Federal Register / Vol. 66, No. 45 / Wednesday, March 7, 2001 / Rules and Regulations 13653

III. Conclusion

FDA has evaluated the data in the

petition and other relevant material.

Based on this information, the agency

concludes that: (1) The proposed

renaming of the use of the additive is

appropriate provided that related

limitations are added to § 172.133, (2)

the uses of the additive specified in this

section remain safe, (3) the additive will

achieve its intended technical effect,

and therefore, (4) the regulations in

§ 172.133 should be amended as set

forth in this document.

The agency is also taking this

opportunity to correct an inadvertent

error in and to make editorial changes

to § 172.133 in response to the ongoing

initiative regarding plain language in

government writing.

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.

IV. Environmental Impact

The agency determined subsequent to

the amended filing notice of this

petition that the categorical exclusion in

21 CFR 25.30(i) is no longer appropriate.

The agency is relying instead on the

categorical exclusion in 21 CFR 25.32(k)

for this action. Because this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment, neither an

environmental assessment nor an

environmental impact statement is

required.

V. Paperwork Reduction Act 1995

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

VI. Objections

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by April 6, 2001. 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

are to be submitted and are to 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.

List of Subjects in 21 CFR Part 172

Food additives, 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: 21 U.S.C. 321, 341, 342, 348,

371, 379e.

2. Section 172.133 is amended by

redesignating paragraph (c)(2) as

paragraph (c)(3), by adding a new

paragraph (c)(2), and by revising newly

redesignated paragraph (c)(3) and

paragraph (b), to read as follows:

§ 172.133 Dimethyl dicarbonate.

* * * * *

(b) The additive is used or intended

for use as a microbial control agent in

the following beverages under normal

circumstances of bottling, canning, or

other forms of final packaging, where

the viable microbial load has been

reduced to 500 microorganisms per

milliliter or less by current good

manufacturing practices such as heat

treatment, filtration, or other

technologies prior to the use of dimethyl

dicarbonate:

(1) In wine, dealcoholized wine, and

low alcohol wine in an amount not to

exceed 200 parts per million.

(2) In ready-to-drink teas in an

amount not to exceed 250 parts per

million.

(3) In carbonated or noncarbonated,

nonjuice-containing (less than or equal

to 1 percent juice), flavored or

unflavored beverages containing added

electrolytes (5–20 milliequivalents/liter

sodium ion (Na+) and 3–7

milliequivalents/liter potassium ion

(K+)) in an amount not to exceed 250

parts per million.

(4) In carbonated, dilute beverages

containing juice, fruit flavor, or both,

with juice content not to exceed 50

percent, in an amount not to exceed 250

parts per million.

(c) * * *

(2) The intended use of the additive.

(3) Adequate directions for use to

ensure compliance with this section.

Dated: February 20, 2001.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 01–5511 Filed 3–6–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175, 176, and 178

[Docket No. 99F–2081]

Indirect Food Additives: Adhesives

and Components of Coatings and

Paper and Paperboard Components

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 butanedioic acid, sulfo1,4-diisodecyl ester, ammonium salt as

a surface active agent in adhesive

formulations, and in components of

paper and paperboard intended to

contact food. This action is in response

to a petition filed by Troy Corp.

DATES: This rule is effective March 7,

2001. Submit written objections and

requests for a hearing by April 6, 2001.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Mark A. Hepp, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3098.

13654 Federal Register / Vol. 66, No. 45 / Wednesday, March 7, 2001 / Rules and Regulations

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 2, 1999 (64 FR 36021), FDA

announced that a food additive petition

(FAP 9B4678) had been filed by Troy

Corp., c/o S. L. Graham & Associates,

1801 Peachtree Lane, Bowie, MD 20721.

The petition proposed to amend the

food additive regulations in § 175.125

Pressure-sensitive adhesives (21 CFR

175.125) to provide for the safe use of

butanedioic acid, sulfo-1,4-diisodecyl

ester, ammonium salt as a surface active

agent in pressure sensitive adhesives.

Subsequent to the publication of the

filing notice, the petition was amended

to include a proposal to further amend

the food additive regulations in

§§ 175.105 Adhesives (21 CFR 175.105),

176.170 Components of paper and

paperboard in contact with aqueous and

fatty foods (21 CFR 176.170), 176.180

Components of paper and paperboard

in contact with dry food (21 CFR

176.180), and 178.3400 Emulsifiers and/

or surface active agents (21 CFR

178.3400) to provide for the safe use of

butanedioic acid, sulfo-1, 4-diisodecyl

ester, ammonium salt as a surface active

agent in adhesives, and in paper and

paperboard intended to contact food.

Therefore, in a notice published in the

Federal Register of January 3, 2001 (66

FR 375), FDA announced that it was

amending the filing notice of July 2,

1999, to indicate that the petitioner

requests that the food additive

regulations be amended to provide for

the safe use of butanedioic acid, sulfo1,4-diisodecyl ester, ammonium salt as

a surface active agent in adhesives,

pressure sensitive adhesives, and paper

and paperboard intended to contact

food.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe, that the additive will

achieve its intended technical effect,

and therefore, that the regulations in

§§ 175.105, 175.125, 176.170, 176.180,

and 178.3400 should be amended as set

forth below.

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 previously considered

the potential environmental effects of

this rule as announced in the notices of

filing for FAP 9B4678. 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.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by April 6, 2001. 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

are to be submitted and are to 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.

List of Subjects

21 CFR Part 175

Adhesives, Food additives, Food

packaging.

21 CFR Parts 176 and 178

Food additives, Food packaging.

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 parts 175,

176, and 178 are amended as follows:

PART 175—INDIRECT FOOD

ADDITIVES: ADHESIVES AND

COMPONENTS OF COATINGS

1. The authority citation for 21 CFR

part 175 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 175.105 is amended in the

table in paragraph (c)(5) by

alphabetically adding an entry under

the headings ‘‘Substances’’ and

‘‘Limitations’’ to read as follows:

§ 175.105 Adhesives.

* * * * *

(c) * * *

(5) * * *

Substances Limitations

*******

Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also

known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt

[CAS Reg. No. 144093–88–9]).

For use as a surface active agent in adhesives.

*******

3. Section 175.125 is amended by

adding paragraph (a)(9) and by revising

paragraph (b)(1) to read as follows:

§ 175.125 Pressure-sensitive adhesives.

* * * * *

(a) * * *

(9) Butanedioic acid, sulfo-1,4-di-(C9-

C11 alkyl) ester, ammonium salt (also

known as butanedioic acid sulfo-1, 4-

diisodecyl ester, ammonium salt [CAS

Reg. No. 144093–88–9]) as a surface

active agent at a level not to exceed 3.0

percent by weight of the finished

pressure-sensitive adhesive.

(b) * * *

(1) Substances listed in paragraphs

(a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7),

(a)(8), and (a)(9) of this section, and

those substances prescribed by

paragraph (a)(4) of this section that are

not identified in paragraph (b)(2) of this

section.

* * * * *

Federal Register / Vol. 66, No. 45 / Wednesday, March 7, 2001 / Rules and Regulations 13655

PART 176—INDIRECT FOOD

ADDITIVES: PAPER AND

PAPERBOARD COMPONENTS

4. The authority citation for 21 CFR

part 176 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 346, 348,

379e.

5. Section 176.170 is amended in the

table in paragraph (b)(2) by

alphabetically adding an entry under

the headings ‘‘List of Substances’’ and

‘‘Limitations’’ to read as follows:

§ 176.170 Components of paper and

paperboard in contact with aqueous and

fatty foods.

* * * * *

(b) * * *

(2) * * *

List of substances Limitations

*******

Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also

known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt

[CAS Reg. No. 144093–88–9]).

For use as a surface active agent in package coating inks at levels not

to exceed 3 percent by weight of the coating ink.

*******

6. Section 176.180 is amended in the

table in paragraph (b)(2) by

alphabetically adding an entry under

the headings ‘‘List of substances’’ and

‘‘Limitations’’ to read as follows:

§ 176.180 Components of paper and

paperboard in contact with dry food.

* * * * *

(b) * * *

(2) * * *

List of substances Limitations

*******

Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also

known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt

[CAS Reg. No. 144093–88–9]).

For use as a surface active agent in package coating inks at levels not

to exceed 3 percent by weight of the coating ink.

*******

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

7. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

8. Section 178.3400 is amended in the

table in paragraph (c) by alphabetically

adding an entry under the headings

‘‘List of substances’’ and ‘‘Limitations’’

to read as follows:

§ 178.3400 Emulsifiers and/or surface

active agents.

* * * * *

(c) * * *

List of substances Limitations

*******

Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also

known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt

[CAS Reg. No. 144093–88–9]).

For use as a surface active agent as provided in §§ 175.105, 175.125,

176.170, and 176.180 of this chapter.

*******

* * * * *

Dated: February 21, 2001.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 01–5512 Filed 3–6–01; 8:45 am]

BILLING CODE 4160–01–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 82

[FRL–6949–8]

Protection of Stratospheric Ozone:

Notice 14 for Significant New

Alternatives Policy Program;

Correction

AGENCY: Environmental Protection

Agency.

ACTION: Notice of Acceptability,

correction; Request for Information,

correction.

SUMMARY: The Environmental Protection

Agency published in the Federal

Register of December 18, 2000, a Notice

of Acceptability and Request for

Information related to the Significant

New Alternatives Policy (SNAP)

program. A number of typographical

errors were made inadvertently. In

addition, a commenter provided

updated information about the

flammability of one chemical presented

in the notice. This document identifies

and corrects these errors.

DATES: These corrections are effective

on March 7, 2001. Please submit any

information in response to the

December 18, 2000 requests for

information by May 7, 2001.

FOR FURTHER INFORMATION CONTACT:

Margaret Sheppard by telephone at

(202) 564–9163, by fax at (202) 565–

2141, by e-mail at

sheppard.margaret@epa.gov, or by mail

at U.S. Environmental Protection

Agency, Mail Code 6205J, Washington,

D.C. 20460. Overnight or courier

deliveries should be sent to the office

location at 501 3rd Street, N.W.,

Washington, D.C., 20001. Further

information can be found by calling the

Stratospheric Protection Hotline at (800)

296–1996, or by viewing EPA’s Ozone

Depletion World Wide Web site at

www.epa.gov/ozone/title6/snap/.

SUPPLEMENTARY INFORMATION: The

Environmental Protection Agency

published in the Federal Register of

December 18, 2000 (65 FR 78977), a

Notice of Acceptability and Request for

Information related to the Significant