61476 Federal Register / Vol. 62, No. 222 / Tuesday, November 18, 1997 / Proposed Rules

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.

Proposed Standard No. 57B Fuel

encompasses, but is not limited to, the energy

consumed in providing the transportation

service (i.e. natural gas, fuel oil, propane,

electricity) and lost and unaccounted for gas.

Proposed Standard No. 58 For cash-out as

the fuel reimbursement method, Service

Requester should notify Service Provider of

its election to exercise the cash-out option for

fuel one day prior to the close of the NYMEX

natural gas futures trading for the next

calendar month.

Proposed Standard No. 59B Where cashout, as a fuel reimbursement method, is

offered as an option by a Service Provider,

the Service Requester should notify Service

Provider of its election to exercise the cashout option for fuel one day prior to the close

of the NYMEX natural gas futures trading for

the next calendar month.

Proposed Standard No. 60 Fuel Cash-out

options should be exercised for a minimum

of one calendar month.

Proposed Standard No. 61 Fuel Cash-out

quantities should be determined by

multiplying allocated receipts by fuel

percentages as stated in the tariff or

applicable contract(s).

Proposed Standard No. 62 Fuel Cash-out

price should be an established commodity

market price (i.e. index or competitive bid)

in rate area, zone or segment of the activity,

or be based on the same fuel cash-out index

used for imbalances.

Proposed Standard No. 63 The fuel cashout value (fuel quantities times fuel cash-out

price) should be separately stated on the

invoice for the related activity.

Proposed Standard No. 64 If fuel cash-out

price is index-based, the determination of the

applicable indices should based on the

approved tariff provisions or applicable

contract(s).

Proposed Standard No. 65 If fuel cash-out

price is other than index-based, the Service

Provider should post that price three days

prior to the close of the NYMEX natural gas

futures trading for the next calendar month.

Proposed Standard No. 66B There should

be no cross-subsidization by Service

Providers of fuel provision service(s) by

transportation service(s) when both fuel

provision services and transportation

services are provided by the service provider.

Proposed Standard No. 67 Negotiated

fuel gas sales are sales of gas by the service

provider for the use of the service requester

as fuel for its transportation transaction. The

price and terms and conditions applicable to

the sales transaction should be negotiated

between the transportation service provider

and the service requester.

Proposed Standard No. 95A If negotiated

fuel gas sales are offered, all transportation

terms, conditions applicable to fuel sales

service should be specified in the

transportation service providers tariff, if

applicable.

Intraday Nominations

Proposed Standard No. 77A Intraday

nominations should be allowed at all

nominatable receipt and delivery points and

at pooling points.

OBAs and Imbalances

Proposed Standard No. 85A All

transportation service providers who have

sufficient system storage should allow

service requesters (in this instance, service

requester excludes agents) to net similarly

situated imbalances on and across contracts

with the transportation service provider

among themselves. In this context, ‘‘similarly

situated imbalances’’ includes contracts with

the substantially similar financial and

operational implications to the transportation

service provider.

Proposed Standard No. 88A Imbalance

penalties should be based on the lesser of the

imbalance penalties based on operationally

provided measurement/allocated data and

actual measurement/allocated data.

[FR Doc. 97–30233 Filed 11–17–97; 8:45 am]

BILLING CODE 6717–01–P

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.

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
Federal Register / Vol. 62, No. 222 / Tuesday, November 18, 1997 / Proposed Rules 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).

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

§ 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

§ 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 (§ 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’’) (§ 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) (§ 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.’’
61478 Federal Register / Vol. 62, No. 222 / Tuesday, November 18, 1997 / Proposed Rules

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

(§ 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

(§ 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 (§ 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 § 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
Federal Register / Vol. 62, No. 222 / Tuesday, November 18, 1997 / Proposed Rules 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 § 101.9(j)(18) (59 FR

11872, March 14, 1994). As of May

1997, proposed § 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
61480 Federal Register / Vol. 62, No. 222 / Tuesday, November 18, 1997 / Proposed Rules

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 § 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 § 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 § 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

21 CFR Section No. of

Respondents

Total No. of ResponsesHours per

Response Total Hours OperatingCosts

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

1There 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:

§ 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
Federal Register / Vol. 62, No. 222 / Tuesday, November 18, 1997 / Proposed Rules 61481

‘‘Product category’’ column, under the

‘‘Miscellaneous Category’’ by revising

the entry for ‘‘Baking powder, baking

soda, pectin’’ to read as follows:

§ 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 .................................................. ll tsp (llg).

* * * * * * *

1These 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. 5The 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 § 101.9(b) using the reference amount determined according to § 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

POSTAL SERVICE

39 CFR Part 232

Conduct on Postal Service Property

AGENCY: Postal Service.

ACTION: Proposed rule.

SUMMARY: This proposed rule will

amend United States Postal Service

property regulations to: prohibit

smoking in postal buildings; prohibit

soliciting of signatures on petitions,

polls, or surveys on postal property

except as otherwise authorized by Postal

Service regulations; prohibit impeding

ingress to or egress from post offices;

add regulations for voter registration

activities on postal property to reflect

current postal policy; prohibit leafleting,

picketing, demonstrating, public

assembly, and public address in lobbies

and other interior areas of postal

buildings open to the pubic; prohibit

placement of tables, chairs, freestanding

signs or posters, structures, or furniture

of any type on postal property except as

part of postal activities or as otherwise

permitted by these regulations; permit,

in addition to seeing eye dogs, other

animals used to assist persons with

disabilities on postal property; prohibit

the storage of weapons and explosives

on postal property except for official

purposes; clarify the meaning of terms;

change references to other postal

directives; and provide that persons

designated by the Chief Postal Inspector

may also enforce Postal Service property

regulations.

DATES: Comments must be received on

or before December 18, 1997.

ADDRESSES: Written comments should

be mailed or delivered to the

Independent Counsel, Postal Inspection

Service, 475 L’Enfant Plaza SW, Room

3411, Washington, DC 20260–2181.

FOR FURTHER INFORMATION CONTACT:

Henry J. Bauman, Independent Counsel,

Postal Inspection Service, (202) 268–

4415.

SUPPLEMENTARY INFORMATION: Postal

Service regulations on the conduct of

persons on postal property are

published in title 39 of the Code of

Federal Regulations (CFR) as part 232.

These regulations describe the actions

that are either permitted or proscribed,

the enforcement of these regulations,

and the penalties for violations. The

purpose of this proposed rule is to

amend these regulations to add new

prohibitions, to add regulations for voter

registration activities on postal property,

to permit animals used to assist persons

with disabilities to be brought onto

postal property, and to clarify certain

terms and references in the regulations.

A new prohibition on smoking in

postal lobbies and offices is proposed to

address the health concerns of postal

customers and employees. The reasons

for this prohibition are that the Surgeon

General has reported on the dangers to

human health from smoking and

second-hand smoke, the sale of tobacco

products is prohibited in other federal

buildings, the Postal Service has already

banned smoking in postal buildings by

postal employees, and many post offices

have banned smoking in lobbies and

other interior areas open to the public.

A new prohibition on the soliciting of

signatures on petitions, polls, or surveys

on postal property, except as otherwise

authorized by Postal Service

regulations, is proposed. The purpose of

this restriction is to minimize the

disruption of postal business and to

provide unimpeded ingress and egress

of customers and employees to and from

post offices. Portions of the existing

Postal Service conduct regulations have

been upheld by the Supreme Court in

United States v. Kokinda, 497 U.S. 720

(1990). The United States Postal Service

was created in order to ensure prompt,

reliable, and efficient postal services to

the public in a businesslike manner. It

is the Postal Service’s experience that

the activities described above are

generally disruptive to postal business.

Thus, the Postal Service is prohibiting