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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending 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 including 1/8 teaspoon (tsp) as an

additional allowable household measure, because it is a common

household measure available to consumers. This action is being taken in

response to a petition submitted by Church Dwight Co., Inc., on behalf

of Arm & Hammer.

DATES: Effective January 1, 2002. Full compliance is required for all

affected products initially introduced or initially delivered for

introduction into interstate commerce on or after January 1, 2002.

Voluntary compliance may begin April 15, 1999.

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 November 18, 1997 (62 FR 61476), FDA

published a proposed rule 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 g

to 0.6 g to more accurately reflect the amount of these products that

is customarily consumed. The agency also proposed to include 1/8 tsp as

an additional allowable household measure because it is a common

household measure available to consumers. Interested persons were given

until February 2, 1998, to comment on the proposal.

FDA had issued the proposal in response to a petition dated June

23, 1994, from Church Dwight Co., Inc., on behalf of Arm & Hammer (94P-

0240). The petitioner requested that the agency amend Table 2 in

Sec. 101.12(b) (21 CFR 101.12(b)) under ``Miscellaneous Category:

Baking powder, baking soda, pectin'' to create a separate subcategory

for baking soda with a reference amount of ``500 milligrams (mg)'' and

to permit a corresponding serving size of ``1/8 tsp (500 mg)'' (which

would require amending Sec. 101.9(b)(5)(i) (21 CFR 101.9(b)(5)(i)).

II. Final Action

The agency received no comments in response to the proposal.

Therefore, FDA concludes that, for the reasons set out in the proposal,

it is appropriate to amend Secs. 101.9(b)(5)(i) and 101.12(b) as

proposed to better reflect the amounts customarily consumed for these

products. Thus, in the final rule set forth below, FDA is revising its

food labeling regulations to: (1) Amend Sec. 101.12(b) by changing the

reference amount for ``Baking powder, baking soda, pectin'' from ``1

g'' to ``0.6 g'' (the weight of 1/8 tsp of baking powder and baking

soda, and close to the weight of 1/8 tsp of pectin); (2) amend

Sec. 101.9(b)(5)(i) by including 1/8 tsp as an additional allowable

household measure; and (3) reorganize Sec. 101.9(b)(5)(i) to simplify

the options for teaspoon and tablespoon measures and to improve

clarity.

III. Effective and Compliance Dates

Voluntary compliance with this final regulation, including any

required labeling changes, may begin April 15, 1999, and all affected

products initially introduced or initially delivered for introduction

into interstate commerce on or after January 1, 2002, shall fully

comply.

IV. Environmental Impact

The agency has previously considered the environmental effects of

this rule as announced in the proposed rule (62 FR 61476 at 61479). No

new information or comments have been received that would affect the

agency's previous determination that there is no significant impact on

the human environment and that an environmental impact statement is not

required.

V. Benefit--Cost Analysis

FDA has examined the economic implications of this final 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 regulatory

approaches that maximize net benefits (including potential

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economic, environmental, public health and safety, and other

advantages; (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, adversely affecting a sector of the economy in a

material way, or adversely affecting jobs or competition. A regulation

is also considered a significant regulatory action under Executive

Order 12866 if it raises novel legal or policy issues.

The Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4)

requires a cost-benefit analysis and other analyses when a rule is a

significant rule. Under section 1532(a) of the UMRA, a significant rule

is a rule containing ``any Federal mandate that may result in the

expenditure by State, local, and tribal governments, in the aggregate,

or by the private sector, of $100,000,000 or more (adjusted annually

for inflation) in any 1 year.''

Finally, the Small Business Regulatory Enforcement Fairness Act of

1996 (Pub. L. 104-121) defines a major rule for the purpose of

congressional review as having resulted in or being likely to result in

one or more of the following: An annual effect on the economy of $100

million or more; a major increase in costs or prices; significant

adverse effects on competition, employment, investment, productivity,

or innovation; or significant adverse effects on the ability of U.S.-

based enterprises to compete with foreign-based enterprises in domestic

or export markets.

FDA finds that this final rule is neither an economically

significant rule nor a significant regulatory action as defined by

Executive Order 12866. FDA has determined that this final rule does not

constitute a significant rule under the Unfunded Mandates Reform Act of

1995 (Pub. L. 104-4) and, therefore, this rule does not trigger the

requirement for a written statement under section 202(a) of the

Unfunded Mandates Reform Act. Furthermore, this rule is not a major

rule for the purpose of congressional review under the Small Business

Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121).

Because FDA received no comments on the proposal, the benefit-cost

analysis included in the proposed rule will not be changed.

This final 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.

VI. Small Entity Analysis

FDA has examined the economic implications of this final 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, FDA concludes that this

final rule will have a significant economic impact on a substantial

number of small entities.

FDA is amending the nutrition labeling regulations to change the

reference amount customarily consumed per eating occasion for baking

powder, baking soda, and pectin to more accurately reflect the amount

of these products customarily consumed. The agency is also adding 1/8

tsp as a household measure because it is a common household measure

available to consumers.

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 (SBA) 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 that might be relabeled as a result of this

rule.

B. Description of the Impacts

FDA received no comments on the preliminary regulatory flexibility

analysis and will, therefore, not alter that analysis. As estimated in

the analysis in the proposed rule, the cost of this rule per small firm

will be $1,200 ($600 x 2 products). The 95th percentile firm has annual

sales of $275,000 and 1 employee. The cost 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 which quartile this

firm belongs to 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 final 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 who are not exempt from compliance as

described in section VI.D.1 of this document will be required to amend

their labels to reflect the new serving sizes and to 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

In the proposed rule, FDA examined alternatives to the rule that

may minimize the significant economic impact on small entities

consistent with stated objectives. Both alternatives are described as

follows.

1. Exempt Small Entities

In Sec. 101.9(j)(18), the agency exempts from mandatory nutrition

labeling low volume food products of certain small businesses (see 61

FR 40963, August 7, 1996). Section 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 and

manufacturers have chosen to take advantage of the exemption, then

[[Page 12889]]

products might not require relabeling as a result of this rule.

However, if the products are currently nutritionally labeled 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 products, if any, can or will take advantage of this

option. FDA discussed this exemption in the proposed rule but no

comments were submitted.

2. Lengthen the Compliance Period

FDA also considered the option of providing small entities with a

longer compliance period. Longer compliance periods typically result in

lower costs because firms can combine mandated label changes with

planned changes and because firms have more opportunity to use up

existing labels. A compliance period longer than 1 year would reduce

costs to less than $1,200 per small firm. Because the mandatory

compliance date for this rule is January 1, 2002, firms will have

almost 3 years to come into compliance with this rule.

E. Description of Outreach to Small Entities

The Regulatory Flexibility Act requires a description of the

outreach activities undertaken by the agency to inform small entities

about the rule and to encourage comments from small businesses. In

addition to publishing the proposed rule in the Federal Register, the

agency also notified by phone all small businesses known to produce

products affected by the rule.

VII. The Paperwork Reduction Act of 1995

This final rule contains information collection requirements that

are subject to review by the Office of Management and Budget (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 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.

Title: Serving Sizes; Reference Amount for Baking Powder, Baking

Soda, Pectin.

Description: Section 403(q)(1)(A) and (q)(1)(B) of the Federal

Food, Drug, and Cosmetic 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 to 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 final rule revise the reference

amount that is used for determining the serving sizes for baking

powder, baking soda, and pectin. As a result, manufacturers and other

producers of these products are 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 regulations 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 Burden1

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Annual

21 CFR Section No. of Frequency per Hours per Total Hours Operating

Respondents Response Response 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 of information.

FDA believes that the burden associated with the disclosures

required by this final rule will be a one-time burden created by the

need for firms to change the statement of serving size and the number

of servings on the labels for their products. As noted above, 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 this final rule. Further, as noted above, FDA

estimates that the final rule will result in a one-time operating cost

of $39,600.

Individuals and organizations may submit comments on these burden

estimates or on any other aspect of these information collection

provisions, including suggestions for reducing the burden, and should

direct them to 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.

The information collection provisions in this final rule have been

approved under OMB control number 0910-0357. This approval expires on

January 31, 2001. An agency may not conduct or sponsor, and a person is

not required to respond to, a collection of information unless it

displays a currently valid OMB control number.

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, 21 CFR

part 101 is 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

[[Page 12890]]

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 ``Product category'' column, under ``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 Supply1, 2, 3, 4

------------------------------------------------------------------------

Product category Reference amount Label statement5

------------------------------------------------------------------------

* * * *

* * *

Miscellaneous Category:

Baking powder, baking soda, 0.6g __tsp (__g)

pectin

* * * *

* * *

------------------------------------------------------------------------

\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: March 9, 1999.

William K. Hubbard,

Acting Deputy Commissioner for Policy.

[FR Doc. 99-6299 Filed 3-15-99; 8:45 am]

BILLING CODE 4160-01-F