Food Labeling; Serving Sizes; Reference Amount for Baking Powder, Baking Soda, Pectin

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

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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

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No. of Total No. of Hours per Operating

21 CFR Section Respondents Responses Response Total Hours Costs

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101.12(b) 29 66 1 66 $39,600

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\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

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Product category Reference amount Label statement5

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* * * * * *

*

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