[Federal Register Volume 62, Number 231 (Tuesday, December 2, 1997)]
[Rules and Regulations]
[Pages 63647-63653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31462]


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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

[[Page 63650]]

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

[[Page 63651]]

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

[[Page 63652]]

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