Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 /Rules and Regulations 20313

accomplished in accordance with Boeing

Alert Service Bulletin 747–53A2420, dated

March 26, 1998.

(1) Perform a detailed visual inspection to

detect cracks in accordance with Figure 2 of

the alert service bulletin.

(i) Repeat the detailed visual inspection

thereafter at intervals not to exceed 25 flight

cycles, until the requirements of paragraph

(a)(1)(ii) are accomplished.

(ii) Within 500 flight cycles after

accomplishment of the initial detailed visual

inspection, accomplish paragraph (a)(2) of

this AD.

(2) Perform a one-time open hole high

frequency eddy current (HFEC) inspection to

detect cracks in accordance with Figure 3 of

the alert service bulletin.

Accomplishment of this action constitutes

terminating action for the repetitive

inspection requirements of this AD.

(b) For airplanes that have accumulated

18,000 or more total flight cycles as of the

effective date of this AD: Within 25 flight

cycles after the effective date of this AD,

inspect the upper chord, web, and strap of

the upper deck floor beams at BS 340 through

BS 440 inclusive, and the upper deck floor

beams at BS 500 and BS 520, on the right and

left sides of the airplane, in accordance with

paragraph (b)(1) or (b)(2) of this AD. The

inspections shall be accomplished in

accordance with Boeing Alert Service

Bulletin 747–53A2420, dated March 26,

1998.

(1) Perform a detailed visual inspection to

detect cracks in accordance with Figure 2 of

the alert service bulletin.

(i) Repeat the detailed visual inspection

thereafter at intervals not to exceed 25 flight

cycles, until the requirements of paragraph

(b)(1)(ii) are accomplished.

(ii) Within 250 flight cycles after

accomplishment of the initial detailed visual

inspection, accomplish paragraph (b)(2) of

this AD.

(2) Perform a one-time open hole HFEC

inspection to detect cracks in accordance

with Figure 3 of the alert service bulletin.

Accomplishment of this action constitutes

terminating action for the repetitive

inspection requirements of this AD.

(c) If any cracking is found during any

inspection required by this AD, prior to

further flight, repair in accordance with a

method approved by the Manager, Seattle

Aircraft Certification Office, FAA, Transport

Airplane Directorate.

(d) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Seattle

ACO. Operators shall submit their requests

through an appropriate FAA Principal

Maintenance Inspector, who may add

comments and then send it to the Manager,

Seattle ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(e) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(f) The inspections shall be done in

accordance with Boeing Alert Service

Bulletin 747–53A2420, dated March 26,

1998. This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from Boeing Commercial Airplane Group,

P.O. Box 3707, Seattle, Washington 98124–

2207. Copies may be inspected at the FAA,

Transport Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(g) This amendment becomes effective on

May 11, 1998.

Issued in Renton, Washington, on April 20,

1998.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–10919 Filed 4–23–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 92F–0290]

Indirect Food Additives: Polymers

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 poly(p-oxyphenylene poxyphenylene p-carboxyphenylene)

resins as a component of food-contact

articles intended for repeated use. This

action responds to a petition filed by ICI

Americas, Inc.

DATES: This regulation is effective April

24, 1998; written objections and

requests for a hearing by May 26, 1998.

ADDRESS: 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:

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.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of August 27, 1992 (57 FR

38840), FDA announced that a food

additive petition (FAP 2B4333) had

been filed by ICI Americas, Inc.,

Concord Pike and Murphy Rd.,

Wilmington, DE 19897 (now Victrex

USA, Inc., 601 Willowbrook Lane, West

Chester, PA 19382). The petition

proposed to amend the food additive

regulations to provide for the safe use of

polyetheretherketone resins as articles

or components of articles intended to

contact food. Polyetheretherketone

resins are also known by the chemical

name poly(p-oxyphenylene poxyphenylene p-carboxyphenylene).

The petition stated that the subject

resins are intended only for repeated

use in contact with food.

In its evaluation of the safety of this

additive, FDA has reviewed the safety of

the additive itself and the chemical

impurities that may be present in the

additive resulting from its

manufacturing process. Although the

additive itself has not been shown to

cause cancer, it has been found to

contain minute amounts of

hydroquinone as a byproduct impurity

of its production. Hydroquinone has

been shown to cause cancer in test

animals. Residual amounts of reactants

and byproduct impurities, such as

hydroquinone, are commonly found as

contaminants in chemical products,

including food additives.

II. Determination of Safety

Under section 409(c)(3)(A) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 348(c)(3)(A)), the socalled ‘‘general safety clause,’’ a food

additive cannot be approved for a

particular use unless a fair evaluation of

the evidence establishes that the

additive is safe for that use. FDA’s food

additive regulations (21 CFR 170.3(i))

define safe as ‘‘a reasonable certainty in

the minds of competent scientists that

the substance is not harmful under the

intended conditions of use.’’

The food additives anticancer, or

Delaney, clause (section 409(c)(3)(A))

further of the act (21 U.S.C. 348(c)(3)(A))

further provides that no food additive

shall be deemed safe if it is found to

induce cancer when ingested by man or

animal. Importantly, however, the

Delaney clause applies to the additive

itself and not to impurities in the

additive. That is, where an additive

itself has not been shown to cause

cancer, but contains a carcinogenic

impurity, the additive is properly

evaluated under the general safety

standard using risk assessment

procedures to determine whether there

is a reasonable certainty that no harm

will result from the intended use of the

additive (Scott v. FDA, 728 F.2d. 322

(6th Cir. 1984)).
20314 Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 /Rules and Regulations

III. Safety of Petitioned Use of the

Additive

FDA estimates that the petitioned use

of the additive, poly(p-oxyphenylene poxyphenylene p-carboxyphenylene),

will result in exposure to no greater

than 0.75 parts per billion of oligomers

derived from the additive in the daily

diet (3 kilograms) or an estimated daily

intake (EDI) of 2.3 micrograms per

person per day (Ref. 1).

FDA does not ordinarily consider

chronic toxicological studies to be

necessary to determine the safety of an

additive whose use will result in such

low exposure levels (Ref. 2), and the

agency has not required such testing

here. However, the agency has reviewed

the available toxicological data on the

additive and concludes that the

estimated dietary exposure resulting

from the petitioned use of this additive

is safe.

FDA has evaluated the safety of this

additive under the general safety

standard, considering all available data

and using risk assessment procedures to

estimate the upper-bound limit of

lifetime human risk presented by

hydroquinone, the carcinogenic

chemical that may be present as an

impurity in the additive. The risk

evaluation of hydroquinone has two

aspects: (1) Assessment of exposure to

the impurity from the petitioned use of

the additive; and (2) extrapolation of the

risk observed in the animal bioassays to

the conditions of exposure to humans.

A. Hydroquinone

FDA has estimated the exposure to

hydroquinone from the petitioned use of

the additive as a component of repeateduse articles intended to contact food to

be no more than 0.4 part per trillion in

the daily diet, or 1.2 nanograms (ng)/

person/day (Ref. 1). The agency used

data from 1989 National Toxicology

Program rodent bioassays on

hydroquinone (Ref. 3), and a 1991

publication by Shibata et al.

summarizing results of rodent bioassays

on hydroquinone (Ref. 4), to estimate

the upper-bound limit of lifetime

human risk from exposure to this

chemical resulting from the petitioned

use of the additive. The agency has

made an assumption that the results of

these studies demonstrate that

hydroquinone produced tumors in male

and female rats and mice following oral

administration for 2 years.

Based on the agency’s estimate that

exposure to hydroquinone will not

exceed 1.2 ng/person/day, FDA

estimates that the upper-bound limit of

lifetime human risk from the petitioned

use of the subject additive is 1x10-10, or

1 in 10 billion (Ref. 5). Because of the

numerous conservative assumptions

used in calculating the exposure

estimate, the actual lifetime-averaged

individual exposure to hydroquinone is

likely to be substantially less than the

estimated exposure, and therefore, the

probable lifetime human risk would be

less than the upper-bound limit of

lifetime human risk. Thus, the agency

concludes that there is reasonable

certainty that no harm from exposure to

hydroquinone would result from the

petitioned use of the additive.

B. Need for Specifications

The agency has also considered

whether specifications are necessary to

control the amount of hydroquinone

present as an impurity in the additive.

The agency finds that specifications are

not necessary for the following reasons:

(1) Because of the low levels at which

hydroquinone may be expected to

remain as an impurity following

production of the additive, the agency

would not expect the impurity to

become a component of food at other

than extremely low levels; and (2) the

upper-bound limit of lifetime human

risk from exposure to the impurity is

very low (1 in 10 billion).

IV. Conclusion

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 as a component of repeated-use

articles intended for contact with food

is safe, and that it will achieve its

intended technical effect. The agency

has also determined, with the

petitioner’s concurrence, that the

additive should be listed by the

chemical name, poly(p-oxyphenylene poxyphenylene p-carboxyphenylene).

Therefore, the agency concludes that a

new § 177.2415 (21 CFR 177.2415)

should be added to 21 CFR part 177 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.

V. Environmental Impact

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.

VI. References

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. Memorandum dated January 30,1997,

from the Chemistry and Environmental

Review Team (HFS–207) to the Indirect

Additive Branch (HFS–216) entitled ‘‘FAP

2B4333 (MATS# 659, M2.5)—Victrex USA,

Inc., Polyetheretherketone (PEEK) as a

component of food-contact articles intended

for repeat-use. Submission dated 8/9/96.’’

2. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology’’ in Chemical Safety

Regulation and Compliance, edited by F.

Homburger, J. K. Marquis, and S. Karger,

New York, pp 24–33, 1985.

3. ‘‘Toxicology and Carcinogenesis Studies

of Hydroquinone (CAS No. 123–31–9) in

F344/N Rats and B6C3F1 Mice (Gavage

Studies)’’ National Toxicology Program,

Technical Report Series, No. 366.

4. Shibata, M. A., M. Hirose, H. Tanaka, E.

Asakawa, T. Shirai, and M. Ito, ‘‘Induction of

renal cell tumors in rats and mice, and the

enhancement of hepatocellular tumor

development in mice after long-term

hydroquinone treatment’’ Japanese Journal of

Cancer Research, 82:1211–1219, 1991.

5. Memorandum dated November 18, 1997,

from Division of Health Effects Evaluation

(HFS–225), to the Chairman of the

Quantitative Risk Assessment Committee

(HFS–308) entitled ‘‘Worst-case cancer risk

assessment for hydroquinone.’’

VII. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before May 26, 1998, 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
Federal Register / Vol. 63, No. 79 / Friday, April 24, 1998 /Rules and Regulations 20315

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.

List of Subjects in 21 CFR Part 177

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 177 is

amended as follows:

PART 177—INDIRECT FOOD

ADDITIVES: POLYMERS

1. The authority citation for 21 CFR

part 177 continues to read as follows:

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

2. Section 177.2415 is added to

subpart C to read as follows:

§ 177.2415 Poly(aryletherketone) resins.

Poly(aryletherketone) resins identified

in paragraph (a) of this section may be

safely used as articles or components of

articles intended for repeated use in

contact with food subject to the

provisions of this section.

(a) Identity. For the purposes of this

section, poly(aryletherketone) resins are

poly(p-oxyphenylene p-oxyphenylene

p-carboxyphenylene) resins (CAS Reg.

No. 29658–26–2) produced by the

polymerization of hydroquinone and

4,4′-difluorobenzophenone, and have a

minimum weight-average molecular

weight of 12,000, as determined by gel

permeation chromatography in

comparison with polystyrene standards,

and a minimum mid-point glass

transition temperature of 142 °C, as

determined by differential scanning

calorimetry.

(b) Optional adjuvant substances. The

basic resins identified in paragraph (a)

may contain optional adjuvant

substances used in their production.

These adjuvants may include substances

described in § 174.5(d) of this chapter

and the following:

Substance Limitations

Diphenyl sulfone Not to exceed 0.2 percent by weight as a residual solvent in the finished basic resin.

(c) Extractive limitations. The

finished food contact article, when

extracted at reflux temperatures for 2

hours with the following four solvents,

yields in each extracting solvent net

chloroform soluble extractives not to

exceed 0.05 milligrams per square inch

of food contact surface: Distilled water,

50 percent (by volume) ethanol in

distilled water, 3 percent acetic acid in

distilled water, and n-heptane. In testing

the final food contact article, a separate

test sample shall be used for each

extracting solvent.

Dated: April 16, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–10969 Filed 4–23–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Part 50

[Public Notice 2780]

Nationality Procedures

AGENCY: Bureau of Consular Affairs,

Department of State.

ACTION: Final rule; correction.

SUMMARY: This document contains

corrections to the final regulations

published in the Federal Register of

Wednesday, June 12, 1996 (61 FR

29651). The regulations related to State

Department Nationality Procedures. A

misprint occurred which omitted part of

one sentence. This correction adds the

omitted language. This correction also

updates the citation of authorities for

Part 50.

DATES: Effective upon April 24, 1998.

FOR FURTHER INFORMATION CONTACT:

Edward A. Betancourt, or Michael

Meszaros, Overseas Citizens Services,

Department of State, 202–647–3666.

SUPPLEMENTARY INFORMATION: In the

final rule published on June 12, 1996,

the Department revised its procedures

concerning loss of nationality. 22 CFR

50.40 describes certain acts for which

citizens need not submit evidence of

intent to retain U.S. nationality. Because

of an error, the last part of the second

sentence in 22 CFR 50.40 was omitted.

This correction adds the missing

sentence. In addition, in the authorities,

citations to current sections of the

United States Code replace original

citations.

PART 50—NATIONALITY

PROCEDURES

Accordingly, 22 CFR Part 50 is

corrected as follows:

1. The authority section for 22 CFR

Part 50 is revised to read as follows:

Authority: 22 U.S.C. 211a, 22 U.S.C. 2051a,

2705, 8 U.S.C. 1104, 1503.

2. In § 50.40(a), add the following in

the second sentence after the first

occurrence of the word ‘‘U.S.’’: ‘‘citizens

who naturalize in a foreign country; take

a routine oath of allegiance; or accept

non-policy level employment with a

foreign government need not submit’’.

Dated: April 15, 1998.

Donna Hamilton,

Acting Assistant Secretary for Consular

Affairs.

[FR Doc. 98–10904 Filed 4–23–98; 8:45 am]

BILLING CODE 4710–06–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CT18–1–7204a; A–1–FRL–5999–2]

Approval and Promulgation of Air

Quality Implementation Plans;

Connecticut; Alternative Reasonably

Available Control Technology for

Volatile Organic Compounds at Risdon

Corporation in Danbury

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving a State

Implementation Plan (SIP) revision

submitted by the State of Connecticut.

This revision allows an alternative

reasonably available control technology

(RACT) determination for volatile

organic compound (VOC) emissions at

Risdon Corporation’s Danbury facility

which are subject to Connecticut’s

miscellaneous metal parts and products

VOC RACT regulations. The intended

effect of this action is to approve the