26740 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations

02, dated May 28, 1998; or McDonnell

Douglas Alert Service Bulletin MD90–

25A019, dated February 11, 1997; as

applicable. 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 Aircraft Group,

Long Beach Division, 3855 Lakewood

Boulevard, Long Beach, California 90846,

Attention: Technical Publications Business

Administration, Dept. C1–L51 (2–60). Copies

may be inspected at the FAA, Transport

Airplane Directorate, 1601 Lind Avenue,

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

Transport Airplane Directorate, Los Angeles

Aircraft Certification Office, 3960 Paramount

Boulevard, Lakewood, California; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(f) This amendment becomes effective on

June 13, 2000.

Issued in Renton, Washington, on April 19,

2000.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 00–10288 Filed 5–8–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 30029; Amdt. No. 422]

IFR Altitudes; Miscellaneous

Amendments

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule.

SUMMARY: This amendment adopts

miscellaneous amendments to the

required IFR (instrument flight rules)

altitudes and changeover points for

certain Federal airways, jet routes, or

direct routes for which a minimum or

maximum en route authorized IFR

altitude is prescribed. This regulatory

action is needed because of changes

occurring in the National Airspace

System. These changes are designed to

provide for the safe and efficient use of

the navigable airspace under instrument

conditions in the affected areas.

EFFECTIVE DATE: 0901 UTC, June 10,

2000.

FOR FURTHER INFORMATION CONTACT:

Donald P. Pate, Flight Procedure

Standards Branch (AMCAFS–420),

Flight Technologies and Programs

Division, Flight Standards Service,

Federal Aviation Administration, Mike

Monroney Aeronautical Center, 6500

South MacArthur Blvd. Oklahoma City,

OK. 73169 (Mail Address: P.O. Box

25082 Oklahoma City, OK. 73125)

telephone: (405) 954–4164.

SUPPLEMENTARY INFORMATION: This

amendment to part 95 of the Federal

Aviation Regulations (14 CFR part 95)

amends, suspends, or revokes IFR

altitudes governing the operation of all

aircraft in flight over a specified route

or any portion of that route, as well as

the changeover points (COPs) for

Federal airways, jet routes, or direct

routes as prescribed in part 95.

The Rule

The specified IFR altitudes, when

used in conjunction with the prescribed

changeover points for those routes,

ensure navigation aid coverage that is

adequate for safe flight operations and

free of frequency interference. The

reasons and circumstances that create

the need for this amendment involve

matters of flight safety and operational

efficiency in the National Airspace

System, are related to published

aeronautical charts that are essential to

the user, and provide for the safe and

efficient use of the navigable airspace.

In addition, those various reasons or

circumstances require making this

amendment effective before the next

scheduled charting and publication date

of the flight information to assure its

timely availability to the user. The

effective date of this amendment reflects

those considerations. In view of the

close and immediate relationship

between these regulatory changes and

safety in air commerce, I find that notice

and public procedure before adopting

this amendment are impracticable and

contrary to the public interest and that

good cause exists for making the

amendment effective in less than 30

days.

Conclusion

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary to keep them operationally

current. It, therefore—(1) is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. For the same

reason, the FAA certifies that this

amendment will not have a significant

economic impact on a substantial

number of small entities under the

criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 95

Airspace Navigation (air).

Issued in Washington, D.C. on May 3,

2000.

L. Nicholas Lacey,

Director, Flight Standards Service.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, part 95 of the Federal

Aviation Regulations (14 CFR part 95) is

amended as follows effective at 0901

UTC.

PART 95—[AMENDED]

1. The authority citation for part 95

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40106,

40113, 40114, 40120, 44502, 44514, 44719,

44721.

2. Part 95 is amended to read as

follows:

REVISIONS TO IFR ALTITUDES AND CHANGEOVER POINTS

[Amendment 422 Effective Date: June 15, 2000]

From To MEA

Color Routes

§ 95.10 Amber Federal Airway 7 Is Added To Read

Campbell Lake, AK NDB .............................................................. Mineral Creek AK NDB ................................................................ 12,100

Color Routes

§ 95.60 Blue Federal Airway 2 Is Added to Read

Point Lay, AK NDB ....................................................................... Cape Lisburne, AK NDB/DME ..................................................... 4,000

Cape Lisbune, AK NDB/DME ....................................................... Hotham, AK NDB ......................................................................... *8,000

Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations 26741

REVISIONS TO IFR ALTITUDES AND CHANGEOVER POINTS—Continued

[Amendment 422 Effective Date: June 15, 2000]

From To MEA

*4,100–MOCA

Hotham, AK NDB .......................................................................... Tin City, AK NDB/DME ................................................................ *5,000

*4,300–MOCA

Tin City, AK NDB/DME ................................................................. Fort Davis, AK NDB ..................................................................... *7,000

*5,900–MOCA

Color Routes

§ 95.60 Blue Federal Airway 4 Is Added To Read

Bishop, AK NDB ............................................................................ Utopia Creek, AK NDB ................................................................ *7,000

*5,900–MOCA

Utopia Creek, AK NDB ................................................................. Evansville, AK NDB ..................................................................... *8,000

Evansville, AK NDB ...................................................................... Yukon River, AK NDB ................................................................. *8,000

*6,600–MOCA

Color Routes

§ 95.60 Blue Federal Airway 5 Is Added To Read

Cape Lisburne, AK NDB/DME ...................................................... Point Hope, AK NDB ................................................................... 4,000

Color Routes

§ 95.60 Blue Federal Airway 8 Is Added To Read

Tin City, AK NDB/DME ................................................................. Shishmaref, AK NDB ................................................................... 4,000

Color Routes

§ 95.4 Green Federal Airway 1 Is Added To Read

Mount Moffett, AK NDB/DME ....................................................... Horth, AK FIX .............................................................................. 8,000

*2,500–MOCA

Horth, AK FIX ................................................................................ Mordi, AK FIX .............................................................................. *8,000

Mordi, AK FIX ................................................................................ Elfee, AK NDB ............................................................................. *8,000

Color Routes

§ 95.4 Green Federal Airway 4 Is Added To Read

Borland, AK NDB/DME ................................................................. Woody Island, AK NDB ............................................................... *10,000

Color Routes

§ 95.4 Green Federal Airway 4 Is Added To Read

Wood River, AK NDB .................................................................... Iliamna, AK NDB/DME ................................................................. *4,500

*3,000–MOCA

Color Routes

§ 95.56 Green Federal Airway 16 Is Added To Read

Point Lay, AK NDB ....................................................................... Wainwright Village, AK NDB ....................................................... *1,700

*1,200–MOCA

Wainwright Village, AK NDB ......................................................... Browerville, AK NDB .................................................................... *1,600

*1,100–MOCA

Browerville, AK NDB ..................................................................... Nuiqsut Village, AK NDB ............................................................. 1,600

Nuiqsut Village, AK NDB .............................................................. Put River, AK NDB ...................................................................... *1,700

*1,200–MOCA

Color Routes

§ 95.57 Green Federal Airway 17 Is Added To Read

Wainwright Village, AK NDB ......................................................... Atqasuk, AK NDB ........................................................................ *1,600

*1,100–MOCA

Color Routes

§ 95.58 Green Federal Airway 18 Is Added To Read

Hotham, AK NDB .......................................................................... Point Lay, AK NDB ...................................................................... *10,000

*6,000–MOCA 0

Point Lay, AK NDB ....................................................................... Atqasuk, AK NDB ........................................................................ 2,300

Color Routes

§ 95.20 Red Federal Airway 1 Is Added To Read

St Paul Island, AK NDB/DME ....................................................... Garrs, AK FIX .............................................................................. *4,600

26742 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations

REVISIONS TO IFR ALTITUDES AND CHANGEOVER POINTS—Continued

[Amendment 422 Effective Date: June 15, 2000]

From To MEA

*2,700–MOCA

Garrs, AK FIX ................................................................................ Saldo, AK NDB ............................................................................ 4,600

Color Routes

§ 95.20 Red Federal Airway 2 Is Added To Read

Elfee, AK NDB .............................................................................. Port Heiden, AK NDB/DME ......................................................... 6,000

§ 95.6001 Victor Routes—U.S.

§ 95.6004 VOR Federal Airway 4 Is Amended To Read in Part

Saden, MO FIX ............................................................................. St Louis, MO VORTAC ................................................................ *2,400

*1,700–MOCA

§ 95.6013 VOR Federal Airway 13 Is Amended To Read in Part

Farmington, MN VORTAC ............................................................ *Wagnr, MN FIX .......................................................................... 5,500

*5,500–MRA

Wagner, MN FIX ........................................................................... Cinci, MN FIX .............................................................................. 5,500

§ 95.6077 VOR Federal Airway 77 Is Amended To Read in Part

Topeka, KS VORTAC ................................................................... St Joseph, MO VORTAC ............................................................. 3,000

§ 95.6159 VOR Federal Airway 159 Is Amended To Read in Part

Vero Beach, FL VORTAC ............................................................. *Presk, FL FIX ............................................................................. 2,900

*2,500–MRA

Presk, FL FIX ................................................................................ Orlando, FL VORTAC .................................................................. *2,100

*1,500–MOCA

§ 95.6189 VOR Federal Airway 189 Is Amended To Read in Part

Wright Brothers, NC VOR/DME .................................................... Darez, NC FIX ............................................................................. *6,000

*1,300–MOCA

Darez, NC FIX ............................................................................... Tar River, NC VORTAC .............................................................. *4,000

*2,600–MOCA

§ 95.6222 VOR Federal Airway 222 Is Amended To Read in Part

Lake Charles, LA VORTAC .......................................................... Maxon, LA FIX ............................................................................. *2,000

*1,500–MOCA

Maxon, LA FIX .............................................................................. *Wrack, LA FIX ............................................................................ **6,000

*3,000–MRA

**1,600–MOCA

Wrack, LA FIX ............................................................................... Mc Comb, MS VORTAC .............................................................. *3,000

*2,000–MOCA

§ 95.6469 VOR Federal Airway 469 Is Amended To Read in Part

Relee, VA FIX ............................................................................... Exras, VA FIX .............................................................................. *8,000

*5,200–MOCA

Exras, VA FIX ............................................................................... Brucy, VA FIX .............................................................................. *10,000

*6,100–MOCA

§ 95.6552 VOR Federal Airway 552 Is Amended To Read in Part

Lake Charles, LA VORTAC .......................................................... Hatha, LA FIX .............................................................................. *2,000

*1,500–MOCA

Hatha, LA FIX ............................................................................... Lafayette, LA VORTAC ............................................................... 2,800

§ 95.6412 Hawaii VOR Federal Airway 12 Is Amended To Read in Part

Maggi, HI FIX ................................................................................ *Shark, HI FIX NE BND

*16,000–MRA ......................................................................... .

**1,200–,MOCA ...................................................................... .

Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations 26743

From To MEA MAA

§ 95.7001 Jet Routes

§ 95.7056 Jet Route No. 56 Is Amended To Read in Part

Salt Lake City, UT VORTAC ............................................ HAYDEN, CO VOR/DME ................................................. 25000 45000

# MEA is established with a Gap in navigation signal coverage.

§ 95.7600 Jet Route No. 600 Is Added To Read

Mount Moffett, AK NDB/DME ........................................... EL/FEE, AK NDB ............................................................. 18000 45000

§ 95.7601 Jet Route No. 601 Is Added To Read

Port Heiden, AK NDB/DME .............................................. Cold Bay, AK VORTAC ................................................... 18000 45000

Cold Bay, AK VORTAC .................................................... St Paul Island, AK NDB/DME .......................................... 18000 45000

§ 95.7603 Jet Route No. 603 Is Added To Read

Elfee, AK NDB .................................................................. Dillingham, AK VOR/DME ................................................ 18000 45000

§ 95.7604 Jet Route No. 604 Is Added To Read

Borland, AK NDB/DME ..................................................... Woody Island, AK NDB .................................................... 18000 45000

§ 95.7605 Jet Route No. 605 Is Added To Read

Biorka Island, AK VORTAC .............................................. Middleton Island, AK VOR/DME ...................................... 23000 45000

§ 95.7606 Jet Route No. 606 Is Added To Read

St Paul Island, AK NDB/DME ........................................... Saldo, AK NDB ................................................................ 180000 45000

§ 95.7617 Jet Route No. 617 Is Added To Read

Homer, AK VORTAC ........................................................ Johnstone Point, AK VORTAC ........................................ 18000 45000

§ 95.7619 Jet Route No. 619 Is Added To Read

Cape Newenham, AK NDB .............................................. St Paul Island, AK NDB/DME .......................................... 18000 45000

§ 95.7711 Jet Route No. 711 Is Added To Read

Sitka, AK NDB .................................................................. Laire, AK FIX .................................................................... 18000 45000

Laire, AK FIX .................................................................... Hinchinbrook, AK NDB ..................................................... 18000 45000

From To

Changeover Points

Distance From

§ 95.8005 Jet Routes Changeover Points Airway Segment Is Added to Read

J627

Homer, AK VORTAC ........................................................ Johnstone Pointe AK VORTAC ....................................... 63 Homer

95.1001 Direct Routes—U.S. Changover Points Color Routes Airway Segment is Added to Read

A7

Campbell Lake, AK NDB .................................................. Mineral Creek, AK NDB ................................................... 69 Campbell

Lake

B2

Cape Lisburne, AK NDB ................................................... Hotham, AK NDB ............................................................. 57 Cape

Lisburne

G16

Browerville, AK NDB ......................................................... Nuiqsut, AK NDB ............................................................. 82 Browerville,

AK NDB

G18

Hotham, AK NDB .............................................................. Point Lay, AK NDB .......................................................... 96 Hotham,

AK, NDB

Point Lay, AK NDB ........................................................... Atqasuk, AK NDB ............................................................. 50 Point Lay,

AK NDB

26744 Federal Register / Vol. 65, No. 90 / Tuesday, May 9, 2000 / Rules and Regulations

[FR Doc. 00–11579 Filed 5–8–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 98F–1019]

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 polyurethane resins

manufactured from diphenylmethane

diisocyanate, 1,4-butanediol, and adipic

acid as a component of cap liners used

on bottles in contact with food. This

action responds to a petition filed by BF

Goodrich Specialty Chemicals.

DATES: This rule is effective May 9,

2000. Submit written objections and

requests for a hearing by June 8, 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:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

205), Food and Drug Administration,

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

202–418–3086.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 30, 1998 (63 FR 65793), FDA

announced that a food additive petition

(FAP 8B4631) had been filed by BF

Goodrich Specialty Chemicals, 9911

Brecksville Rd., Cleveland, OH 44141.

The petition proposed to amend the

food additive regulations in § 177.1210

Closures with sealing gaskets for food

containers (21 CFR 177.1210) to provide

for the safe use of polyurethane resins

manufactured from diphenylmethane

diisocyanate, 1,4-butanediol, and adipic

acid as a component of cap liners used

on bottles in contact with food.

In its evaluation of the safety of these

resins, FDA has reviewed the safety of

the additive itself, the starting materials

used, 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 residual amounts of

methylene dianiline (MDA), which has

been shown to cause cancer in test

animals. MDA is produced when

diphenylmethane diisocyanate (MDI), a

starting material used in the

manufacture of polyurethane resins,

reacts with water. Residual amounts of

reactants and manufacturing aids, such

as MDA, are commonly found as

contaminants in chemical products,

including food additives.

I. Determination of Safety

Under the general safety standard of

section 409(c)(3)(A) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 348(c)(3)(A)), a food additive

cannot be approved for a particular use

unless a fair evaluation of the data

available to FDA 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 of the act (section

409(c)(3)(A)) 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 the

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)).

II. Safety of Petitioned Use of the

Additive

The petitioner determined the levels

of three migrants extracted from the

additive, polyurethane resins

manufactured from MDI, 1,4-butanediol,

and adipic acid. These three migrants

were 1,4-butanediol, oligomers of the

additive, and MDA (the hydrolysis

product of MDI). FDA agrees that the

determination of the levels of these

three types of migrants are appropriate

to evaluate the safe use of the additive.

FDA estimates that the petitioned use of

the additive will result in exposure to

1,4-butanediol of not more than 90

micrograms per person per day (μg/p/d)

while exposure to the other two

migrants will be even lower (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 MDA,

the carcinogenic chemical that may be

present as an impurity in the additive.

This risk evaluation of MDA 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 bioassay to

the conditions of probable exposure to

humans.

A. Methylene Dianiline

FDA has estimated the exposure to

MDA from the petitioned use of the

additive in the manufacture of cap

liners intended to contact food to be no

more than 4.1 parts per trillion in the

daily diet, or 0.012 μg/p/d (Refs. 1 and

5). The agency used data from a

bioassay of MDA, sponsored by the

National Toxicology Program, to

estimate the upper-bound limit of

lifetime human risk from exposure to

MDA that may result from the proposed

use of the additive (Ref. 3). The bioassay

report showed that MDA ingestion

produced tumors at multiple sites in

both sexes of rats and mice.

Based on the agency’s estimate that

exposure to MDA will not exceed 0.012

μg/p/d, FDA estimates that the upperbound limit of lifetime human risk for

MDA from the petitioned use of the

subject additive is 1 x 10-8 or 1 in 100

million (Ref. 4). Because of numerous

conservative assumptions used in

calculating the exposure estimate, the

actual lifetime-averaged individual

exposure to MDA 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 MDA would

result from the petitioned use of the

additive.

B. Need for Specifications

The agency also has considered

whether specifications are necessary to

control the amount of MDA present as

an impurity in the additive. The agency

finds that the specifications are not

necessary for the following reasons: (1)