33654 Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Rules and Regulations

desired by the manufacturer. If a

manufacturer elects to use a part or

publication number, it must appear in

the lower right-hand corner of the label

and be set in 6-point type or smaller.

* * * * *

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 96–16476 Filed 6–27–96; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 94F–0405]

Food Additives Permitted for Direct

Addition to Food for Human

Consumption; Aspartame

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of aspartame as a general

purpose sweetener. This action is in

response to a petition by the NutraSweet

Co., and will simplify the existing

regulation by replacing most of the 23

currently listed uses of aspartame with

a single use category for food.

DATES: The regulation is effective June

28, 1996. Submit written objections and

requests for a hearing by July 29, 1996.

The Director of the Office of the Federal

Register approves the incorporation by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51 of a certain

publication in 21 CFR 172.804(c)(2),

effective June 28, 1996.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Blondell Anderson, Center for Food

Safety and Applied Nutrition (HFS–

207), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3106.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

December 8, 1994 (59 FR 63368), FDA

announced that a food additive petition

(FAP 5A4439) had been filed by the

NutraSweet Co., 1751 Lake Cook Rd.,

Deerfield, IL 60015–5239, proposing

that the food additive regulations be

amended in § 172.804 Aspartame (21

CFR 172.804) to provide for the safe use

of aspartame as a general purpose

sweetener.

I. Background

Aspartame is currently approved for

use in a large number of processed foods

under § 172.804 (21 CFR 172.804) (20

permitted uses as a sweetener and 3

permitted uses as a flavor enhancer).

The regulation has resulted from the

approval of 27 separate food additive

petitions (FAP’s).

The acceptable daily intake (ADI) of

50 milligrams per kilogram body weight

per day (mg/kg/day) was established for

aspartame as a result of the agency’s

review of FAP 2A3661, which requested

use of aspartame in carbonated

beverages (48 FR 31376, July 8, 1983).

The ADI is the level of consumption

that has been determined to be safe for

human consumption every day over an

entire lifetime. The agency’s review of

all petitions submitted subsequent to

aspartame’s approval in carbonated

beverages involved primarily: (1) An

assessment of the estimated exposure

from each additional use; and (2) a

determination of whether the

cumulative estimated exposure,

including the newly requested use,

would cause the acceptable daily

intakes for aspartame and for its major

breakdown product, diketopiperazine

(DKP), to be exceeded over a lifetime by

individuals consuming aspartame at the

90th percentile level. The 90th

percentile intake (which represents high

exposure) is the level of consumption at

which 90 percent of the population (a

selected population subgroup)

consumes the ingredient at or below the

indicated value.

NutraSweet is now requesting that the

aspartame regulation be amended to

allow its use as a general purpose

sweetener at levels determined by

current good manufacturing practice

(CGMP). FDA’s CGMP regulation for

food additives requires, among other

things, that the level of an additive used

in food not be higher than that level

required to accomplish the intended

functional effect (21 CFR 172.5(a)(1)).

This level has not, in general, been set

by the agency except when there

appears to be a specific need to do so.

In the case of the agency’s review of

FAP 7A4044, which requested the use

of aspartame in baked goods and baking

mixes, the maximum level of use of

aspartame that would be consistent with

CGMP was set at 0.5 percent by weight

of ready-to-bake products or of finished

formulations prior to baking. In that

decision, the agency imposed a use limit

that can be verified by an analytical

method that is incorporated by reference

into the regulation. That requirement is

maintained in this regulation. For all

other uses of aspartame the agency has

determined that CGMP levels of use

need not be specified.

The practical effect of the amendment

requested in the current petition would

be to simplify the existing regulation in

§ 172.804 by replacing most of the 23

currently listed uses of aspartame with

a single use category for food. As

discussed below, the permitted uses of

aspartame are sufficiently broad that

including any additional category not

allowed by the current regulation will

not cause human exposure to change

significantly.

II. Petition for Use of Aspartame as a

General Purpose Sweetener

To support the proposed amendment,

NutraSweet has submitted a summary of

postmarket aspartame intake surveys

performed by the Market Research Corp.

of America (MRCA) between 1984 and

1992. These surveys (which measure the

actual amount of aspartame consumed

by individuals) track the quantity of

aspartame-sweetened foods that are

consumed over a 2-week period.

According to the July 1991 to June 1992

survey, the intake of aspartame for

individuals who consume aspartame at

the 90th percentile (‘‘eaters only’’) is 3.0

mg/kg/day (6 percent of the ADI) for the

‘‘all ages’’ population group and is 5.2

mg/kg/day (10.4 percent of the ADI) for

children in the 0-month to 5-year-old

subgroups (the groups that consume the

highest amounts of aspartame per kg of

body weight). NutraSweet states in the

petition that aspartame intake from the

potential new uses is not expected to

significantly increase aspartame

consumption above current levels. This

is because: (1) Its intake from the major

use category (e.g., beverages) has

stabilized and the potential new uses

will have, at most, a minor effect on

total consumption; and (2) the permitted

uses of competing high-intensity

sweeteners continue to be broadened.

III. Exposure Estimates

The agency focused its safety

evaluation on whether human exposure

to aspartame as a general purpose

sweetener would exceed the ADI of 50

mg/kg/day; and whether human

exposure to DKP, the aspartame

decomposition product, would exceed

the ADI of 30 mg/kg/day (Ref. 1).

A. Aspartame

In the Commissioner’s 1981 decision

to approve aspartame (46 FR 38285, July

24, 1981), several methods were

described for projecting the level of
Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Rules and Regulations 33655

aspartame consumption. In one method

the agency estimated that if aspartame

replaced all sucrose in the diet of an

average 60 kg individual, the aspartame

consumption would be approximately

8.3 mg/kg/day. In the petition,

Nutrasweet projects an aspartame intake

of 8.1 mg/kg/day for all age groups

when used as a general purpose

sweetener.

The agency has reassessed the

anticipated exposure to aspartame in

light of all the evidence gained since the

earlier approval. Assuming that all

sucrose added to food would be

replaced by aspartame, the agency

estimates that the daily intake would be

8.7 mg/kg/day. Use of other approaches

to estimate consumption also results in

consistent intake estimates that are far

below the ADI (Ref. 1). This shows that

high levels of aspartame intake derived

for different age groups are unlikely to

exceed the ADI if used in food with no

limitations other than CGMP.

B. DKP

Aspartame can partially decompose to

yield DKP in certain food products

when they are heated or stored for

prolonged periods of time. FDA has

previously set an ADI for DKP of 30 mg/

kg/day (48 FR 31376, July 8, 1983). In

order to derive a conservative exposure

to DKP, FDA used the highest exposure

estimate derived for aspartame (based

on the assumption that all sugars added

to food would be replaced with

aspartame). This DKP exposure estimate

does not exceed 10 percent of the ADI

for all age groups and does not exceed

16 percent for the 0- to 5-year-old age

group (Ref. 1) These estimates show that

the ADI for DKP will not be exceeded

when aspartame is used as a general

purpose sweetener.

IV. Comment

The agency received one comment in

response to the filing notice of

December 8, 1994, from the McNeil

Specialty Products Co. (Ref. 2). This

comment raised two points, each of

which is addressed below.

The first point raised by the comment

was that the filing notice failed to

specify that the agency was soliciting

comments on the entire petition, not

just on the environmental assessment.

The comment suggested that the entire

petition should be made available at the

Dockets Management Branch and that a

separate notice should be published in

the Federal Register explicitly

requesting comments on all aspects of

the petition.

Under section 409(b)(5) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 348(b)(5)), FDA is required to

announce the filing of a food additive

petition. Although public notice of a

petition is required, the act is silent

with respect to public comment on a

petition.

Historically, FDA has not placed food

additive petitions on public display

when a notice of filing is published and

knows of no reason why such public

display should be required. The agency

considers comments received consistent

with their relevance to the petitioned

action. Information from the petition

can be obtained through a request made

under the Freedom of Information Act

consistent with 21 CFR part 20.

The second point raised by the

comment was that the petition lacks

information required under § 171.1(c)

(21 CFR 171.1(c)) on the amount of the

additive proposed for use, appropriate

functionality data to support the

additional use categories requested, and

methods to determine the level of the

additive in food. It is further noted in

the comment that if such information

exists in other petitions, § 171.1(b)

allows the petitioner to reference, rather

than resubmit, such information. The

comment points to: (1) Data establishing

functionality and appropriate use levels

and analytical techniques for the newlyrequested approvals are not present in

the current petition and (2) the

petitioner had not specifically

referenced such data; thus, the petition

does not comply with the requirements

found in § 171.1(c). Therefore, the

comment contends that the petition is

deficient and should not have been

accepted for filing, and should be

amended accordingly prior to the

agency taking final action.

The agency disagrees with the

contention that the petition lacks

information required under § 171.1(c).

As stated above in section I. of this

document, aspartame has been

previously approved for use as a

sweetener in a large number of

processed foods. These various

approvals have resulted from the

agency’s consideration of 27 separate

food additive petitions. The approved

uses of aspartame span a wide range of

food matrices and include products

which are stored under a wide variety

of conditions. Data establishing the

functionality and stability of aspartame,

and descriptions of methods for

detecting aspartame in a wide variety of

food products, are contained in either

the 27 petitions or in several Food

Master Files established for aspartame

by the agency. Much of this information

has been discussed in previous Federal

Register documents.

Further, all of these petitions are

specifically referenced in FAP 5A4439.

Therefore, the statement made in the

comment that these petitions are not

specifically referenced in the subject

petition is factually incorrect.

V. Conclusions

FDA has calculated exposure

estimates to aspartame under the

assumption that the sweetener would be

used in food with no limits other than

CGMP. Having considered the results of

these exposure estimates, which were

made using extremely conservative

assumptions (such as, that aspartame

would replace all sugars added to food),

the agency concludes that the use of

aspartame as a general purpose

sweetener will not cause the ADI for

aspartame to be exceeded. The agency

has estimated exposure to DKP (the

major decomposition product of

aspartame) and concludes that the ADI

for DKP will also not be exceeded by its

use as a general purpose sweetener.

Based on these evaluations, the agency

further concludes that the use of

aspartame as a general purpose

sweetener, subject only to CGMP

conditions of use (including a specific

CGMP level of use of 0.5 percent in

baked goods and baking mixes), is safe

and that the regulation for aspartame

should be amended in § 172.804(c) as

set forth below. In addition, § 172.804(b)

is amended to conform to the

requirement of providing three

addresses for methods that are

incorporated by reference, one where

the method may be obtained and two

where it may be examined by the

public.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. 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.
33656 Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Rules and Regulations

Any person who will be adversely

affected by this regulation may at any

time on or before July 29, 1996, file with

the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

VI. References

The following information has been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Memorandum from the Chemistry

Review Branch, FDA, to the Novel

Ingredients Branch, FDA; March 8, 1994.

2. Comment from the McNeil Specialty

Products Co., January 6, 1995.

List of Subjects in 21 CFR Part 172

Food additives, Incorporation by

reference, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 172 is

amended as follows:

PART 172—FOOD ADDITIVES

PERMITTED FOR DIRECT ADDITION

TO FOOD FOR HUMAN

CONSUMPTION

1. The authority citation for 21 CFR

part 172 continues to read as follows:

Authority: Secs. 201, 401, 402, 409, 701,

721 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 342, 348, 371, 379e).

2. Section 172.804 is amended by

revising the introductory text, the

second sentence of paragraph (b), and

paragraph c; by removing paragraph (d)

and redesignating paragraphs (e) and (f)

as paragraphs (d) and (e) to read as

follows:

§ 172.804 Aspartame.

The food additive aspartame may be

safely used in food in accordance with

good manufacturing practice as a

sweetening agent and a flavor enhancer

in foods for which standards of identity

established under section 401 of the act

do not preclude such use under the

following conditions:

* * * * *

(b) * * * Copies are available from

the National Academy Press, 2101

Constitution Ave. NW., Washington, DC

20418, or may be examined at the

Center for Food Safety and Applied

Nutrition’s Library, Food And Drug

Administration, 200 C St. SW., rm.

3321, Washington, DC, or at the Office

of the Federal Register, 800 North

Capitol St. NW., suite 700, Washington,

DC.

(c)(1) When aspartame is used as a

sugar substitute tablet for sweetening

hot beverages, including coffee and tea,

L-leucine may be used as a lubricant in

the manufacture of such tablets at a

level not to exceed 3.5 percent of the

weight of the tablet.

(2) When aspartame is used in baked

goods and baking mixes, the amount of

the additive is not to exceed 0.5 percent

by weight of ready-to-bake products or

of finished formulations prior to baking.

Generally recognized as safe (GRAS)

ingredients or food additives approved

for use in baked goods shall be used in

combination with aspartame to ensure

its functionality as a sweetener in the

final baked product. The level of

aspartame used in these products is

determined by an analytical method

entitled ‘‘Analytical Method for the

Determination of Aspartame and

Diketopiperazine in Baked Goods and

Baking Mixes,’’ October 8, 1992, which

was developed by the Nutrasweet Co.

Copies are available from the Office of

Premarket Approval (HFS–200), Center

for Food Safety and Applied Nutrition,

200 C St. SW., Washington, DC 20204,

or are available for inspection at the

Center for Food Safety and Applied

Nutrition’s Library, Food and Drug

Administration, 200 C St. SW., rm.

3321, Washington, DC 20204, and the

Office of the Federal Register, 800 North

Capitol St. NW., suite 700, Washington,

DC.

* * * * *

Dated: June 18, 1996.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 96–16522 Filed 6–27–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8670]

RIN 1545–AU20

Revision of Section 482 Cost Sharing

Regulations; Correction

AGENCY: Internal Revenue Service,

Treasury.

ACTION: Correction to final regulations.

SUMMARY: This document contains

corrections to final regulations (TD

8670), which were published in the

Federal Register on Monday, May 13,

1996 (61 FR 21955) relating to qualified

cost sharing arrangements.

EFFECTIVE DATE: May 13, 1996.

FOR FURTHER INFORMATION CONTACT: Lisa

Sams, (202) 622–3840 (not a toll-free

number).

SUPPLEMENTARY INFORMATION:

Background

The final regulations that are the

subject of these corrections are under

section 482 of the Internal Revenue

Code.

Need for Correction

As published, the final regulations

contain errors which may prove to be

misleading and are in need of

clarification.

Correction of Publication

Accordingly, the publication of the

final regulations (TD 8670), which are

the subject of FR Doc. 96–11781, is

corrected as follows:

§ 1.482–7 [Corrected]

On page 21956, column 2,

instructional ‘‘Par. 3.’’, is corrected by

revising item g. to read as follows:

g. By redesignating the introductory

text of paragraph (j)(2) following the

heading and paragraphs (j)(2)(i) through

(j)(2)(v) as the introductory text of

paragraph (j)(2)(i) and paragraphs

(j)(2)(i)(A) through (j)(2)(i)(E),