[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 [email protected].]
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 [email protected].]
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]
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