[Federal Register Volume 62, Number 222 (Tuesday, November 18, 1997)]
[Proposed Rules]
[Pages 61476-61481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94P-0240]
Food Labeling; Serving Sizes; Reference Amount for Baking Powder,
Baking Soda, Pectin
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the nutrition labeling regulations to change the reference amount
customarily consumed per eating occasion for the food category ``baking
powder, baking soda, pectin'' from 1 gram (g) to 0.6 g to more
accurately reflect the amount of these products that is customarily
consumed. The agency is also proposing to include 1/8 teaspoon (tsp) as
an additional allowable household measure because it is a common
household measure available to consumers. The agency is proposing this
action in response to a petition filed by Arm & Hammer.
DATES: Submit written comments by February 2, 1998. See section IV of
this document for the proposed effective date of a final rule based on
this document. Submit written comments on the collection of information
requirements by December 18, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
Submit written comments on the information collection requirements
to the Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), New Executive Office Bldg., 725 17th St.
NW., rm. 10235, Washington, DC 20503, ATTN: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5662.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 19, 1990 (55 FR 29517), FDA
proposed standard serving sizes for 159 food product categories based
on the amount of food commonly consumed per eating occasion by infants,
toddlers (children under 4 years of age), and the general population
(persons 4 years of age or older). FDA did not suggest any specific
serving size for baking soda, baking powder, or pectin at that time.
On November 8, 1990, before FDA issued a final rule on serving
sizes, Congress passed the Nutrition Labeling and Education Act of 1990
(hereinafter referred to as ``the 1990 amendments''). Section 2a of the
1990 amendments added section 403(q)(1)(A)(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 343(q)(1)(A)(i)) to require
that virtually all foods under FDA's jurisdiction bear nutrition
information that is based on a serving size which reflects the amount
of food that is customarily consumed and which is expressed in a common
household measure that is appropriate to the food. Section 2(b)(1)(B)
of the 1990 amendments also directed FDA to adopt regulations that
establish standards for defining serving sizes.
In response to the 1990 amendments, among other actions, FDA issued
a reproposal on serving sizes (56 FR 60394, November 27, 1991) and
asked for comments on all proposed reference amounts. In response to a
notice of public meeting, the agency received suggestions recommending
a serving size of ``1 tablespoon'' for baking powder, ``1 teaspoon''
for pectin, and no recommendation for baking soda. No consumption data
were provided for any of the three products (Ref. 1)\1\. In the
[[Page 61477]]
reproposal, FDA proposed a reference amount customarily consumed per
eating occasion (hereinafter referred to as ``reference amount'') of 1
g for ``Baking powder, baking soda, pectin'' (56 FR 60394 at 60419),
stating that, although no appropriate food consumption data were
available, the agency tentatively concluded that 1 g was reasonable for
the product category (Ref. 1).
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\1\ In this document, the agency is citing relevant material to
baking powder, soda, and pectin that originally appeared in Ref. 2
to the reproposal on serving sizes that appeared in the Federal
Register of November 27, 1991 (56 FR 60394), and Ref. 66 to the
final rule on serving sizes that appeared in the Federal Register of
January 6, 1993 (58 FR 2229 at 2296). (See Docket No. 90N-0165.) For
the convenience of the reader the materials are contained in ``Ref.
1'' of this document.
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The agency received no comments on the proposed reference amount
for baking powder, baking soda, and pectin. In the absence of data
supporting a different reference amount, FDA concluded, in its final
rule on serving sizes, that 1 g was the appropriate reference amount
for all products within this category (58 FR 2229 at 2296, January 6,
1993).
II. The Petition
FDA received a petition dated June 23, 1994, from Church Dwight
Co., Inc., on behalf of Arm & Hammer (94P-0240), requesting that the
agency amend Sec. 101.12, in Table 2, in paragraph (b), under
``Miscellaneous Category: Baking powder, baking soda, pectin'' to: (1)
Create a separate subcategory for baking soda; (2) establish a
reference amount of ``500 mg'' for baking soda; and (3) permit a
corresponding serving size of ``1/8 tsp (500 mg).''
The company provided an estimate of the average consumption of
baking soda based upon the amount of baking soda used in nine recipes.
Two of the recipes contained baking soda. For these two recipes, the
company calculated the amount of baking soda based on the reference
amount of the finished product. For the seven other recipes that
involved the use of baking powder, the company noted that approximately
30 percent of baking powder is baking soda and calculated the amount of
baking soda as 1/3 of the amount of baking powder, based on the
reference amount of the finished product. The company reported that the
average amount of baking soda consumed per reference amount was 261
milligrams (mg), with a range of 54 to 484 mg.
The company also provided documentation to support that 1/8 tsp
measuring spoons are common household measures that are available to
consumers.
Based on information provided in the petition and on FDA
calculations for products containing baking soda, baking powder, and
pectin, FDA is proposing to: (1) Include 1/8 tsp as an allowable
household measure; and (2) amend the reference amount for baking
powder, baking soda, and pectin from ``1 gram'' to ``0.6 grams.'' A
discussion of the basis for the agency's action on the petition and for
the proposed changes follows:
III. Basis for the Proposed Action
A. Consideration of an Additional Household Measure
Based on information provided in the petition and on an informal
survey of the marketplace (Ref. 1), FDA agrees with the petitioner that
1/8-tsp measuring spoons are now available to consumers. FDA located a
set of measuring spoons that included a 1/8-tsp measure and an
adjustable measuring spoon that could be varied to measure volumes from
1/8 to 1 tsp (Ref. 1). Therefore, for products that can be measured in
fractions of a teaspoon, the agency is proposing to amend
Sec. 101.9(b)(5)(i) (21 CFR 101.9(b)(5)(i)) to include 1/8 tsp as an
additional allowable household measure. FDA is also proposing to
reorganize this section to simplify the options for teaspoon and
tablespoon measures and to improve clarity.
B. Consideration of Revised Reference Amounts
1. Evaluation of the Appropriateness of the Data Supplied for Baking
Soda
FDA has two concerns with the approach to determining a reference
amount for baking soda taken in the petition. First, for the recipes
containing baking powder, the petitioner calculated the amount of
baking soda as a fraction of the amount of baking powder in the recipe.
However, baking soda and baking powder are distinct products. The
reference amount for baking soda must be based on the major intended
use of baking soda (Sec. 101.12(a)(7) (21 CFR 101.12(a)(7))), not a
fraction of the reference amount of baking powder.
The major consumer use of baking soda is as an ingredient in baked
goods, as evidenced by the number of recipes that provide for the use
of baking soda as an ingredient that are included in both the petition
(e.g., cookies, muffins) and in the 1987 to 1988 U.S. Department of
Agriculture (USDA) Recipe File (e.g., cornbread, quick breads, cakes,
cookies) (Ref. 1), when baking powder is unavailable, baking soda mixed
with cream of tartar may be substituted for baking powder (Ref. 1).
However, consumers do not commonly use baking soda to make baking
powder because: (1) Baking powder is a commonly available ingredient,
(2) substitution may not work in all cases (Ref. 1), and (3) some
recipes include both baking soda and baking powder as ingredients,
e.g., cake and cookie recipes, included in the petition, and quick
bread, cake, and cookie recipes, included in the 1987 to 1988 USDA
Recipe File (Ref. 1). Therefore, the consumption of baking soda cannot
be based upon the amount of baking soda contained in baking powder.
Second, the reference amounts provided for baked goods (e.g.,
biscuits, cornbread, muffins, quick breads, cakes, and cookies) are for
the finished product (i.e., ``baked'') (Sec. 101.12(b), footnote 2 in
Tables 1 and 2) and thus take into account changes in weight during
baking. To determine the amount of baking soda contained in one
reference amount of finished product, it is necessary to consider the
weight of the ingredient (i.e., baking soda) as a proportion of the
weight of the finished product (e.g., cake) rather than as a proportion
of the weight of the raw ingredients (e.g., cake batter) because the
reference amounts of baked goods are for the finished products (e.g.,
on a ready-to-serve or almost ready-to-serve basis) (Sec. 101.12(b),
footnote 2 in Table 2). To account for losses during cooking (e.g.,
moisture), the finished product weight is determined by applying a
yield factor to the sum of the weights of the raw ingredients. Yield
factors were provided by USDA as part of the Recipe File (Ref. 1) and
represent the final weight of the cooked recipe expressed as a
percentage of the uncooked weight (Ref. 1). The calculations used in
the petition were based on the weights of the ingredients before
baking, not on the weight of the finished product. Therefore, although
the difference in weight before and after baking would be expected to
be small, it is not appropriate to rely on the calculations provided by
the petitioner.
The petitioner only supplied information on the amounts of baking
soda contained in two recipes (0.142 g baking soda in one reference
amount of chocolate chip cookies, 0.326 g baking soda in one reference
amount of buttermilk muffins). As described previously, these values
contain minor calculation errors because they were based on the sum of
the weights of the ingredients rather than on the finished, cooked
weights of the cookies and muffins. FDA cannot calculate the correct
amounts of baking soda contained in these two products because the
finished weights were not provided. The correct values would be
expected to vary only slightly from those provided, however. Therefore,
the limited data provided suggest that the customary consumption of
baking soda is less than the reference amount of ``1 gram.''
[[Page 61478]]
2. Calculation of an Estimated Amount of Baking Powder and Baking Soda
Customarily Consumed Per Eating Occasion
Although the information provided by the petition is suggestive,
two recipes are insufficient to support a change in the reference
amount for baking soda. To determine whether a change in the reference
amount for baking soda is warranted, FDA independently evaluated data
for additional products containing baking soda. The agency also
evaluated data for baking powder, which currently has the same
reference amount as baking soda.
There are no direct consumption data available on baking soda and
baking powder because these products are consumed as part of baked
goods. Therefore, to estimate an appropriate reference amount, the
agency used a procedure similar to the one it used to develop a
reference amount for flour, and which it described in the reproposed
rule on serving sizes (Ref. 1). Because the major use of flour is to
make bread, FDA based the reference amount for flour on the amount
contained in one reference amount of white bread. The agency rounded
the calculated value down based on estimates of the amount of flour
required to make one reference amount of other common products
containing flour (e.g., cakes and cookies), which are somewhat lower
than the amount used to make bread.
For baking soda and baking powder, FDA reviewed recipes included in
the 1987 to 1988 USDA Recipe File (Ref. 1) and determined that there is
no one major use of baking soda or baking powder. Therefore, the agency
selected 20 baked products that are representative of the variety of
products containing baking powder, baking soda, or both (e.g., muffins,
cakes, cookies) (Ref. 1). Baking soda is an ingredient in 11 of the
recipes, and baking powder is an ingredient in 15 of the recipes.
FDA adjusted for moisture losses during baking and calculated the
amounts of baking powder and baking soda contained in a reference
amount of the various finished, cooked products (Ref. 1). FDA considers
that these calculated amounts indirectly reflect the amounts of baking
soda and baking powder customarily consumed when a reference amount of
one of these finished products is consumed. For example, the reference
amount for banana cake without icing is 125 g. This amount represents
the amount of banana cake customarily consumed per eating occasion. FDA
determined that 0.41 g of baking soda is contained in 125 g of banana
cake. Thus, 0.41 g of baking soda is customarily consumed as part of
the 125 g of banana cake.
The amounts of baking powder per reference amount in the 15
products that contain baking powder ranged from 0.13 g to 1.28 g (Ref.
1). For the 11 products containing baking soda, the amount of baking
soda contained ranged from 0.08 g to 1.05 g (Ref. 1). There is
considerable overlap in the amounts of baking soda and baking powder
customarily consumed as part of these baked good products.
The petitioner requested a subcategory for baking soda, separate
from baking powder and pectin. To support the creation of a separate
subcategory for baking soda, the data must demonstrate that the new
subcategory of food will be consumed in amounts that differ enough from
the reference amount for the parent category to warrant a separate
reference amount (Sec. 101.12(h)(11)(i)). The previous recipes
demonstrate that baking soda is not consumed in amounts that differ
enough from the amounts in which baking powder is consumed to warrant a
separate subcategory. Therefore, the agency is denying this aspect of
the petition.
Because the serving size is expressed in common household measures
(Sec. 101.9(b)(7)), FDA calculated the weights of baking soda and
baking powder that correspond to 1/4 tsp, the smallest household
measure currently permitted (Sec. 101.9(b)(5)(i)), and to 1/8 tsp, the
household measure suggested by the petitioner. The agency used a
standard value of 4.6 g/tsp reported by USDA for the density of baking
soda and baking powder (Ref. 1).
To determine whether the current reference amount of 1 g accurately
reflects the amounts of baking soda and baking powder customarily
consumed, FDA reviewed the calculated amounts of baking soda and baking
powder in the 20 representative baked good products. FDA found that,
among the 11 recipes that contained baking soda, the great majority
(10) of the values for baking soda clustered around 0.6 g (the weight
of 1/8 tsp), and that for only 1 product was the value for baking soda
closer to 1.2 g (the weight of 1/4 tsp) than to 0.6 g (Ref. 1). Of the
15 recipes containing baking powder, the agency again found that the
great majority of values (12) clustered around 0.6 g (the weight of 1/8
tsp), and that only 3 values for baking powder were closer to 1.2 g
(the weight of 1/4 tsp) than to 0.6 g (Ref. 1).
These data provide significant evidence that the current 1 g
reference amount, which approximates the weight of 1/4 tsp, is too
large for both baking soda and baking powder. They support that a ``0.6
g'' reference amount, which would result in a serving size declaration
of ``1/8 tsp,'' would more accurately reflect the amount of baking soda
and of baking powder contained in a reference amount of the prepared
products that contain these foods.
3. Consideration of a Different Reference Amount for Pectin
In the final rule on serving sizes (58 FR 2229 at 2296), FDA
included pectin in the same product category as baking soda and baking
powder. Because the agency is considering a different reference amount
for baking soda and baking powder (discussed in sections III.B.1 and
B.2 of this document), FDA also reevaluated the appropriateness of the
1 g reference amount for pectin.
Pectin is an ingredient that is used as a thickener in the
preparation of jams and jellies. The agency located one jam recipe
(Ref. 1) that gives the yield in a volume measure (cups), making it
possible to calculate the amount of pectin per reference amount of
prepared jam (1 tbsp) (Ref. 1). The agency's calculation reveals that 1
tbsp of jam contains 0.52 g of pectin (Ref. 1). The 1987 to 1988 USDA
Recipe File (Ref. 1) does not contain any recipes for jams or jellies,
and FDA does not have any other information on pectin. Though limited,
this one recipe supports a reference amount for pectin closer to 0.6 g
than to the current ``1 gram'' reference amount. FDA requests that
interested persons submit information on the appropriateness of this
reference amount for pectin.
C. Proposed Action
After reviewing the data on baking soda and baking powder use as
ingredients in various baked goods, and after considering the amount of
pectin in a reference amount of jam, the agency is proposing to change
the reference amount in Sec. 101.12(b), Table 2 for the ``Miscellaneous
Category: Baking powder, baking soda, pectin'' from ``1 g'' to ``0.6
g'' to better reflect the amounts customarily consumed for these
products.
IV. Effective Date
The agency periodically establishes by final rule in the Federal
Register uniform effective dates for compliance with food labeling
requirements (see, e.g., the Federal Register of December 27, 1996 (61
FR 68145)). FDA proposes that any final rule that may issue based upon
this proposal become effective in accordance with a uniform effective
date for compliance with food labeling requirements, which is
established by
[[Page 61479]]
final rule in the Federal Register and which is no sooner than 1 year
following publication of any final rule based upon this proposal.
The final rule would apply to affected products initially
introduced or initially delivered for introduction into interstate
commerce on or after its effective date. However, FDA notes that it
generally encourages industry to comply with new labeling regulations
as quickly as feasible. Thus, when industry members voluntarily change
their labels, it is appropriate that they incorporate any new
requirements that have been published as final regulations up to that
time. On the other hand, if any industry members can foresee that the
proposed effective date will create particular problems, they should
bring these problems to the agency's attention in comments on this
proposal.
V. Environmental Impact
The agency has determined under 25.32(p) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Executive Order 12866 Analysis
FDA has examined the economic implications of the proposed rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select the
regulatory approach which maximizes net benefits (including potential
economic, environmental, public health and safety effects; distributive
impacts; and equity). Executive Order 12866 classifies a rule as
significant if it meets any one of a number of specified conditions,
including having an annual effect on the economy of $100 million or
adversely affecting in a material way a sector of the economy,
competition, or jobs, or if it raises novel legal or policy issues. FDA
finds that this proposed rule is not a significant rule as defined by
Executive Order 12866.
This proposed rule will cause the labels of baking powder, baking
soda, and pectin to be revised. FDA estimates that there are 29 firms
producing baking powder, baking soda, or pectin. There are 23 baking
powder labels, 18 baking soda labels, and 25 fruit pectin labels for a
total of 66 labels affected by this rule. On average, the
administrative, redesign, and inventory disposal costs for a labeling
change of this type, with a 1-year compliance period are $600 per
product, or a total of $39,600.
The benefit of this proposed regulation is that because
manufacturers will provide information on a serving size that is more
appropriate for baking soda, baking powder, and pectin, product labels
will provide more accurate information to consumers.
VII. Regulatory Flexibility Analysis
FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
options that would minimize the economic impact of that rule on small
entities. Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the
agency certifies that this proposed rule will have a significant impact
on a substantial number of small entities.
A. Estimate and Description of the Small Entities
According to the Regulatory Flexibility Act, the definition of a
small entity is a business independently owned and operated and not
dominant in its field. The Small Business Administration has set size
standards for most business categories through use of four-digit
Standard Industrial Classification codes. For baking powder, baking
soda, and pectin, a business is considered small if it has fewer than
500 employees.
FDA estimates that four of the firms producing baking powder,
baking soda, or pectin are small. FDA also estimates that each small
firm produces two products which might be relabeled as a result of this
rule.
B. Description of the Impacts
The cost of this rule per small firm will be $1,200 ($600 x two
products). The 95th percentile firm has annual sales of $275,000 and
one employee. The costs of the rule as a percentage of annual sales is
0.4 percent. Return on sales for this industry is 8.3 percent for the
upper quartile, 2.9 percent for the median, and 0.9 percent for the
lower quartile. FDA is uncertain to which quartile this firm belongs
because the number of employees and annual sales do not imply anything
about the profitability of a firm. The costs of this rule will be 4.8
percent of profits if this firm falls into the upper quartile for the
industry, 13.8 percent of profits if this is a median firm, and 44.4
percent of profits if this firm falls into the lower quartile.
Therefore, the smallest 5 percent of affected firms will be adversely
affected by this rule. Under the Regulatory Flexibility Act (5 U.S.C.
605), the agency concludes that this proposed rule will have a
significant impact on a substantial number of small entities.
C. Compliance Requirements and Necessary Skills
The Regulatory Flexibility Act also requires agencies to describe
the projected reporting, recordkeeping, and other compliance
requirements of the rule and the type of professional skills necessary
for preparation of the report or record. Manufacturers of baking soda,
baking powder, and pectin will be required to amend their labels to
reflect the new serving sizes. Manufacturers must recalculate the
reported levels of nutrients in the foods based on the new serving
sizes. No further analyses are required, only that the reported amounts
are based on the correct serving size.
D. Alternatives
FDA has examined the following alternatives to the rule that may
minimize the significant economic impact on small entities consistent
with stated objectives.
1. Exempt Small Entities
The agency has adopted an exemption from mandatory nutrition
labeling for low-volume food products of small businesses in
Sec. 101.9(j)(18) (59 FR 11872, March 14, 1994). As of May 1997,
proposed Sec. 101.9(j)(18) applies to manufacturers, packers,
distributors, or retailers of low volume products, defined as fewer
than 100,000 units, produced by firms with fewer than 100 employees. To
the extent that baking powder, baking soda, or pectin products are
eligible for this exemption, they might not require relabeling as a
result of this rule. However, if the products are currently
nutritionally labelled either because the label contains nutrient
content claims or because the manufacturer has voluntarily labeled the
product, then the nutrition facts panel must be correct and the label
must be changed. FDA is uncertain how many firms, if any, can or will
take advantage of this option.
2. Lengthen the Compliance Period
FDA also considered the option of providing small entities with a
longer compliance period. If finalized, labels must be changed by the
appropriate Uniform Compliance Date. Depending on when the final rule
publishes, firms will have as little as 1 year or as much as 2 years to
complete labeling changes. Longer compliance periods typically result
in lower costs because firms can
[[Page 61480]]
combine mandated label changes with planned changes and because firms
have more opportunity to use up existing labels. A 2-year compliance
period would reduce costs to $200 per firm.
VIII. The Paperwork Reduction Act of 1995
This proposed rule contains information collection requirements
that are subject to review by OMB under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3520). The title, description, and respondent
description of the information collection requirements are shown below
with an estimate of the annual reporting and recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology.
Title: Serving Sizes; Reference Amount for Baking Powder, Baking
Soda, Pectin.
Description: Section 403(q)(1)(A) and (q)(1)(B) of the act requires
that the label or labeling of a food bear information that provides the
serving size that is appropriate to the food and the number of servings
per container. FDA has issued regulations in Sec. 101.9(d)(3) that
require the nutrition facts panel on the label of a food product
disclose information on serving size and on servings per container. FDA
has also issued regulations in Sec. 101.9(b) that provide that the
serving size declared on a product label shall be determined from the
``Reference Amounts Customarily Consumed Per Eating Occasion'' that
appear in Sec. 101.12(b).
The regulations set forth in this proposed rule would revise the
reference amount that is used for determining the serving sizes for
packages of baking powder, baking soda, and pectin. As a result,
manufacturers and other producers of these products would be required
to change the serving sizes and the number of servings per container
that they disclose in the nutrition facts panel for their products. The
proposed regulations would also provide for the use of 1/8 tsp as an
additional household measure for the disclosure of serving sizes for
food products.
Description of Respondents: Persons and businesses, including small
businesses.
Table 1.--Estimated Annual Reporting and Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
No. of Total No. of Hours per Operating
21 CFR Section Respondents Responses Response Total Hours Costs
----------------------------------------------------------------------------------------------------------------
101.12(b) 29 66 1 66 $39,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or maintenance costs associated with this collection.
FDA believes that the burden associated with the disclosure on the
label of serving size and number of servings that would be required by
this proposed rule will be a one-time burden created by the need for
firms to have to change the statement of serving size and number of
servings on the labels for their products. As noted previously, FDA
estimates that there are 29 firms producing baking powder (23 labels),
baking soda (18 labels), and pectin (25 labels). FDA estimates that
these firms will require an average of 1 hour per product to comply
with the requirements of a final rule based on this proposal. Further,
as noted previously, the proposed rule would result in a one-time
operating cost of $39,600.
In compliance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information
collection requirements of the proposed rule to OMB for review.
Interested persons are requested to send comments regarding information
collection by December 18, 1997, to the Office of Information and
Regulatory Affairs, OMB (address above), ATTN: Desk Officer for FDA.
IX. Comments
Interested persons may, on or before February 2, 1998, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
X. References
The following reference has been placed on public display in the
Dockets Management Branch (address above) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. LeGault, Lori A., Susan K. Brecher, and Ellen M. Anderson,
memorandum to file, August 20, 1997.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
2. Section 101.9 is amended by revising paragraph (b)(5)(i) to read
as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(b) * * *
(5) * * *
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate except for beverages. For beverages, a manufacturer may
use fluid ounces. Cups shall be expressed in 1/4- or 1/3-cup
increments. Tablespoons shall be expressed as 1, 1 1/3, 1 1/2, 1 2/3,
2, or 3 tablespoons. Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/
4, 1, or 2 teaspoons.
* * * * *
3. Section 101.12 is amended in paragraph (b), in Table 2, under
the
[[Page 61481]]
``Product category'' column, under the ``Miscellaneous Category'' by
revising the entry for ``Baking powder, baking soda, pectin'' to read
as follows:
Sec. 101.12 Reference amounts customarily consumed per eating
occasion.
* * * * *
(b) * * *
Table 2.--Reference Amounts Customarily Consumed per Eating Occasion: General Food Supply 1, 2, 3, 4
----------------------------------------------------------------------------------------------------------------
Product category Reference amount Label statement5
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Miscellaneous Category:
Baking powder, baking soda, pectin.. 0.6 g ____ tsp (____g)
* * * * * *
*
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\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the
U.S. Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or
almost ready-to-serve form of the product (i.e, heat and serve, brown and serve). If not listed separately,
the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; fresh and frozen
pasta) is the amount required to make the reference amount of the prepared form. Prepared means prepared for
consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the label serving size in a household measure
most appropriate to their specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington,
DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers on the presentation of serving size
information on the label, but they are not required. The term ``piece'' is used as a generic description of a
discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific
product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided
is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not
apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless
specifically stated in the product category, reference amount, or label statement column that it is for these
forms of the product. For products that require further preparation, manufacturers must determine the label
statement following the rules in Sec. 101.9(b) using the reference amount determined according to Sec.
101.12(c).
* * * * *
Dated: October 29, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-30272 Filed 11-17-97; 8:45 am]
BILLING CODE 4160-01-F
