Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63647

iPub. L. 104–105 (February 10, 1996).

ii Generally, for each loan made by a qualified

lender, a borrower is subject to minimum stock

purchase requirements of 2 percent of the loan or

$1,000, whichever is less. The borrower rights

provisions of the Act impose certain disclosure and

other obligations on lenders.

iiiThe specific borrower rights under the Act that

are affected by the section 4.14A definitional

change include reconsideration of actions (sec.

4.14), restructuring distressed loans (sec. 4.14A),

effect of restructuring on borrower stock (sec.

4.14B), review of restructuring denials (sec. 4.14C),

protection of borrowers who meet all loan

obligations (sec. 4.14D), and right of first refusal

(sec. 4.36).

As enacted, the language of section 208 of the

1996 Act amending the definition of ‘‘loan’’ leaves

no doubt that Congress intended to include the

section 4.36 borrower’s right of first refusal among

the borrower rights that become inapplicable when

a loan is designated for sale into a secondary

market. This is consistent with section 8.9(a) of the

Act, which specifically exempts loans pooled under

title VIII from section 4.36 borrower rights.

However, section 208 of the 1996 Act did not

amend the introductory paragraph of section

4.14A(a), which limits the applicability of the

section’s definitions to those ‘‘used in this part [C

of title IV].’’ Since section 4.36 is located in part

G (‘‘Miscellaneous’’) of title IV, it could technically

be argued that the amended definition of ‘‘loan’’

does not apply to section 4.36. Notwithstanding this

apparent drafting inconsistency, the FCA believes

Congressional intent is clear and interprets the 1996

Act to exempt loans designated for sale into a

secondary market from the section 4.36 borrower’s

right of first refusal.

retired, but in no event may stock be

retired below the institution’s minimum

stock purchase requirements for the

interest retained.

(iv) If an institution repurchases a

loan on which the stock has been

retired, the borrower shall be required to

repurchase stock in the amount of the

minimum stock purchase requirement.

(2) Loans sold into a secondary

market. An institution’s bylaws may

provide that all outstanding voting stock

held by a borrower with respect to a

loan shall be retired when the loan is

sold into a secondary market.

(d) Applicability. In the case of a loan

sold into a secondary market under title

VIII of the Act, paragraphs (b)(1) and

(c)(2) of this section apply regardless of

whether the institution retains a

subordinated participation interest in a

loan or pool of loans or contributes to

a cash reserve.

§ 614.4336 Borrower rights in connection

with loan sales.

(a) Loan sales to Farm Credit System

institutions. Loans made by qualified

lenders (as defined in section

4.14A(a)(6) of the Act) and interests in

such loans that are sold to other

qualified lenders are subject to the

borrower rights provisions of title IV of

the Act.

(b) Loans designated for sale into a

secondary market. (1) Except as

provided in paragraph (b)(2) of this

section, the borrower rights provisions

of sections 4.14, 4.14A, 4.14B, 4.14C,

4.14D, and 4.36 of the Act do not apply

to a loan made on or after February 10,

1996, that is designated for sale into a

secondary market at the time it is made.

(2) If a loan designated for sale under

paragraph (b)(1) of this section is not

sold into a secondary market during the

180-day period that begins on the date

of designation, the borrower rights

provisions specified as inapplicable

pursuant to paragraph (b)(1) of this

section shall apply, provided that if the

loan is subsequently sold into a

secondary market, the borrower rights

specified in paragraph (b)(1) of this

section become inapplicable beginning

on the date of the subsequent sale.

(c) Other loan sales. (1) Except for

loans sold to another Farm Credit

institution or designated for sale into a

secondary market, a qualified lender

must comply with one of the following

two requirements before selling a loan

or interest in a loan that is subject to the

borrower rights provisions of title IV of

the Act:

(i) Include provisions in the contract

with the borrower, or a written

modification thereto, that ensure that

the purchaser of the loan will be

obligated to accord the borrower the

same rights qualified lenders must

provide under the Act; or

(ii) Obtain from the borrower a signed

written consent to the sale that

explicitly states that the borrower

relinquishes the statutory borrower

rights. The consent to the loan sale and

the relinquishment of the borrower

rights shall have no effect until the loan

is actually sold and shall be ineffective

in the event that the lender or any other

Farm Credit System institution

repurchases the loan or any interest

therein.

(2) Before obtaining the borrower’s

consent to the sale of the loan and the

relinquishment of borrower rights

pursuant to paragraph (c)(1)(ii) of this

section, the lending institution shall

disclose in writing to the borrower:

(i) A full and complete description of

the statutory rights that the borrower is

asked to relinquish;

(ii) Any changes in the loan terms or

conditions that will occur if the loan is

not sold; and

(iii) The fact that the relinquishment

of the statutory borrower rights will not

become effective unless the loan is

actually sold and shall become

ineffective in the event that the lender

or any other Farm Credit System

institution repurchases the loan or any

interest therein.

(3) The making of a loan may not be

conditioned on the borrower’s consent

to its sale and relinquishment of

statutory borrower rights.

Subpart K—Disclosure of Loan

Information

§ 614.4367 [Amended]

3. Section 614.4367 is amended by

removing paragraph (b) and

redesignating paragraphs (c) through (e)

as paragraphs (b) through (d).

Dated: November 24, 1997.

Nan P. Mitchem,

Acting Secretary, Farm Credit Administration

Board.

[FR Doc. 97–31569 Filed 12–1–97; 8:45 am]

BILLING CODE 6705–01–P

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.

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.
63648 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

1The 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.

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 § 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 weightbased 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 primafacie 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 volumebased 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

consumption2 (Ref. 1).

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 shortterm (3 weeks) nature of the consumer
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 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 lowdensity 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 lowdensity 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 lowdensity 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 reducedsodium 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 weightbased 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 volumebased 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
63650 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

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 lowdensity 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 lowdensity salt is 33 percent lower in

density than regular salt, FDA

calculated that consumption of the lowdensity 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 lowdensity 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 § 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
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 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 § 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 lowdensity 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 volumebased 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 (§ 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 § 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
63652 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

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 § 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 § 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

§ 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

21 CFR Section No. of

Respondents

Total No. of ResponsesHours per

Response Total Hours Total OperatingCosts

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.
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 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:

§ 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 (ll g); ll piece(s) (ll

g) for discrete pieces (e.g.,

individually packaged products).

* * * * * * *

1These 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. 5The 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 § 101.9(b) using the reference amount determined according to § 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 97P–0206]

Food Labeling: Health Claims; Dietary

Sugar Alcohols and Dental Caries

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

decision to amend the regulation that

authorizes a health claim on sugar

alcohols and dental caries to include the

sugar alcohol erythritol among the

substances that may be the subject of the

claim. Based on its review of evidence

submitted with a comment on the

proposal, and the evidence described in

the proposal, the agency has concluded

that there is significant scientific

agreement that erythritol does not

promote dental caries. Therefore, FDA

has decided to amend the sugar alcohol

and dental caries health claim to

include erythritol. FDA is announcing

this action in response to a petition filed

by the Cerestar Holding B.V., Mitsubishi

Chemical Corp., and Nikken Chemicals

Co. (the petitioners).

EFFECTIVE DATE: December 2, 1997.

FOR FURTHER INFORMATION CONTACT:

Joyce J. Saltsman, Center for Food Safety

and Applied Nutrition (HFS–165), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5483.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 9, 1997

(62 FR 36749), the agency proposed to

amend the regulation that authorizes a

health claim on sugar alcohols and

dental caries (§ 101.80 (21 CFR 101.80))

to include the sugar alcohol erythritol

among the substances that may be the

subject of the claim. FDA issued the

proposed rule in response to a petition

filed under section 403(r)(3)(B)(i) and

(r)(4) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

343(r)(3)(B)(i) and (r)(4))). Section

403(r)(3)(B)(i) of the act states that the

Secretary of Health and Human Services

(and, by delegation, FDA) shall issue

regulations authorizing health claims

only if he or she determines, based on

the totality of publicly available

scientific evidence (including evidence