retained in this interim rule. (2) Soybased beverage and tofu. To provide more flexibility for WIC State agencies and more variety and choice for WIC participants, the proposed rule would have authorized soybased beverage to be substituted for milk for women in Food Packages V, VI and VII at the rate of 1 quart of soybased beverage for 1 quart of milk up to the total maximum allowance of milk. The proposal also would have allowed calciumset tofu to be substituted at the rate of 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk could be substituted in this manner in Food Packages V and VI, and a maximum of 6 quarts of milk may be substituted in Food Package VII. Under the proposed rule, soybased beverage and tofu would not be allowed as substitutes for milk for children in Food Package IV without medical documentation. The qualifying conditions may include, but are not limited to, milk allergy, severe lactose maldigestion, and vegan diets. Amounts of tofu that exceed the maximum substitution amounts may be authorized for women, with medical documentation, in cases of lactose intolerance or other qualifying conditions.

A total of 8,932 commenters (4,615 form letters) were supportive of adding soybased beverage and tofu to the WIC food packages as milk substitutes; 368 commenters (148 form letters) were not supportive. Comments received on medical documentation requirements for soybased beverage for children and FNS' rationale for retaining the provision in this interim rule as initially proposed are discussed in section IV.B.4. of this preamble.

As stated in the preamble to the proposed rule, Section 102 of the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108265) requires that nondairy beverages offered as an alternative to fluid milk in the National School Lunch Program and School Breakfast Program must be nutritionally equivalent to fluid milk and meet nutritional standards set by the Secretary of Agriculture. FNS, therefore, proposed that authorized soybased beverage provide, at a minimum, the following nutrients:
Calcium............................. 276 milligrams (mg) per cup. Protein............................. 8 grams per cup.
Vitamin A........................... 500 International Units (IU) per cup.
Vitamin D........................... 100 IU per cup.
Magnesium........................... 24 mg per cup.
Phosphorus.......................... 222 mg per cup.
Potassium........................... 349 mg per cup.
Riboflavin.......................... 0.44 mg per cup.

Vitamin B12......................... 1.1 mcg per cup.

A total of 340 commenters (255 form letters) were opposed to the proposed minimum nutrient standard, stating that fortification at these levels is not necessary, and that soybased beverage meeting the proposed minimum nutrition standard are not available in the marketplace. FNS believes that it is imperative for WIC and the school nutrition programs to use the same standards for defining allowable soybased beverage as alternatives to fluid milk. Therefore, the proposed minimum nutrient standard for soybased beverage
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is retained in this interim rule. FNS is aware of at least one soy based beverage in the marketplace that meets these requirements and anticipates that the marketplace will respond with additional products. To the extent that the marketplace doesn't respond with additional products, other options, such as tofu, are available for participants. (3) Yogurt. The IOM recommended adding yogurt to the WIC food packages as a milk substitute for children and women. However, in order to maintain cost neutrality, the proposed rule did not include yogurt. Of the 758 commenters that addressed yogurt, 749 (617 form letters) disagreed with FNS' decision not to include yogurt. Commenters stated that yogurt provides priority nutrients, and is convenient, popular, and culturally acceptable to WIC participants.

FNS agrees that yogurt would be a desirable dairy alternative to milk for WIC participants; however, the cost is simply prohibitive ($413.9 million over 5 years). In addition, FNS has determined that WIC participants will be able to get the calcium provided by yogurt through other foods authorized in these revised food packages. Lactosefree and lactosereduced dairy products, for example, are readily available in both urban and rural areas for those WIC participants with lactose intolerance. Calciumset tofu and soybased beverages are available to accommodate cultural preferences. Also, as noted earlier, a new 7 CFR 246.10(i) has been added to this interim rule to allow State agencies the flexibility to meet unanticipated cultural needs of participants.

It is important that revisions to the WIC food packages be cost neutral to protect the program's ability to serve the greatest number of eligible women, infants, and children. Therefore, FNS is unable to authorize yogurt in the WIC food packages in this interim final rule.

However, FNS solicits comments from State agencies as they implement the provisions of this interim rule about the extent to which WIC participants would benefit from the addition of yogurt, and whether that addition would be achieved in a costeffective way. In particular, we are interested in the impact of adding yogurt for women in Food Packages VVII.

FNS also solicits comments as to the feasibility of rebate agreements between yogurt manufacturers and individual States, so that yogurt could be provided to specific participant groups in the WIC program while maintaining costneutrality. State agencies are currently encouraged to explore the feasibility of cost containment systems, especially rebates, and to implement such a system where feasible for other WIC foods. In an effort to use their food grants more efficiently, 13 State agencies, which include 3 multiState contracts, have rebate contracts for juice (frozen and shelf), infant juice and/or infant cereal. If FNS were to consider including yogurt as a WIC eligible food through future rulemaking, FNS would be interested in the following types of information:

Finally, and as noted earlier, Section 203(c) of Public Law 108265 amended Section 17(c)(2) of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by requiring the Secretary to conduct, as often as necessary, a scientific review of supplemental foods available under the program and to amend the foods, as needed, to reflect nutrition science, public health concerns, and cultural eating patterns. As such, future reviews of the WIC food packages by FNS will be used to determine the need for yogurt.

4. Eggs

Under the proposed rule, the maximum monthly allowance for fresh shell eggs would have been reduced from the current 2 or 2\1/2\ to 1 dozen fresh shell eggs for children and women in Food Packages IV, V, and VI. For fully breastfeeding women in Food Package VII, the maximum monthly allowance was proposed at 2 dozen eggs.

A total of 1,469 commenters (266 of which were form letters) addressed the proposed egg reduction provision. Of the 492 non participant commenters, 406 were in favor of the proposed reductions. Those opposing stated that eggs provide important nutrients at relatively low cost. Of the 1,009 program participants who commented, 923 were opposed to the reduction in eggs.

The proposed maximum monthly allowance of eggs is consistent with recommendations of the IOM \(3)\ and the DGA \(1)\ to reduce cholesterol. In addition, the IOM determined that protein is no longer a priority nutrient for the WIC population. Within the context of the proposed revisions to the WIC food packages as a whole, the reductions in the current levels of eggs ensures that FNS is able to provide a more balanced nutrient intake for WIC participants while maintaining cost neutrality. Therefore, the proposed maximum monthly allowances for eggs are retained in this interim rule.

5. Juice for Children and Adults

The proposed rule would have reduced the maximum allowances of juice for women and children in Food Packages IVVII. According to the IOM, deleting or reducing the quantity of juice in the WIC food packages helps allow for the inclusion of whole fruits and vegetables while containing food costs, and is consistent with recommendations of the DGA\(1)\ and the American Academy of Pediatrics (AAP).

For children, the proposed maximum monthly allowance of juice would have been reduced from 288 fluid ounces to 128 fluid ounces. For pregnant and partially breastfeeding women, the proposed maximum monthly allowance of juice was reduced from 288 fluid ounces to 144 fluid ounces; for postpartum women from 192 fluid ounces to 96 fluid ounces; and for fully breastfeeding women, from 336 fluid ounces to 144 fluid ounces.

A total of 2,256 commenters (846 form letters) addressed the proposed reductions in juice. Of these, 1,610 commenters (846 form letters) were supportive of the juice reductions. Eighty two of those commenters recommended that juice be eliminated entirely from the WIC food packages and replaced with fruits and vegetables. Of the 646 commenters that opposed the reduction in juice, 633 were program participants. Nonparticipant commenters who opposed the reductions cited the nutritional benefits of juice and stated that the proposed reductions were too drastic.

Reducing the quantity of juice in the WIC food packages helps allow for the inclusion of whole fruits and vegetables while containing food costs. The reduction in the amount of juice provided for children to about 4 ounces per day is consistent with the AAP recommendation for that age group. The AAP also notes that juice does not provide any additional nutritional benefit beyond that of whole fruit. The reduced amount of juice for women is consistent with the recommendation of the DGA\(1)\ that whole fruits be used for a majority of the total daily amount of fruit.

Additionally, 34 commenters (14 form letters) expressed concern that juice package sizes need to be considered to ensure the full nutritional benefit of juice is received by participants. Over the years, there have been many changes in package sizes for all WIC eligible food categories, and FNS has struggled with how to manage these changes
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within WIC Program regulations that allow for a monthly maximum allowance of food that cannot be exceeded (except for the rounding option for infant formula and infant foods). It is not practical for FNS to be able to respond to all the variations in package sizing. Basing the maximum monthly allowance on package sizes would not guarantee that those package sizes will not change over time.

Therefore, FNS is retaining the proposed maximum juice allowances for children and women in this interim rule.

6. Whole Grains and Breakfast Cereals

To support the DGA\(1)\ recommendations to consume at least 3 servings per day of whole grains to reduce the risk of coronary heart disease and type 2 diabetes, to help with body weight maintenance, and to increase intake of dietary fiber, the proposed rule would have established a whole grain requirement for breakfast cereal in Food Packages IIIVII and added whole wheat bread or other whole grain options for children and pregnant and breastfeeding women in Food Packages III, IV, V and VII.

The addition of whole grains to the WIC food packages was popular across all commenter categories. A total of 17,165 comment letters (7,983 form letters) agreed with the whole grain provisions and 113 comment letters (5 form letters) disagreed with the provisions. While strongly supporting FNS' emphasis on whole grains, 876 commenters (764 form letters) expressed concern that the proposed nutritional requirement for whole grain breakfast cerealusing labeling requirements for making a health claim as a ``whole grain food with moderate fat content'' as defined by the Food and Drug Administration (FDA) in its December 9, 2003, Health Claim Notification for Whole Grain Foods with Modera

FOR FURTHER INFORMATION CONTACT Debra Whitford, Chief, Policy and Program Development Branch, Supplemental Food Programs Division, Supplemental Food Programs Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 528, Alexandria, Virginia 22302, (703) 3052746, or Debbie.Whitford@fns.usda.gov.