[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