Food Labeling; Serving Sizes; Reference Amount for Salt, Salt Substitutes, Seasoning Salts (e.g., Garlic Salt)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 93P-0448]

Food Labeling; Serving Sizes; Reference Amount for Salt, Salt

Substitutes, Seasoning Salts (e.g., Garlic Salt)

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 ``Salt,

salt substitutes, seasoning salts (e.g., garlic salt)'' from a weight-

based reference amount of 1 gram (g) to a volume-based reference amount

of 1/4 teaspoon (tsp). This action is necessary to provide consistency

with the agency's criteria for determining volume-based versus weight-

based reference amounts for all product categories.

DATES: Effective January 1, 2000. This regulation applies to all

affected products initially introduced or initially delivered for

introduction into interstate commerce on or after this date. Voluntary

compliance may begin January 2, 1998. Written comments on the

information collection provisions should be submitted by January 2,

1998.

ADDRESSES: Submit written comments on the information collection

provisions to the Office of Information and Regulatory Affairs, Office

of Management and Budget (OMB), New Executive Office Bldg., 725 17th

St.

[[Page 63648]]

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

A. The Nutrition Labeling and Education Act of 1990

On November 8, 1990, Congress passed the Nutrition Labeling and

Education Act (the 1990 amendments). This statute amended the Federal

Food, Drug, and Cosmetic Act (the act) in section 403(q)(1)(A)(i) to

require that virtually all foods bear nutrition information that is

based on a serving size that reflects the amount of food that is

customarily consumed and that is expressed in a common household

measure appropriate to the food (21 U.S.C. 343(q)(1)(A)(i), added to

the act by section 2(a) of the 1990 amendments). The new law also

directed FDA to adopt regulations that establish standards to define

serving sizes (section 2(b)(1)(B) of the 1990 amendments).

After extensive notice-and-comment rulemaking, the agency published

final rules implementing the 1990 amendments. In part, these rules

established ``reference amounts customarily consumed per eating

occasion'' (reference amounts) for use by industry as the basis for

serving sizes for most foods. With regard to salt products, the agency

concluded that 1 g was the appropriate reference amount for ``Salt,

salt substitutes, seasoning salts (e.g., garlic salt)'' (58 FR 2229 at

2297, January 6, 1993).

In addition, in discussing a different food category, FDA outlined

the circumstances in which a weight-based reference amount would not

adequately reflect the amount of food customarily consumed per eating

occasion (Comment 20, 58 FR 2229 at 2238). The agency stated that

weight-based reference amounts are not appropriate when foods within a

product category vary considerably in density, i.e., there is a density

difference of 25 percent or more among the products in the category

(see Sec. 101.12(e) (21 CFR 101.12(e))), and when the customarily

consumed amounts for different products are more uniform when expressed

in volume than in weight.

B. Petition to Modify the Reference Amount for Salt Products

In November of 1993, FDA received a petition requesting that it

change the reference amount for salt from a weight-based reference

amount of ``1 g'' to a density-adjusted reference amount to be listed

as ``x g - 1/4 tsp.'' The petition included the results of a consumer

study of consumption patterns of regular salt and low-density salt and

analytical data comparing the physical properties (including density)

of regular salt and low-density salt.

In response to a request from the agency, the petitioner submitted

supplemental materials consisting of information regarding the

protocol, data tabulation, and results of the consumer study it had

submitted, including an independent evaluation of the results and

conclusions.

FDA received one comment requesting that the agency reject the

petition. The comment argued against granting the petition, questioned

the consumer study data, and disagreed with the results and conclusions

contained in the petition. The agency received comments from the

petitioner that responded to the arguments presented in this comment.

After reviewing the information in the petition, the supplemental

submission, and the comments, FDA determined that the petitioner had

made a prima-facie case that a volume-based reference amount of 1/4 tsp

for salt is more appropriate than the weight-based reference amount of

1 g that FDA adopted in 1993. Therefore, in accordance with 21 CFR

10.30(e)(2)(i), in the Federal Register of July 21, 1995 (60 FR 37616),

FDA issued a proposed rule (hereinafter referred to as ``the proposed

rule on salt products'') to change the reference amount for ``Salt,

salt substitutes, seasoning salts (e.g., garlic salt)'' from a weight-

based reference amount of ``1 g'' to a volume-based reference amount of

``1/4 tsp.'' The agency requested comments on whether low-density salt

products should be required to disclose clearly that they contain more

air than conventional or regular salt products, and, if so, on what

kind of descriptive terms would convey this information in a manner

that is clear and nonmisleading for consumers.

This final rule responds to the comments FDA received in response

to the proposed rule on salt products.

II. Review of Comments

FDA received and reviewed four responses to the proposed rule on

salt products, each of which contained one or more comments. Two

responses were received before and two after the close of the comment

period. The two late comments discussed data and reiterated arguments

contained in other comments.

A. Consumer Study of Consumption Patterns of Regular Versus Low-Density

Salt

1. One comment noted that the original questionnaires from the

consumer study submitted by the petitioner were no longer available, so

an independent assessment of the data is no longer possible. The

comment objected to using results and relying on conclusions that were

based on summaries of the questionnaires.

Before acting on the petition, FDA specifically requested and

received additional study data and summary tables that were not

contained in the original petition (Docket 93P-0448/REF 1) \1\. The

agency reviewed the study data and assessed the quality of the study

design and the independent verification process. The agency tentatively

concluded that the consumer research was a reasonably well-controlled

experiment that met the scientific standards for the type of studies

that can be used to determine household salt consumption\2\ (Ref. 1).

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\1\ The agency filed these materials in Docket 93P-0448, where

they are identified as ``REF 1.'' As discussed further in section

II.D. of this document, Exhibit E was removed from the original

submission.

\2\ In this document, the agency is citing relevant material to

Serving Sizes; Reference Amount for Salt and Salt Substitutes,

Seasoning Salts (e.g., Garlic Salt) that originally appeared in Ref.

2 of the proposed rule on salt products that appeared in the Federal

Register of July 21, 1995 (60 FR 37616 at 37620). (See Docket No.

93P-0448.) For the convenience of the reader the materials are

contained in ``Ref. 1'' of this document.

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The study was conducted in 1982 by an independent company (Ref. 1).

Furthermore, the study results were authenticated by a separate

marketing consulting firm and by an independent consultant. Section

101.12(h) does not require submission of raw data questionnaires for

serving size petitions. The agency is satisfied with these salt

consumption data and results because the data were independently

gathered and compiled, and the study results were independently

verified. The comment presented no basis for questioning the work done

on the study.

The agency concludes that the absence of the original

questionnaires is not significant, and that it is appropriate to rely

on the results of the consumer study to represent consumption of

regular and low-density salts.

2. One comment objected to the short-term (3 weeks) nature of the

consumer

[[Page 63649]]

study, suggesting that it is likely that some consumers newly exposed

to a low-density salt product would initially use less (by habit) and,

eventually, could adjust the amount used to attain the desired salt

flavor. The comment suggested that the adjustment period may not occur

quickly and could be sufficient to distort the results of a 3-week

study.

In an agency review of the petition, FDA considered concerns about

the length of the study (a 6-week study period consisting of two

consecutive 3-week periods, with each household receiving low-density

salt during one of the two 3-week periods) (Ref. 1). FDA considered the

possibility that a 3-week period might not be sufficient to estimate

long term change in salt consumption when using a low-density salt

product, and that salt consumption might change over a longer time

period.

The agency noted in the review that the test product ratings

revealed that the participants in the study did not report a sense of

deprivation when using the low-density salt that would cause them to

increase the volume of salt they consumed (Ref. 1). Consumption of both

regular and low-density salts increased substantially over the course

of the study (Ref. 1). The increases in consumption of the two types of

salt were not significantly different.

The comment did not take issue with any of these findings of the

study. The comment merely made general allegations about the length of

the study and its ability to make valid findings.

FDA finds no merit to these general allegations given the findings

of the study. Both the absence of a sense of deprivation in those using

the low-density salt and the fact that the increase in consumption of

low-density salt was consistent with the increase in consumption of

regular salt suggest that the level of consumption of this product is

likely to persist. Therefore, FDA can find nothing in this study to

support the view that its results were not representative of long-term

use of low-density salt.

3. One comment stated that the petitioner sponsored two studies and

combined the data to determine the amount of low-density salt used. The

comment asserted that, by combining the data from two studies, the

consumption figures for each individual study have been irretrievably

blended, and the amounts of low-density salt used in each of the two

separate studies are not available. The comment stated that FDA should

be concerned about this unconventional handling of data because

reporting combined data suggests that direct consumption comparisons

did not support the conclusions desired by the study's sponsor.

FDA does not agree that the petitioner submitted data from two

studies, or that the data from separate studies were incorrectly

combined. The agency notes that in 1982, the petitioner conducted one

study of 320 households of salt users, using a multi-level design. The

comment misinterpreted the two levels of the research design to be two

separate studies. On one level of the design, data from 208 households

in the sample were used to compare consumption of low-density salt that

was labeled as regular salt to consumption of regular salt labeled as

such. On another level, data from 112 of the households in the sample

were used to compare consumption of low-density salt that was labeled

as reduced-sodium salt to consumption of low-density salt that was

labeled as regular salt. Thus, the study provided data describing

consumption of three forms of salt: (1) Low-density salt labeled as

reduced-sodium salt; (2) low-density salt labeled as regular salt; and

(3) regular salt labeled as such.

Based on the study results, FDA has determined that the available

data and information are adequate to verify that all data that describe

consumption of low-density salt are similar and are considerably lower

on a weight basis than those that describe consumption of regular salt.

The data show that, for 320 households, the average amounts consumed

per household over the 3-week period of the survey were as follows: (1)

170.51 g for low-density salt labeled as reduced-sodium salt; (2) 168.8

g for low-density salt labeled as regular salt; and (3) 285.75 g for

regular salt labeled as such. The petitioner stated, and FDA verified,

that participants used significantly less (41 percent) low-density salt

than regular salt.

Thus, FDA concludes that there was a single study that provided

adequate data to determine comparative consumption of low-density salt

and regular salt, and that the procedures used in analysis of the data

were valid.

B. Weight-Based Versus Volume-Based Reference Amount for Salt, Salt

Substitutes, Seasoning Salts (e.g., Garlic Salt)

4. One comment objected to using the findings of the consumer study

as the basis for changing from a weight-based to a volume-based

reference amount. The comment stated that conclusions drawn from the

data submitted in the petition do not demonstrate that salt consumption

is more uniform when expressed in terms of volume than in terms of

weight. The comment also objected to FDA's policy of establishing

volume-based reference amounts whenever a 25-percent density variance

is established by the manufacturer of a single product. The comment

contended that this policy is an invitation to any food manufacturer to

extend a product with 25 percent or more air and thereby to become

eligible for special regulatory treatment.

Another comment supported a volume-based reference amount for salt,

noting that some seasoning salts that are lighter in density than

regular salt must declare the serving size as ``1/2 tsp.'' The comment

stated that the proposed change to ``1/4 tsp'' would ``make seasoning

salt usage more consistent overall regardless of the density of the

salt or salt blend,'' would standardize information for spices and

seasonings, and would be consistent with the current reference amount

for spices and herbs (which is 1/4 tsp or 0.5 g if not measurable by

tsp). The comment did not provide data to support the density

differences among various seasoning salts.

The 1990 amendments require that nutrition information be based on

a serving size that reflects the amount of food customarily consumed,

expressed in a common household measure appropriate to the food. As

stated in the final rule on serving sizes (Comment 20, 58 FR 2229 at

2238), FDA used weight-based reference amounts except in those

instances in which it was demonstrably inappropriate to do so. The

agency outlined the circumstances in which a weight-based reference

amount would not adequately reflect the amount of food customarily

consumed per eating occasion. FDA provided for volume-based reference

amounts in cases in which: (1) The product can easily be measured by

volume; (2) the density of foods within the product category varies

widely; and (3) the amount customarily consumed is more uniform when

expressed as a volume than as a weight. For products meeting these

criteria, volume-based reference amounts ensure that serving sizes will

more accurately reflect the amounts customarily consumed in accordance

with the requirements of the statute.

FDA has applied this approach to all products that meet the three

criteria listed previously (e.g., to mixed dishes measurable with a cup

(Comment 20, 58 FR 2229 at 2238), to peanut butter (Comment 108, 58 FR

2229 at 2263), and to waffles (Comment 138, 58 FR 2229 at 2263)). This

policy provides for serving sizes that accurately reflect consumption,

the regulatory standard. It

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does not represent special regulatory treatment of aerated food

products as one comment asserted.

As stated in the proposed rule on salt products (60 FR 37616 at

37618) and acknowledged in the comments, salt products can be measured

by volume. Furthermore, the density difference between regular salt and

low-density salt is significant (33 percent) and demonstrates that the

densities of products within the category vary widely.

In determining whether people consume similar volumes, rather than

similar weights, of regular and low-density salt, FDA first considered

the consumer study data submitted. FDA reviewed the mean and standard

error for the consumption of regular salt labeled as such, low-density

salt labeled as regular salt, and low-density salt labeled as reduced-

sodium salt (Ref. 1). The agency noted that, on a per household basis,

consumption of the low-density salt product was 41 percent lower by

weight than consumption of the regular salt product. Because low-

density salt is 33 percent lower in density than regular salt, FDA

calculated that consumption of the low-density salt product was 11

percent lower by volume than consumption of the regular salt product

(Ref. 2). Thus, because the percent discrepancy is less on a volume

basis than on a weight basis (11 percent versus 41 percent), the study

data support that salt consumption is more consistent when expressed on

a volume rather than on a weight basis.

Based on the standard that FDA established in 1993 on whether to

use a weight-based or a volume-based reference amount and on the

consumer study data that were not available to the agency in 1993, FDA

concludes that a volume-based reference amount is appropriate for salt,

salt substitutes, and seasoning salts because, in addition to the fact

that salt products can be measured by volume and vary widely in

density, such a reference amount more accurately reflects consumption

of salt and salt products and provides greater consistency in the

labeling of all salts, salt substitutes, seasoning salts, spices, and

herbs.

5. One comment stated that, although most recipes and cookbooks

list specific volume measurements for salt, other recipes and cooking

instructions state that the user should ``salt to taste'' or ``correct

the seasoning.'' The comment included several articles and studies

supporting FDA's initial position that a weight-based reference amount

is appropriate because many consumers salt ``to taste.'' These studies

indicated that: (1) Many shoppers (56 percent) modify recipes, and more

than half cook without recipes at times; (2) table salt practices vary

with some people adding salt before tasting (by habit) and some adding

salt after tasting (to taste); (3) when people were restricted from

using table salt, some compensated by increasing the salt added during

cooking; and (4) when individuals were provided meals containing little

or no salt, the table salt usage increased.

The comment also objected to statements made by the petitioner

comparing solubility and taste of regular salt and low-density salt.

The comment noted that the petitioner submitted no sensory data with

the petition. The comment included study data from a taste panel that

showed that four out of five respondents reported that biscuits and

scrambled eggs made with regular salt tasted saltier than biscuits and

scrambled eggs made with the same volume of low-density salt.

The comment concluded that nothing was presented in the petition to

alter the logic of FDA's initial determination that people use

ingredients such as salt or sugar ``to attain the level of sweetness or

saltiness they desire'' (58 FR 2229 at 2260). The comment concluded

that the reference amount for salt products should be based on weight

to maintain the same level of saltiness.

FDA has reviewed the studies, articles, and cookbook information

cited in the comments. It appears that there is considerable

variability in how consumers use salt. The information supports that

some consumers do salt or cook ``to taste'' (Refs. 3 through 5). People

who salt to taste (e.g., tasting soup during preparation) are likely to

use similar weights of low-density salt and regular salt. A weight-

based reference amount would accurately reflect this type of use.

However, the same information supports that other consumers salt

``by habit'' (e.g., two shakes of a salt shaker) or cook according to

recipe directions (e.g., by volume as specified in a recipe) (Refs. 3

through 5). These people would be likely to use similar volumes of low-

density salt and regular salt because measurements of salt in recipes

are specified by volume, and because the amount of salt delivered by

salt shakers (i.e., the number of granules) is strongly influenced by

the hole size of the salt shaker (Ref. 5). A volume-based reference

amount would accurately reflect these types of uses.

FDA also reviewed the taste panel study data that were submitted in

the comment comparing the taste of biscuits and eggs made with regular

salt to that of biscuits and eggs made with the same volume of low-

density salt. These data were ambiguous. Findings, which were included

in the comment, showed that while some participants rated the biscuits

and eggs made with regular salt as more salty, many reported no

difference in taste, and some rated the products made with low-density

salt as having a more desired, ``moderate'' salty taste.

Based on the studies and articles cited previously, when consumers

at home use recipes similar to those used for the test panel, it is

likely that some people will alter the recipes to produce the level of

``saltiness'' desired, which would support a weight-based reference

amount. However, others will be likely to prepare the recipes as

directed and thus will consume the same number of biscuits regardless

of which salt is used in their preparation, which would support a

volume-based reference amount.

FDA considered sensory (e.g., taste) issues in terms of their

impact on consumption, the statutory standard. FDA agrees that sensory

attributes (e.g., taste) may affect the amounts of regular and low-

density salt used. However, the articles and studies submitted with the

comments and the study data from the taste panel are ambiguous and can

be interpreted to support salt use either by weight or by volume. Thus,

FDA concludes that the sensory data are inconclusive in demonstrating

whether similar weights or similar volumes of regular and low-density

salt are customarily consumed.

C. Descriptive Labeling to Differentiate Salt and Low-Density Salt

In the proposed rule on salt products (60 FR 37616 at 37619), FDA

requested comments on whether low-density salt products should be

required to clearly disclose that they contain more air than

conventional salt products. The agency noted that Sec. 101.12(e), which

applies to discrete products like waffles, requires that the aerated

version bear a descriptive term indicating that air has been

incorporated (e.g., whipped, aerated). FDA stated that some product

categories that have volumetric reference amounts contain products with

common or usual names that clearly indicate that air has been

incorporated into the product (e.g., whipped peanut butter, whipped

dessert topping). Some products in other product categories with

volumetric reference amounts do not bear such descriptive terms (e.g.,

pudding, ice cream).

The agency stated that because regular salt and low-density salt

have similar appearances, terms such as ``whipped

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salt'' or ``aerated salt'' could be confusing to consumers. Therefore,

FDA requested comments on what kind of descriptive terms would be clear

and nonmisleading for consumers.

6. One comment stated that some kind of differential labeling

(e.g., ``aerated salt'' or ``fluffed salt'') should be required to

prevent misbranding and to allow consumers to make an informed

purchasing decision.

FDA agrees that descriptive labeling is needed on low-density salt

to ensure that consumers understand how this product differs from

regular crystalline salt and are fully informed about important product

characteristics. Section 101.3 (21 CFR 101.3) establishes requirements

for the statement of identity of a food. Section 101.3(c) requires that

when a food is marketed in various optional forms, the particular form

shall be considered to be a necessary part of the statement of

identity. Terms such as ``low-density salt'' or ``flaked salt

crystals'' would meet these requirements because they describe the

characteristic that distinguishes low-density salt from regular

crystalline salt. This information must appear as part of the statement

of identity on the principal display panel under Sec. 101.3.

As stated in the second paragraph of section II.C of this document,

FDA expressed concern in its proposed rule on salt products, that,

because low-density salt looks similar to regular salt, some terms

(e.g., ``aerated'' or ``whipped'') might be confusing to consumers.

However, if manufacturers conduct consumer studies that demonstrate

that terms such as ``aerated,'' ``fluffed,'' or ``whipped'' are

understood by consumers as distinguishing low-density salt from regular

salt, these additional terms or descriptions could also be used. FDA

concludes that the statement of identity for a low-density salt product

must not be false or misleading and must include a description of the

form of the salt. If a product does not bear such a statement of

identity, it would be subject to regulatory action under section

403(i)(1) of the act.

D. Marketing Strategy Information

7. One comment stated that some of the relevant data were not

included as part of the public record. The comment noted that a volume-

based reference amount accommodates a misleading marketing strategy for

low-density salt. Consequently, the comment contended that the

materials contained in Exhibit E of the supplemental

materials1, which were identified as pertaining to marketing

strategies and which were removed from the supplemental materials

before filing the materials in the docket, need to be made publicly

available to ensure informed comment before any final action is taken.

All relevant data and information were included as part of the

public record. The agency does not agree that materials pertaining to

marketing strategies (Exhibit E in the supplemental materials) needed

to be made publicly available to ensure informed comment. The material

contained in Exhibit E does not contain any information relevant to a

decision on the determination of a reference amount and serving size

for salt products, and the agency did not use any of the material

contained in Exhibit E during its deliberations. Marketing strategies

fall within the definition of confidential commercial information

(e.g., valuable data or information which is used in one's business and

is of a type customarily held in strict confidence or regarded as

privileged). Thus, these materials are not available for public

disclosure under 21 CFR 20.61.

III. The Final Regulation

FDA determined in 1993 that volume-based reference amounts are

appropriate when: (1) Products are bulk products that can be measured

by volume (final rule for serving sizes, comment 20, 58 FR 2229 at

2238; and comment 108, 58 FR 2229 at 2263); (2) there are significant

differences in densities among the products within a product category,

such that a range of densities are represented within the product

category (see discussions on aerated products (Sec. 101.12(e)) and

peanut butter (final rule for serving sizes, 58 FR 2229 at 2263)); and

(3) the amount customarily consumed is more uniform when expressed in

terms of volume; that is, there is some indication or likelihood that

similar volumes, rather than similar weights, of both low- and high-

density products within the same product category are customarily

consumed (proposed and final rules for serving sizes, 56 FR 60394 at

60406, November 27, 1991; and 58 FR 2229 at 2238).

Although the sensory data, discussed in section II.B of this

document, indicate that there is variability in how salt products are

used, the evidence from the consumer study of consumption patterns for

regular and low-density salt, outlined and discussed in sections II.A

and B of this document, supports that people consume more similar

volumes than weights of salt products. Because of this fact and the

facts that the products within the category can be measured

volumetrically, and the density differences among products within the

same product category are significant, FDA concludes that it is

appropriate for the reference amount for salt and salt products to be

expressed as a volume rather than as a weight. Therefore, the agency is

changing the reference amount for salt and salt products in

Sec. 101.12(b), Table 2, from ``1 g'' to ``1/4 tsp.''

IV. Effective Date

Compliance with this final regulation, including any required

labeling changes, may begin January 2, 1998, and all affected products

initially introduced or initially delivered for introduction into

interstate commerce on or after January 1, 2000, shall fully comply.

V. Environmental Impact

The agency has previously considered the environmental effects of

this rule as announced in the proposed rule on salt products (60 FR

37616 at 37619). 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.

VI. Analysis under Executive Order 12866

FDA has examined the economic implications of the 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 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 final rule is not a significant rule as defined by

Executive Order 12866.

FDA received one comment which objected to the agency's tentative

finding that there is no cost to industry. The comment explained that

some labels would need to be modified and requested a 1 year phase in

period to allow industry to exhaust current label inventories.

FDA agrees that some labels will need to be modified at a small

cost to industry--approximately $600 per label on average. Based on

information submitted by the comment, there are

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167 labels that will need to be relabeled as a result of this rule

(Ref. 6). Although FDA recognizes that there may be more items

requiring relabeling than those with which the agency is familiar, the

number is not likely to be large. If there are approximately 200 labels

affected by this rule, then the costs will be $120,000.

In the section IV of this document, FDA stated that this final rule

has a compliance date in accordance with the uniform compliance date

for food labeling requirements which is not sooner than 1 year

following publication of this rule.

VII. Small Entity Analysis

FDA has examined the economic implications of the 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.

FDA is not aware that any of the items that will require relabeling

are produced by small entities, defined as fewer than 500 employees.

Therefore, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the

agency certifies that this final rule will not have a significant

impact on a substantial number of small entities.

VIII. The Paperwork Reduction Act of 1995

This final rule contains information collection requirements that

are subject 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, when appropriate, and other forms of

information technology.

Title: Serving Sizes; Reference Amount for Salt, Salt Substitutes,

Seasoning Salts (e.g., Garlic Salt).

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

that the label or labeling of a food bear information that provides the

serving size that is appropriate to the food and the number of servings

per container. FDA has issued regulations in Sec. 101.9(d)(3) (21 CFR

101.9(d)(3)) that require the nutrition facts panel on the label of a

food product disclose information on serving size and on servings per

container. FDA has also issued regulations in Sec. 101.9(b) that

provide that the serving size shall be determined based upon the

``Reference Amounts Customarily Consumed Per Eating Occasion'' that are

prescribed in Sec. 101.12(b).

This final rule revises the value for the reference amount

customarily consumed per eating occasion for the food category ``Salt,

salt substitutes, seasoning salts (e.g., garlic).'' This value is used

by food producers to determine the serving sizes and number of servings

to be listed on packages of salt, salt substitutes, and seasoning salts

(e.g., garlic). As a result, manufacturers and other producers of

certain of these products will be required to change the serving sizes

and number of servings per container that they disclose in the

nutrition facts panel for their products.

Description of Respondents: Persons and businesses, including small

businesses.

Table 1.--Estimated Annual Reporting and Recordkeeping Burden

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

No. of Total No. of Hours per Total Operating

21 CFR Section Respondents Responses Response Total Hours Costs

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

101.12(b) 5 200 1 200 $120,000

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

There are no capital or maintenance costs associated with this collection of information.

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 final 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. Because firms already list the

serving size for salt, salt substitutes, and seasoning salts (e.g.,

garlic) in terms of ``1/4 teaspoons,'' FDA believes that the only firms

that will have to revise their labels as a result of the regulation

codified in this document are those that market low-density salt

products. As noted in Table 1 of this document, FDA estimates that

there are less than five firms producing salt, salt substitutes, and

seasoning salts (e.g., garlic) that will need to change the labels for

their products. 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 in Table 1 of this document, the final rule

would result in a one-time operating cost of $120,000.

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 this final rule to OMB for review.

Interested persons are requested to send comments regarding information

collection by January 2, 1998, to the Office of Information and

Regulatory Affairs, OMB (address above), ATTN: Desk Officer for FDA.

IX. References

The following references have been placed on display in the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by

interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Memorandum from Brenda M. Derby, CFSAN, FDA, to Ellen M.

Anderson, CFSAN, FDA, June 20, 1994.

2. Bender, Mary M., and Ellen M. Anderson, memorandum to file,

August 28, 1997.

3. Mittelmark, Maurice B., and Barbara Sternberg, ``Assessment

of Salt Used at the Table: Comparison of Observed and Reported

Behavior,'' American Journal of Public Health, 75:1215-1216, 1985.

[[Page 63653]]

4. Gilbert, Linda, contributing ed., ``Leisure Cooking Still

Popular,'' Food R & D, February 1985.

5. Greenfield, H., J. Maples, and R. B. H. Wills, ``Salting of

Food--A Function of Hole Size and Location of Shakers,'' Nature,

301:331, 1983.

6. Letter from Marlene L. McKone, McCormick & Company, Inc., to

Ellen M. Anderson, CFSAN, FDA, September 26, 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, 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 101.12 is amended in paragraph (b), in Table 2, under

the ``Product category'' column, under the ``Miscellaneous Category''

by revising the entry for ``Salt, salt substitutes, seasoning salts

(e.g., garlic salt)'' 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:

* * * * * *

*

Salt, salt substitutes, seasoning

salts (e.g., garlic salt).......... 1/4 tsp 1/4 tsp (____ g); ____ piece(s)

(____ g) for discrete pieces (e.g.,

individually packaged products)

* * * * * *

*

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

\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: November 20, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-31462 Filed 12-1-97; 8:45 am]

BILLING CODE 4160-01-F