[Federal Register Volume 64, Number 50 (Tuesday, March 16, 1999)]
[Rules and Regulations]
[Pages 12887-12890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6299]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94P-0240]
Food Labeling; Serving Sizes; Reference Amount for Baking Powder,
Baking Soda, 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
[[Page 12888]]
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
