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
63654 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

from well-designed studies conducted

in a manner which is consistent with

generally recognized scientific

procedures and principles), that there is

significant scientific agreement, among

experts qualified by scientific training

and experience to evaluate such claims,

that the claim is supported by such

evidence (see also § 101.14(c) (21 CFR

101.14(c))). Section 403(r)(4) of the act

sets out the procedures that FDA is to

follow in health claim rulemakings.

Section 101.80(c)(2)(ii) sets out the

circumstances in which a sugar alcohol

is eligible to be the subject of a health

claim. Section 101.80(c)(2)(ii)(A) states

that the food must meet the requirement

for a sugar free food set out in 21 CFR

101.60(c)(1)(i). Section

101.80(c)(2)(ii)(B) lists the sugar

alcohols that are eligible to bear the

claim, xylitol, sorbitol, mannitol,

maltitol, isomalt, lactitol, hydrogenated

starch hydrolysates, hydrogenated

glucose syrups, or a combination of

these. Section 101.80(c)(2)(ii)(C) states

that:

When fermentable carbohydrates are

present in the sugar alcohol-containing food,

the food shall not lower plaque pH below 5.7

by bacterial fermentation either during

consumption or up to 30 minutes after

consumption as measured by the indwelling

plaque pH test found in ‘‘Identification of

Low Caries Risk Dietary Components,’’ * * *

which is incorporated by reference * * * .

At the time that it adopted § 101.80,

the agency stated that for other sugar

alcohols to be included in

§ 101.80(c)(2)(ii)(B), a petitioner must

show how the substance conforms to the

requirements of §§ 101.14(b) and 101.80

(61 FR 43433 at 43442, August 23,

1996). FDA stated ‘‘For those substances

that are to be consumed at other than

decreased dietary levels, the petitioner

must demonstrate to FDA’s satisfaction

that the substance is safe and lawful

under the applicable food safety

provisions of the act (§ 101.14(b)(3)(ii)).’’

Likewise, the petitioner would need to

provide evidence that the sugar alcohol

will not lower plaque pH below 5.7.

Therefore, before a claim can be made

for a new sugar alcohol, it must be

shown to meet the requirements for

§ 101.80. When this is demonstrated,

FDA will take action to add the

substance to the list in this regulation,

which has been renumbered as

§ 101.80(c)(2)(ii)(B) (61 FR 43433 at

43442).

FDA considered the relevant scientific

studies and data presented in the

petition as part of its review of the

scientific literature on erythritol and

dental caries. The agency summarized

this evidence in the proposed rule (62

FR 36749).

Based on the available evidence, FDA

tentatively concluded that the use of

erythritol in food is safe and lawful, and

that this substance meets the plaque pH

and other requirements of § 101.80.

Consequently, FDA proposed to amend

§ 101.80(c)(2)(ii)(B) to include erythritol

as one of the sugar alcohols that is

eligible to bear the sugar alcohol and

dental caries health claim. FDA did not

propose to make any other changes to

§ 101.80.

In response to the proposal, the

agency received one comment from a

manufacturer. The comment supported

the proposed amendment to § 101.80 to

include erythritol.

Given the absence of any evidence to

the contrary, FDA is confirming the

tentative conclusions that it reached in

the proposal. Based on these

conclusions, FDA is amending § 101.80

to add erythritol to the substances listed

in § 101.80(c)(2)(ii)(B) that may be the

subject of the claim.

II. Environmental Impact

The agency has previously considered

the environmental effects of this rule as

announced in the proposed rule (62 FR

36749). The proposed rule incorrectly

cited a claim of categorical exclusion

under previous 21 CFR 25.24(a)(11). The

agency reviewed the information

submitted by the petitioner in an

environmental assessment prepared

under 21 CFR 25.31a(b)(5). Based on

this information, the agency determined

that there is no significant impact on the

human environment and that an

environmental impact statement is not

required. No new information or

comments have been received that

would affect the agency’s previous

determination. The agency’s finding of

no significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

III. Executive Order 12866 Analysis

FDA has examined the impacts of the

final rule under 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 that 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 rule is not a

significant rule as defined by Executive

Order 12866.

The authorization of health claims

about the relationship between

erythritol and dental caries results in

either costs or benefits only to the extent

that food manufacturers elect to take

advantage of the opportunity to use the

claim. This rule will not require that

any labels be redesigned, or that any

product be reformulated.

This final health claim will allow

manufacturers to highlight the benefits

of the sugar alcohol erythritol in

addition to other sugar alcohols for

which FDA has already approved a

health claim. The benefit of establishing

this health claim is to provide for new

information in the market regarding the

relationship of erythritol and dental

caries and to provide consumers with

the assurance that this information is

truthful, not misleading, and

scientifically valid.

IV. Small Entity Analysis

FDA has examined the impacts of the

final rule under 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 regulatory options

that would minimize the economic

impact of that rule on small entities.

Small entities will incur costs only if

they opt to take advantage of the

marketing opportunity presented by this

regulation. FDA cannot predict the

number of small entities that will

choose to use the claim. However, no

firm, including small entities, will

choose to bear the cost of redesigning

labels unless they believe that the claim

will result in increased sales of their

product. Therefore, this rule will not

result in either a decrease in revenues

or a significant increase in costs to any

small entity. Accordingly, under the

Regulatory Flexibility Act (5 U.S.C.

605(b)), the agency certifies that this

final rule will not have a significant

economic impact on a substantial

number of small entities.

V. Paperwork Reduction Act

This final rule contains no

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.)

VI. References

The following reference has been

placed on display in the Dockets

Management Branch (address above)
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63655

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Cerestar Holding B. V., Mitsubishi

Chemical Corp., and Nikken Chemicals Co.,

‘‘Petition to amend the regulation for 21 CFR

101.80 to authorize a noncariogenicity dental

health claim for the sugar alcohol erythritol

(1,2,3,4-butanetetrol),’’ April 4, 1997, [CP1].

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 101.80 is amended by

revising paragraph (c)(2)(ii)(B) to read as

follows:

§ 101.80 Health claims: dietary sugar

alcohols and dental caries.

* * * * *

(c) * * *

(2) * * *

(ii) * * *

(B) The sugar alcohol in the food shall

be xylitol, sorbitol, mannitol, maltitol,

isomalt, lactitol, hydrogenated starch

hydrolysates, hydrogenated glucose

syrups, erythritol, or a combination of

these.

* * * * *

Dated: November 21, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–31587 Filed 12–1–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety

Administration

23 CFR Part 1327

[Docket No. NHTSA–97–3155]

RIN 2127–AG21

Procedures for Participating in and

Receiving Data From the National

Driver Register Problem Driver Point

System

AGENCY: National Highway Traffic

Safety Administration (NHTSA), DOT.

ACTION: Interim final rule; request for

comments.

SUMMARY: This interim final rule

amends the agency’s National Driver

Register (NDR) regulations to implement

a recent amendment to the National

Driver Register Act of 1982, as amended.

The amendment authorizes the

Commandant of the Coast Guard to

request and receive information from

the National Driver Register (NDR)

regarding the motor vehicle driving

records of any officer, chief warrant

officer, or enlisted member of the Coast

Guard or Coast Guard Reserve

(including a cadet or an applicant for

appointment or enlistment of any of the

foregoing, and any member of a

uniformed service who is assigned to

the Coast Guard). This interim final rule

establishes the procedures for such

individuals to request, and for the

Commandant to receive, NDR

information.

DATES: This interim final rule becomes

effective on December 2, 1997.

Comments on this interim final rule are

due no later than February 2, 1998.

ADDRESSES: Written comments should

refer to the docket number and be

submitted (preferably in ten copies) to:

Department of Transportation—Dockets,

Room PL–401, Nassif Building, 400

Seventh Street, S.W., Washington, DC

20590. (Docket hours are from 10:00

a.m. to 5:00 p.m.)

FOR FURTHER INFORMATION CONTACT: Mr.

William Holden, Chief, Traffic Records

and Driver Register Division, NTS–32.

National Highway Traffic Safety

Administration, 400 Seventh Street,

S.W., Washington, DC 20590; telephone

(202) 366–4800 or Ms. Heidi L.

Coleman, Assistant Chief Counsel for

General Law, NCC–30, National

Highway Traffic Safety Administration,

400 Seventh Street, S.W., Washington,

DC 20590; telephone (202) 366–1834.

SUPPLEMENTARY INFORMATION: The

National Driver Register (NDR) is a

central file of information on

individuals whose licenses to operate a

motor vehicle have been denied,

revoked, suspended, or canceled, for

cause, or who have been convicted of

certain serious traffic-related violations,

such as racing on the highways or

driving while impaired by alcohol or

other drugs.

As provided in the NDR Act of 1982,

as amended, 49 U.S.C. 30301, et seq.,

State chief driver licensing officials are

authorized to request and receive

information from the NDR for driver

licensing and driver improvement

purposes. When an individual applies

for a driver’s license, for example, these

State officials are authorized to request

and receive NDR information to

determine whether the applicant’s

driver’s license has been withdrawn for

cause in any other State. Because the

NDR is a nationwide index, chief driver

licensing officials need to submit only a

single inquiry to obtain this

information.

State chief driver licensing officials

also are authorized under the Act to

request NDR information on behalf of

other authorized NDR users for

transportation safety purposes. The NDR

Act authorizes the following entities to

receive NDR information for limited

transportation purposes: the National

Transportation Safety Board and the

Federal Highway Administration for

accident investigation purposes;

employers and prospective employers of

motor vehicle operators; the Federal

Aviation Administration (FAA)

regarding any individual who holds or

has applied for an airman’s certificate;

air carriers regarding individuals who

are seeking employment with the air

carrier; the Federal Railroad

Administration (FRA) and employers or

prospective employers of locomotive

operators; and the U.S. Coast Guard

regarding any individual who holds or

who has applied for a license, certificate

of registry, or a merchant mariner’s

document. The Act also provides that

individuals can learn whether

information about themselves is on the

NDR file and can receive any such

information.

On October 19, 1996, Pub. L. 104–324

was enacted into law. Section 207 of

that Act contained an amendment to the

NDR Act of 1982, as amended (49 U.S.C.

30305), authorizing the Commandant of

the Coast Guard to request and receive

NDR information regarding any officer,

chief warrant officer, or enlisted

member of the Coast Guard or Coast

Guard Reserve (including a cadet or an

applicant for appointment or enlistment

of any of the foregoing, and any member

of a uniformed service who is assigned

to the Coast Guard).

Procedures for Requesting and

Receiving NDR Information

The procedures that the Commandant

of the Coast Guard would use to receive

NDR information on these Coast Guard

members would be the same as those

used by the U.S. Coast Guard to receive

information regarding individuals who

hold or who have applied for a license,

certificate of registry, or a merchant

mariner’s document.

The Commandant of the Coast Guard

may not initiate a request for NDR

information. Rather, the individual

member or applicant must do so. To

initiate a request, the individual must

either complete, sign and submit a

request for an NDR file search, or