96-6178. Special Supplemental Nutrition Program for Women, Infants and Children (WIC): WIC Cereal Sugar Limit  

  • [Federal Register Volume 61, Number 53 (Monday, March 18, 1996)]
    [Proposed Rules]
    [Pages 10903-10907]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-6178]
    
    
    
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    DEPARTMENT OF AGRICULTURE
    Food and Consumer Service
    
    7 CFR Part 246
    
    
    Special Supplemental Nutrition Program for Women, Infants and 
    Children (WIC): WIC Cereal Sugar Limit
    
    AGENCY: Food and Consumer Service, USDA.
    
    ACTION: Notice of intent to propose rulemaking and solicitation of 
    comments.
    
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    SUMMARY: The Department is considering revising the Federal regulations 
    that limit the amount of sugar in WIC-eligible adult cereals. 
    Currently, Federal regulations specify that all adult cereals (hot or 
    cold) eligible for use in WIC food packages for women and children must 
    contain no more than 21.2 grams of sucrose and other sugars per 100 
    grams of dry cereal (i.e., 6 grams of sugar per dry ounce of cereal). 
    The majority of recent studies fail to document an association between 
    sugar consumption and an increased risk of developing chronic diseases. 
    The Department is therefore reviewing whether a revision in the Federal 
    limit on the sugar content for WIC-eligible adult cereals is warranted. 
    Consequently, the Department is soliciting public comments on the pros 
    and cons of revising the current requirement, and is inviting 
    suggestions on how the sugar limit should be changed, if a change is 
    deemed appropriate.
    
    DATES: To be assured of consideration, comments must be received on or 
    before June 17, 1996.
    
    ADDRESSES: Comments should be sent to Stanley C. Garnett, Director, 
    Supplemental Food Programs Division, Food and Consumer Service, USDA, 
    3101 Park Center Drive, Room 540,
    
    [[Page 10904]]
    Alexandria, Virginia 22302, (703) 305-2746. Comments on this Notice 
    should be labeled ``WIC Cereal Sugar Limit Notice.'' All written 
    comments will be available for public inspection during regular 
    business hours (8:30 a.m. to 5:00 p.m., Monday through Friday) at the 
    above-noted address.
    
    FOR FURTHER INFORMATION CONTACT: Barbara Hallman, Branch Chief, Policy 
    and Program Development Branch, Supplemental Food Programs Division, 
    Food and Consumer Service, USDA, 3101 Park Center Drive, Room 542, 
    Alexandria, Virginia 22302, (703) 305-2730.
    
    SUPPLEMENTARY INFORMATION:
    
    Executive Order 12866
    
        This Notice has been determined to be not significant for purposes 
    of Executive Order 12866 and therefore has not been reviewed by the 
    Office of Management and Budget.
    
    Regulatory Flexibility Act
    
        This action is not a rule as defined by the Regulatory Flexibility 
    Act (5 USC 601-612) and thus is exempt from the provisions of this Act.
    
    Paperwork Reduction Act
    
        This Notice does not contain reporting or recordkeeping 
    requirements subject to approval by the Office of Management and Budget 
    in accordance with the Paperwork Reduction Act of 1980 (44 USC 3507).
    
    Executive Order 12372
    
        This program is listed in the Catalog of Federal Domestic 
    Assistance Programs under No. 10.557 and is subject to the provisions 
    of Executive Order 12372, which requires intergovernmental consultation 
    with State and local officials [7 CFR Part 3015, Subpart V, and final 
    rule-related Notice published June 24, 1983 (48 FR 29114)].
    
    References
    
        Browne, Mona Boyd: ``Label Facts for Healthful Eating: 
    Educator's Resource Guide,'' 2nd ed., The Mazer Corporation, Dayton, 
    Ohio, 1994, 100 pp. [Copies of this publication may be purchased 
    from The Mazer Corporation, 2501 Neff Road, Dayton, Ohio 45414; 
    telephone (513) 276-6181.]
        Clydesdale, Fergus M., ed.: Workshop on the Evaluation of the 
    Nutritional and Health Aspects of Sugars, Proceedings of a Workshop 
    Held in Washington, D.C., May 2-5, 1994, ``Supplement to The 
    American Journal of Clinical Nutrition,'' vol. 62(1S):161S-296S, 
    July 1995. [Copies of this publication may be purchased from ``The 
    American Journal of Clinical Nutrition,'' 9650 Rockville Pike, 
    Bethesda, Maryland 20814-3998; fax (301) 571-8303.]
        National Research Council, Committee on Diet and Health: ``Diet 
    and Health: Implications for Reducing Chronic Disease Risk,'' 
    National Academy Press, Washington, D.C., 1989, 749 pp. [Copies of 
    this publication may be purchased from the National Academy Press, 
    2101 Constitution Avenue, N.W., Washington, D.C. 20418; telephone 1-
    800-624-6242 or (202) 334-3313.]
        U.S. Department of Agriculture, Agricultural Research Service, 
    Dietary Guidelines Advisory Committee: ``Report of the Dietary 
    Guidelines Advisory Committee on the Dietary Guidelines for 
    American, 1995: To the Secretary of Health and Human Services and 
    the Secretary of Agriculture,'' U.S. Government Printing Office, 
    Washington, D.C., September 1995, 58 pp. [Copies of this publication 
    may be purchased from the National Technical Information Service, 
    5285 Port Royal Road, Springfield, Virginia 22161; telephone (703) 
    487-4650.]
        U.S. Department of Agriculture, Food and Nutrition Service: 
    ``WIC Food Package and Nutrition Risk Criteria Reviews: Final 
    Report,'' U.S. Government Printing Office, Washington, D.C., 1991-
    1992, 3 volumes, 300 pp. (approximate). [This report to Congress is 
    comprised of the following three separate documents: (1) ``1992 
    Biennial Report on the Supplemental Food Program for Women, Infants, 
    and Children and on the Commodity Supplemental Food Program'' (NAL 
    call number aHV696.F6U625), prepared by the National Advisory 
    Council on Maternal, Infant and Fetal Nutrition; (2) ``Technical 
    Papers: Review of the WIC Food Packages'' (NAL call number 
    aHV696.F6T42 1991), prepared by the Department of Nutrition, College 
    of Health and Human Development, Pennsylvania State University, 
    under Cooperative Agreement Number 58-3198-1-006; and (3) 
    ``Technical Papers: Review of WIC Nutritional Risk Criteria'' (NAL 
    call number aHV696.F6T425 1991), prepared by the Department of 
    Family and Community Medicine, College of Medicine, University of 
    Arizona, under Cooperative Agreement Number 58-3198-1-005. The 
    Department sent copies of the complete report to all WIC State 
    agencies in 1992. Copies of the report may be borrowed from the 
    National Agricultural Library (NAL) using the NAL call numbers 
    listed above corresponding to the three component documents. State 
    and local staff of certain USDA programs may borrow materials 
    directly from NAL. Others may borrow materials from NAL through the 
    interlibrary loan system, making arrangements with their local or 
    corporate libraries. To borrow these documents, contact: NAL, 
    Document Delivery Services Branch, 10301 Baltimore Boulevard, 
    Beltsville, Maryland 20705-2351; telephone (301) 504-5755; fax (301) 
    504-5675.]
        U.S. Department of Agriculture, Food and Nutrition Service: 
    ``WIC Program Report to Congress: Nutritional Risk Criteria and Food 
    Package Reviews,'' Alexandria, Virginia, July 1991, 29 pp. [This 
    report constitutes a combination of two of the Department's reports 
    to Congress: a preliminary report on the WIC food package review and 
    an interim report on the WIC nutritional risk criteria review. The 
    Department sent copies of this report to all WIC State agencies in 
    1991. Copies of this report may be obtained by contacting: Food and 
    Nutrition Information Center (FNIC), NAL, 10301 Baltimore Boulevard, 
    Room 304, Beltsville, Maryland 20705-2351; telephone (301) 504-5719; 
    fax (301) 504-6409. Also, an electronic copy of the report is 
    available via the Internet at fnic@nalusda.gov.]
        U.S. Department of Agriculture, Food and Nutrition Service: WIC 
    Program: Report to Congress on Cereals Containing Fruit in the WIC 
    Supplemental Food Packages,'' Alexandria, Virginia, December 1991, 
    12 pp. [The Department sent copies of this report to all WIC State 
    agencies in January 1992. Copies of this report may be obtained by 
    contacting: FNIC, NAL, 10301 Baltimore Boulevard, Room 304, 
    Beltsville, Maryland 20705-2351; telephone (301) 504-5719; fax (301) 
    504-6409. Also, an electronic copy of report is available via the 
    Internet at fnic@nalusda.gov.]
        U.S. Department of Agriculture and U.S. Department of Health and 
    Human Services: ``Nutrition and Your Health: Dietary Guidelines for 
    Americans,'' 4th ed., Home and Garden Bulletin No. 232, U.S. 
    Government Printing Office, Washington, D.C., December 1995, 43 pp. 
    [For a single copy of the bulletin, send your name and address along 
    with
    
    [[Page 10905]]
    
    a check or money order for 50 cents payable to the Superintendent of 
    Documents to: Consumer Information Center, Department 378-C, Pueblo, 
    Colorado 81009. Also, an electronic copy of the bulletin can be 
    downloaded via the Internet/World Wide Web from the Home Page of the 
    USDA Center for Nutrition Policy and Promotion at http://
    www.usda.gov/fcs/cnpp.html or from the Food and Consumer Service 
    Bulletin Board at FedWorld. FedWorld may be accessed via a modem or 
    the Internet. If using a modem, set the modem parity to none, data 
    bits to 8, and stop bit to 1. Set terminal emulation to ANSI. Set 
    duplex to full, and then set communication software to dial FedWorld 
    at 703-321-3339. If using the Internet, you can either telnet to 
    fedworld.gov or ftp to ftp.fedworld.gov. After connecting to 
    FedWorld, select option D, ``Health, Safety and Nutrition Mall,'' 
    from the main menu, then choose option C, Food and Consumer 
    Service.]
        Willis, Judith Levine: ed.: ``An FDA Consumer Special Report: 
    Focus on Food Labeling,'' Food and Drug Administration, U.S. Public 
    Health Service, Department of Health and Human Services, Rockville, 
    Maryland, May 1993, 64 pp. [Copies of this publication may be 
    purchased from the Superintendent of Documents, U.S. Government 
    Printing Office, P.O. Box 371954, Pittsburgh, Pennsylvania 15250-
    7954.]
    
    Background
    
        Federal regulations at 7 CFR 246.10 require that a WIC-eligible 
    adult cereal be high in iron and low in sugar. The current WIC 
    regulations state that WIC-eligible adult cereals (hot or cold) must 
    contain a minimum of 28 milligrams of iron per 100 grams of dry cereal 
    and contain no more than 21.2 grams of sucrose and other sugars per 100 
    grams of dry cereal (i.e., 6 grams of sugar per dry ounce of cereal). 
    This Notice focuses only on the Department's consideration of changing 
    the sugar limit, not the iron requirement, for such cereals.
        There are currently five WIC food packages designed for different 
    participant categories that include the 6-gram sugar limit for WIC-
    eligible adult cereals. These WIC food packages are: Food Package III 
    for children/women with special dietary needs; Food Package IV for 
    children 1 up to 5 years of age; Food Package V for pregnant and 
    breastfeeding women (basic); Food Package VI for nonbreastfeeding 
    postpartum women; and Food Package VII for breastfeeding women 
    (enhanced).
        The basis for Federal regulation of the sugar content of WIC-
    eligible adult cereals is three-fold. First, Section 3 of Public Law 
    (P.L.) 95-627, enacted November 10, 1978, amended Section 17(f)(12) of 
    the Child Nutrition Act of 1966 [42 USC 1786(f)(12)] to say, ``[t]o the 
    degree possible, the Secretary [of Agriculture] shall assure that the 
    fat, sugar, and salt content of the prescribed [WIC] foods is 
    appropriate. * * *'' Second, the Department has been responsive to the 
    advice it has received from nutrition and health experts, the WIC 
    community and the general public over the years concerning the initial 
    establishment and continued retention of a sugar limit for WIC-eligible 
    adult cereals. Third, the Department recognized that dental caries is a 
    major public health problem in the United States (U.S.) and that sugars 
    in foods play a role in the development of dental caries.
        The Federal requirements for WIC-eligible cereals have been issues 
    of discussion since the early development of WIC food package 
    regulations. The initial legislation for the WIC Program enacted 
    September 26, 1972 (P.L. 92-433) did not impose a Federal sugar limit 
    for WIC-eligible adult cereals. However, in response to an interim rule 
    published January 12, 1976 (41 FR 1743) to implement provisions of P.L. 
    94-105, a significant number of commenters objected to the level of 
    sugar in cereals allowable by WIC Program regulations. This sentiment 
    was cited in the preamble of the proposed rule published February 11, 
    1977 (42 FR 8647) in response to the comments engendered by the January 
    12, 1976 interim rule. Although in that rulemaking the Department 
    proposed no restrictions on the sugar content of WIC-eligible adult 
    cereals, State agencies were reminded that they were not required to 
    offer cereals high in sugar, but could restrict eligible cereals to 
    those low in sugar (42 FR at 8649).
        In June 1977, the Department held public hearings in seven cities 
    to solicit oral and written testimony and suggestions for possible 
    changes in the WIC Program. A number of commenters at the hearings 
    favored USDA setting a maximum level for the amount of sugar allowed in 
    WIC-eligible cereals for children and women. The preamble of the final 
    regulations published August 26, 1977 (42 FR 43206) to revise and 
    reorganize the Program referenced this public response and solicited 
    further public comments on the issue of the Federal requirements for 
    WIC-eligible adult cereals.
        In October 1978, USDA convened a food package advisory panel 
    composed of representatives of WIC State agencies, the food industry, 
    the nutrition community, advocacy groups, and WIC participants. This 
    panel reviewed in depth the public comments on cereal issues which the 
    Department received in response to the August 26, 1977 final rule. The 
    Department received 230 comments on the exclusion of high-sugar cereals 
    for the WIC food packages. Over 90 percent of the comments (i.e., 208) 
    were in support of the Department establishing a maximum level of sugar 
    for cereals authorized in the WIC Program. As part of its 
    deliberations, the panel recommended a 6-gram sugar limit for use with 
    WIC-eligible adult cereals. The 6-gram sugar limit represented a 
    moderate sugar content for cereals on the market at that time. In 
    response, USDA published a proposed rule on November 30, 1979 (44 FR 
    69254) proposing a 6-gram sugar limit for WIC-eligible adult cereals.
        Of the 643 persons who commented on the proposed 6-gram sugar 
    limit, 542, primarily representing the nutrition and health care 
    communities, supported the 6-gram sugar limit or recommended a more 
    stringent one. Some of the reasons cited for supporting this 
    requirement were: the association between sugar consumption and dental 
    caries; recommendations in the 1979 ``Healthy People: The Surgeon 
    General's Report on Health Promotion and Disease Prevention,'' and in 
    the National Research Council's ``Recommended Dietary Allowances,'' 
    ninth edition, 1980, stating that sugar consumption by the U.S. 
    population should be reduced; and knowledge that highly sugared cereals 
    tended to be more expensive than cereals containing less sugar.
        The balance of 101 commenters, including 14 State and 53 local WIC 
    agencies, the Sugar Association and several cereal companies were 
    opposed to the 6-gram limit, or in some cases any sugar limit 
    whatsoever. Examples of the reasons given for opposing views were: the 
    opinion that the 6-gram sugar limit was chosen in an arbitrary and
    
    [[Page 10906]]
    
    capricious manner; an absence of a specific sugar limit in the USDA 
    regulation applicable to ``foods of minimum nutritional value'' sold in 
    competition with school lunches and breakfasts (7 CFR 210.11 and 
    220.12); and the lack of a clear cut-off point to differentiate low-
    sugar cereals from high-sugar cereals.
        After taking into consideration the advice from outside experts, 
    advisory groups and the majority of commenters as well as factors 
    relevant to the WIC Program (e.g., participant acceptance, versatility, 
    cost, and nutrition education efforts to improve eating habits), the 
    Department published a final rule on November 12, 1980 (45 FR 74854). 
    This rule established the 6-gram sugar limit for WIC-eligible adult 
    cereals.
        More recently in 1989, Section 123(c) of P.L. 101-147 mandated that 
    the Secretary conduct a review of WIC food packages to determine the 
    appropriateness of WIC-eligible foods. Among other things, the review 
    was to include consideration of: (1) how effectively protein, calcium 
    and iron are provided to participants; (2) the nutrient density of 
    foods; and (3) the extent to which nutrients, for which program 
    participants are most vulnerable to deficiencies, such as thiamine, 
    riboflavin, vitamin A and zinc, are effectively provided to 
    participants. Again, USDA formally solicited public comments on whether 
    there was evidence to support or refute the regulatory limit on the 
    amount of sugar contained in WIC food packages [55 FR 42856, October 
    24, 1990; 55 FR 52050, December 19, 1990].
        Of the 97 comment letters the Department received specifically 
    addressing the issue of whether the existing regulatory limits/
    requirements on components of the WIC foods should be retained, 66 
    comments supported retaining the 6-gram sugar limit for WIC-eligible 
    adult cereals. Twenty commenters suggested that this sugar limit be 
    retained only for WIC participants with weight problems, three industry 
    commenters opposed retaining this sugar limit and suggested either 
    removing or increasing it, and eight other commenters neither supported 
    nor opposed the sugar limit.
        On October 3, 1991, the Conference Report (H. Rep. No. 239, p.47) 
    accompanying P.L. 102-142, the Agriculture, Rural Development, Food and 
    Drug Administration, and Related Agencies Appropriations Act, 1992, 
    expressed the desire of the conferees that the Department ``make a 
    report to the appropriate committees of Congress on the issue of 
    cereals containing fruit in the WIC food package by December 31, 
    1991.'' In response, on December 31, 1991, the Department submitted to 
    pertinent Congressional committees a report that documented USDA's 
    broad base of support for retaining the 6-gram sugar limit. Included 
    among the letters USDA received encouraging the Department to retain 
    this WIC cereal requirement were those from the following non-profit 
    public interest groups and professional nutrition, medical and other 
    health-related organizations: American Academy of Pediatrics; American 
    Association of Public Health Dentistry; American Dental Association; 
    American Public Health Association; Association of State and 
    Territorial Dental Directors; Association of State and Territorial 
    Public Health Nutrition Directors; Bread for the World; Center for 
    Science in the Public Interest; Food Research and Action Center; 
    National Association of WIC Directors; National Parent-Teacher 
    Association; Public Voice for Food and Health Policy; and Society for 
    Nutrition Education.
        In 1992, the Department submitted the formal report to Congress on 
    the outcome of the WIC food package review required by P.L. 101-147, 
    Section 123(c). Based upon advice from the majority of commenters, 
    including numerous nutrition and health authorities, the Department 
    decided to retain the 6-gram sugar limit for WIC-eligible adult 
    cereals. The National Advisory Council on Maternal, Infant and Fetal 
    Nutrition also endorsed the 6-gram sugar limit in its 1992 Biennial 
    Report to the President and Congress. The Council was established in 
    1975 by Section 17 (h)(1) [currently 17(k)(1)] of the Child Nutrition 
    Act, and is composed of health/medical experts and representatives of 
    WIC agencies, parent participants, and food retailers, to advise USDA 
    on how to improve WIC operations.
        Also relevant to this issue is the publication ``Nutrition and Your 
    Health: Dietary Guidelines for Americans,'' jointly developed by USDA 
    and the U.S. Department of Health and Human Services (DHHS). The 
    ``Dietary Guidelines'' provide nutritional and dietary advice for the 
    general public (i.e., healthy Americans 2 or more years of age), based 
    upon the preponderance of current scientific and medical knowledge. The 
    first ``Dietary Guidelines'' were published in 1980 and have been 
    updated every five years to incorporate the latest research findings. 
    The updates are based on the recommendations of the 11-member Dietary 
    Guidelines Advisory Committee. This Committee is composed of widely 
    recognized non-Federal nutrition and medical experts. Similar to past 
    editions, the 1995 or fourth edition of the ``Dietary Guidelines,'' 
    released by USDA and DHHS on January 2, 1996, urges Americans to choose 
    a diet moderate in sugars. An excerpt from pages 33 and 34 of this 
    latest edition follows:
    
        For very active people with high calorie needs, sugars can be an 
    additional source of energy. However, because maintaining a 
    nutritious diet and a healthy weight is very important, sugars 
    should be used in moderation by most healthy people and sparingly by 
    people with low calorie needs. This guideline cautions about eating 
    sugars in large amounts and about frequent snacks of foods and 
    beverages containing sugars that supply unnecessary calories and few 
    nutrients.
    
        Over the past several years, the Department has received inquiries 
    from members of Congress and representatives of the food industry about 
    the scientific basis for continuing the present sugar limit for WIC-
    eligible adult cereals. Although clinical evidence continues to support 
    the correlation between sugar and dental caries, it has further 
    revealed that the consumption of any fermentable carbohydrate, 
    representing starches as well as sugars, can contribute to the 
    incidence of dental caries. In contrast, recent research has shown that 
    the independent factor of sugar intake does not appear to increase 
    one's risk of developing coronary heart disease, diabetes mellitus, 
    obesity, and hyperactivity.
        While this evidence may suggest that no specific nutritional risk 
    warrants a limit on sugar content, the Department recognizes that there 
    may be other reasons that make such a limit appropriate. Factors that 
    should be considered are any impact on the cost of the food package, 
    the need to promote good dietary habits among nutritionally at-risk 
    participants, and the potential that a change in the limit may permit 
    ``foods * * * containing sugars that supply unnecessary calories and 
    few nutrients'' to be included in the WIC food packages. The Department 
    also remains cognizant of the important role the WIC competent 
    professional authority plays in tailoring both the WIC food packages 
    and nutrition counseling to meet individual needs of Program 
    participants.
        Therefore, the Department is seeking public input on whether a 
    change in the 6-gram sugar limit for WIC-eligible adult cereals is in 
    the best nutritional interests of WIC participants. The Department is 
    hoping to elicit a wide range of views from nutrition and health 
    experts, the WIC community, and other members of
    
    [[Page 10907]]
    the public at large to assist USDA in making a decision about this 
    issue.
    
    Issues for Comment
    
        The Department is interested in receiving public comments on 
    whether the current 6-gram sugar limit for WIC-eligible adult cereals 
    should be changed. The Department has identified several positions 
    related to this decision that commenters may wish to address. USDA 
    would like to know which, if any, of the following options would be 
    most appropriate for WIC food packages that make adult cereal 
    available:
         Retain the current 6-gram sugar limit unchanged, counting 
    all sugar, both naturally occurring and added, as part of the total 
    sugar content of the cereal.
         Set a new sugar limit, either higher or lower than the 
    current 6-gram level. If this option is selected, commenters should 
    specify a new sugar limit, e.g., grams of sugar per dry ounce of 
    cereal, and their justification for suggesting a new limit.
         Revise the 6-gram sugar limit to represent only the amount 
    of sugar added during the manufacturing of a cereal, representing 
    either a separate ingredient (e.g., table sugar, corn syrup, brown 
    sugar, honey, and maltodextrin) or a separate component of a processed 
    or man-made ingredient (e.g., marshmallow and caramel), and exclude the 
    naturally occurring, inherent sugar in the cereal (e.g., sugars in 
    grains, dried fruits, and nonfat dry milk).
         Eliminate the Federal sugar limit for WIC-eligible adult 
    cereals. However, WIC State agencies would have the authority to 
    establish and enforce a sugar limit of their own for WIC-eligible adult 
    cereals approved for use in their respective States.
        Commenters are also invited to recommend alternative options not 
    stated above. In order for comment letters to be most useful to the 
    Department, commenters are urged to discuss both the pros and cons of 
    their recommendations as they apply to WIC participants and program 
    operations, including any problems WIC State agencies may encounter in 
    implementing a proposed alternative option. USDA is very interested to 
    know how any change might impact the provision and effect of WIC food 
    benefits and nutrition education. The Department also would like to 
    know whether WIC State and local agencies believe that the current 6-
    gram limit provides an adequate range of choices for both WIC agencies 
    and participants, consistent with the nutritional purposes of the WIC 
    Program.
    
        Dated: March 8, 1996.
    William E. Ludwig,
    Administrator, Food and Consumer Service.
    [FR Doc. 96-6178 Filed 3-15-96; 8:45 am]
    BILLING CODE 3410-30-P
    
    

Document Information

Published:
03/18/1996
Department:
Food and Consumer Service
Entry Type:
Proposed Rule
Action:
Notice of intent to propose rulemaking and solicitation of comments.
Document Number:
96-6178
Dates:
To be assured of consideration, comments must be received on or before June 17, 1996.
Pages:
10903-10907 (5 pages)
PDF File:
96-6178.pdf
CFR: (1)
7 CFR 246