36786 Federal Register / Vol. 65, No. 113 / Monday, June 12, 2000 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 99F–1581]

Indirect Food Additives: 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 imidazolium compounds,

2–(C17 and C17-unsaturated alkyl)-1–[2–

(C18 and C18-unsaturated amido)ethyl]-

4,5-dihydro-1-methyl, methyl sulfates as

a debonding agent in the manufacture of

paper and paperboard intended for use

in contact with aqueous and fatty food

and in contact with dry food. This

action is in response to a petition filed

by Witco Corp.

DATES: This rule is effective June 12,

2000. Submit written objections and

requests for a hearing by July 12, 2000.

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: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

June 4, 1999 (64 FR 30038), FDA

announced that a food additive petition

(FAP 9B4669) had been filed by Witco

Corp., One American Lane, Greenwich,

CT 06831–2559. The petition proposed

to amend the food additive regulations

in § 176.170 Components of paper and

paperboard in contact with aqueous and

fatty foods (21 CFR 176.170) and

§ 176.180 Components of paper and

paperboard in contact with dry food (21

CFR 176.180) to provide for the safe use

of imidazolium compounds, 2–(C17 and

C17-unsaturated alkyl)-[2–(C18 and C18-

unsaturated amido)ethyl]-4,5-dihydro-1-

methyl, methyl sulfates as a debonding

agent in the manufacture of paper

intended for use in contact with food.

The name of the additive was incorrect

in the June 4, 1999, notice, but is being

used correctly as imidazolium

compounds, 2–(C17 and C17-unsaturated

alkyl)-1–[2–(C18 and C18-unsaturated

amido)ethyl]-4,5-dihydro-1-methyl,

methyl sulfates in this document.

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

§§ 176.170 and 176.180 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 carefully considered

the environmental effects of this rule as

announced in the notice of filing for the

petition. 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 July 12, 2000. 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 176

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 part 176 is

amended as follows:

PART 176—INDIRECT FOOD

ADDITIVES: PAPER AND

PAPERBOARD COMPONENTS

1. The authority citation for 21 CFR

part 176 continues to read as follows:

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

379e.

2. Section 176.170 is amended in the

table in paragraph (a)(5) 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.

* * * * *

(a) * * *

(5) * * *

List of substances Limitations

*******

Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1–[2–(C18

and C18-unsaturated amido)ethyl]-4,5-dihydro-1-methyl, methyl

sulfates (CAS Reg. No. 72749–55–4).

For use only at a level not to exceed 0.5 percent by weight of the dry

paper and paperboard.

*******

Federal Register / Vol. 65, No. 113 / Monday, June 12, 2000 / Rules and Regulations 36787

* * * * *

3. 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

*******

Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1–[2–(C18

and C18-unsaturated amido)ethyl]-4,5-dihydro-1-methyl, methyl

sulfates (CAS Reg. No. 72749–55–4).

For use only at levels not to exceed 0.5 percent by weight of the dry

paper and paperboard.

*******

Dated: May 31, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–14700 Filed 6–9–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

New Animal Drugs; Change of

Sponsor’s Address

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor’s address for ADM

Animal Health & Nutrition Division.

DATES: This rule is effective June 12,

2000.

FOR FURTHER INFORMATION CONTACT:

Norman J. Turner, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0214.

SUPPLEMENTARY INFORMATION: ADM

Animal Health & Nutrition Division,

P.O. Box 2508, Fort Wayne, IN 46801–

2508, has informed FDA of a change of

sponsor’s address to 1000 North 30th

St., Box 1C, Quincy, IL 62305–3115.

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

and (c)(2) to reflect the change of

sponsor’s address.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

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 Center for Veterinary Medicine, 21

CFR part 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by revising the

entry for ‘‘ADM Animal Health &

Nutrition Division’’ and in the table in

paragraph (c)(2) by revising the entry for

‘‘017519’’ to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

*******

ADM Animal Health & Nutrition Division, 1000 North 30th St., Box 1C,

Quincy, IL 62305–3115

017519

*******

(2) * * *

Drug labeler code Firm name and address

*******

017519 ADM Animal Health & Nutrition Division, 1000 North 30th St., Box 1C,

Quincy, IL 62305–3115

*******