35798 Federal Register / Vol. 63, No. 126 /Wednesday, July 1, 1998 /Rules and Regulations

1As noted, EHD is reported to be a weak skin

carcinogen in female Swiss mice. This finding does

not mean that EHD is a carcinogenic impurity of the

additive.

If EHD were a carcinogenic impurity, FDA would

evaluate such impurity under the general safety

clause, using risk assessment procedures to

determine whether there is a reasonable certainty of

no harm that would result from the proposed use

of the additive, Scott v. FDA, 728 F. 2d 322 (6th

Cir. 1984).

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Parts 162 and 178

[T.D. 98–49]

RIN 1515–AB98

Prior Disclosure; Correction

AGENCY: Customs Service, Department

of the Treasury.

ACTION: Final rule; correction.

SUMMARY: Customs published in the

Federal Register on May 28, 1998, a

document revising the Customs

Regulations regarding ‘‘prior

disclosure’’. This document contains

corrections to that document.

EFFECTIVE DATE: June 29, 1998.

FOR FURTHER INFORMATION CONTACT:

Robert Pisani, Penalties Branch (202)

927–2344.

SUPPLEMENTARY INFORMATION:

Background

Customs published in the Federal

Register (63 FR 29126) on May 28, 1998,

a document revising the Customs

Regulations regarding ‘‘prior

disclosure’’. That document contained

three technical errors which this

document will correct.

Correction of Publication

Accordingly, the publication on May

28, 1998, of the final rule (T.D. 98–49)

(63 FR 29126) (FR Doc. 98–14154) is

corrected as follows:

1. On page 29132, in the first column,

paragraph (a)(1) of § 162.74 is corrected

to remove the word ‘‘duties’’ and insert

in its place the words ‘‘duties, taxes and

fees’’.

2. On page 29132, in the second

column, paragraph (c) of § 162.74 is

corrected by removing the words

‘‘actual loss of duties’’ in the heading

and wherever it appears in the text and

inserting in their place the words

‘‘actual loss of duties, taxes and fees’’.

Also, paragraph (c) is corrected by

removing the words ‘‘actual duty loss’’

or ‘‘actual loss of duty’’ and inserting in

their place the words ‘‘actual loss of

duties, taxes or fees’’.

3. On page 29132, in the third

column, paragraph (f) of § 162.74 is

corrected by inserting a comma after the

word ‘‘Fines’’ the second time the word

appears in the paragraph.

Dated: June 25, 1998

Joseph W. Clark,

Chief, Regulations Branch Harold M. Singer

[FR Doc. 98–17431 Filed 6–30–98; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F–0305]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

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 expanded safe use of siloxanes and

silicones; cetylmethyl, dimethyl, methyl

11-methoxy-11-oxoundecyl as a pigment

dispersant in all pigmented polymers

intended for use in contact with food.

This action is in response to a petition

filed by Goldschmidt Chemical Corp.

DATES: The regulation is effective July 1,

1998; written objections and requests for

a hearing by July 31, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), 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

July 31, 1997 (62 FR 41053), FDA

announced that a food additive petition

(FAP 7B4550) had been filed by

Goldschmidt Chemical Corp., c/o Keller

and Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001. The

petition proposed to amend the food

additive regulations in § 178.3725

Pigment dispersants (21 CFR 178.3725)

to provide for the expanded safe use of

siloxanes and silicones; cetylmethyl,

dimethyl, methyl 11-methoxy-11-

oxoundecyl as a pigment dispersant in

all pigmented polymers intended for use

in contact with 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

§ 178.3725 should be amended as set

forth below.

Information in the petition indicates

that one of the constituents of the

additive, i.e., hexadecene which is a

starting material for the additive, leads

to the formation in rabbits of a transient

metabolite, 1,2-epoxyhexadecane (EHD).

In a published study, EHD was reported

to be a weak skin carcinogen in female

Swiss mice (Ref. 1). FDA evaluated this

study (Ref. 2) and has concluded that

the evidence that EHD may be a weak

dermal carcinogen in female Swiss mice

does not preclude a conclusion that the

petitioned use of the substance is safe1.

First, the incidence of dermal tumors

in EHD-treated mice was small (2 or 3

of 40 mice) and not statistically

significant, assuming that control

animals had no dermal tumors. Second,

there were deficiencies in the conduct

and reporting of this study. Third,

dermal carcinogenicity is not highly

predictive of carcinogenicity by other

routes of exposure (Ref. 3). These

observations support the agency’s view

that there is no evidence that suggests

that EHD is likely to be a carcinogen

when orally ingested, which is the route

of exposure most directly relevant to the

safety assessment of food additives.

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 determined under 21

CFR 25.31(i) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is 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 on or before July 31, 1998, file with

the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be
Federal Register / Vol. 63, No. 126 /Wednesday, July 1, 1998 /Rules and Regulations 35799

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.

The following references have 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. Van Duuren, B. L., L. Langseth, B. M.

Goldschmidt, and L. Orris, ‘‘Carcinogenicity

of Epoxides, Lactones, and Epoxy

Compounds. VI. Structure and Carcinogenic

Activity,’’ Journal of the National Cancer

Institute, vol. 39, No. 6., pp. 1217–1228,

1967.

2. Memorandum from Executive Secretary

of the Cancer Assessment Committee, FDA,

to Quantitative Risk Assessment Committee,

FDA, concerning ‘‘Potential Carcinogenicity

of 1,2-epoxyhexadecane (EHD): Subject of

Food Additive Petition No. 7B4550

(Goldschmidt Chemical Corp.),’’ dated

January 8, 1998.

3. Tobin, Paul S. et al., ‘‘An Evaluation of

Skin Painting Studies as Determinants of

Tumorigenesis Potential Following Skin

Contact with Carcinogens,’’ Regulatory

Toxicology and Pharmacology, vol. 2, 22–37,

1982.

List of Subjects in 21 CFR Part 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, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

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

2. Section 178.3725 is amended in the

table by alphabetically adding an entry

under the headings ‘‘Substances’’ and

‘‘Limitations’’ to read as follows:

§ 178.3725 Pigment dispersants.

* * * * *

Substances Limitations

* * * * * * *

Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11-methoxy-11-

oxoundecyl (CAS Reg. No. 155419–59–3).

For use only at levels not to exceed 0.5 percent by weight of the pigment. The pigmented polymers may contact all foods under conditions of use C, D, E, F, and G described in Table 2 of § 176.170(c)

of this chapter.

Dated: June 19, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–17412 Filed 6–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 48, 145, and 602

[T.D. 8774]

RIN 1545–AW15

Kerosene Tax; Aviation Fuel Tax; Tax

on Heavy Trucks and Trailers

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Temporary regulations.

SUMMARY: This document contains

temporary regulations relating to the

kerosene and aviation fuel excise taxes

and the tax on the first retail sale of

certain tractors and truck, trailer, and

semitrailer chassis and bodies (heavy

vehicles). The regulations provide rules

for the kerosene tax, the refund

available to certain aviation producers,

and the tax on heavy vehicles. The

regulations relating to kerosene affect

the tax liability of certain industrial

users, refiners, terminal operators,

throughputters, and persons that sell,

buy, or use kerosene. The regulations

relating to aviation fuel affect certain

producers, retailers, and users of

aviation fuel. The regulations relating to

the tax on heavy vehicles affect vehicle

manufacturers and dealers. The text of

these regulations also serves as the text

of the proposed regulations set forth in

the notice of proposed rulemaking on

this subject in the Proposed Rules

section of this issue of the Federal

Register.

DATES: These regulations are effective

July 1, 1998. For dates of applicability,

see §§ 48.4082–6T, 48.4082–7T(b),

48.4082–8T(f), 48.4082–9T(b), 48.4091–

3T(f), 48.4101–3T(e), 48.6427–10T(c),

48.6427–11T(g), and 145.4052–

1(a)(2)(ii).

FOR FURTHER INFORMATION CONTACT:

Frank Boland (202) 622–3130 (not a tollfree call).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

These temporary regulations are being

issued without prior notice and public

procedure pursuant to the

Administrative Procedure Act (5 U.S.C.

553). For this reason, the collection of

information contained in these

regulations has been reviewed and,

pending receipt and evaluation of

public comments, approved by the

Office of Management and Budget under

control number 1545–1608. Responses

to this collection of information are

required to obtain a tax benefit.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless the collection of information

displays a valid OMB control number.

For further information concerning

this collection of information, and

where to submit comments on the

collection of information and the

accuracy of the estimated burden, and

suggestions for reducing this burden,

please refer to the preamble to the

notice of proposed rulemaking in the

Proposed Rules section of this issue of

the Federal Register.