10240 Federal Register / Vol. 62, No. 44 / Thursday, March 6, 1997 / Proposed Rules

14 CFR Part 39

[Docket No. 86–CE–23–AD]

RIN 2120–AA64

Airworthiness Directives; Pilatus

Britten-Norman Ltd. (formerly BrittenNorman) BN2A MK. 111 Series

Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes to

revise AD 86–07–02, which currently

requires repetitively inspecting the

junction of the torque link lug and

upper case of the main landing gear

(MLG) torque link assemblies for cracks

on Pilatus Britten-Norman Ltd. (Pilatus

Britten-Norman) BN–2A, BN–2B, BN–

2T, and BN2A MK. 111 series airplanes,

and replacing any part found cracked

with a like part. The proposed AD

would remove from the applicability the

BN–2A, BN–2B, and BN–2T series

airplanes, and would retain the

repetitive inspection and replacement

(if necessary) requirements of AD 86–

07–02 for the BN2A MK. 111 series

airplanes. The proposed AD results from

the Federal Aviation Administration’s

determination that additional AD action

needs to be taken on the BN–2A, BN–

2B, and BN–2T series airplanes. This

additional action will be addressed in a

separate AD. The actions specified by

the proposed AD are intended to

prevent failure of the main landing gear

caused by cracks in the torque link area,

which could lead to loss of control of

the airplane during landing operations.

DATES: Comments must be received on

or before May 12, 1997.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Central Region,

Office of the Assistant Chief Counsel,

Attention: Rules Docket No. 86–CE–23–

AD, Room 1558, 601 E. 12th Street,

Kansas City, Missouri 64106. Comments

may be inspected at this location

between 8 a.m. and 4 p.m., Monday

through Friday, holidays excepted.

Service information that applies to the

proposed AD may be obtained from

Pilatus Britten-Norman Limited,

Bembridge, Isle of Wight, United

Kingdom PO35 5PR; telephone 44–1983

872511; facsimile 44–1983 873246. This

information also may be examined at

the Rules Docket at the address above.

FOR FURTHER INFORMATION CONTACT: Mr.

Tom Rodriguez, Program Officer,

Brussels Aircraft Certification Division,

FAA, Europe, Africa, and Middle East

Office, c/o American Embassy, B–1000

Brussels, Belgium; telephone (32 2)

508.2717; facsimile (32 2) 230.6899; or

Mr. S.M. Nagarajan, Project Officer,

Small Airplane Directorate, Airplane

Certification Service, FAA, 1201

Walnut, suite 900, Kansas City, Missouri

64106; telephone (816) 426–6932;

facsimile (816) 426–2169.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Communications

should identify the Rules Docket

number and be submitted in triplicate to

the address specified above. All

communications received on or before

the closing date for comments, specified

above, will be considered before taking

action on the proposed rule. The

proposals contained in this notice may

be changed in light of the comments

received.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the proposed rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this

proposal will be filed in the Rules

Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this notice

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket No. 86-CE–23-AD.’’ The postcard

will be date stamped and returned to the

commenter.

Availability of NPRM’s

Any person may obtain a copy of this

NPRM by submitting a request to the

FAA, Central Region, Office of the

Assistant Chief Counsel, Attention:

Rules Docket No. 86-CE–23-AD, Room

1558, 601 E. 12th Street, Kansas City,

Missouri 64106.

Discussion

The FAA has determined that reliance

on critical repetitive inspections on

aging commuter-class airplanes carries

an unnecessary safety risk when a

design change exists that could

eliminate or, in certain instances,

reduce the number of those critical

inspections. In determining what

inspections are critical, the FAA

considers (1) the safety consequences if

the known problem is not detected

during the inspection; (2) the

probability of the problem not being

detected during the inspection; (3)

whether the inspection area is difficult

to access; and (4) the possibility of

damage to an adjacent structure as a

result of the problem.

These factors have led the FAA to

establish an aging commuter-class

aircraft policy that requires

incorporating a known design change

when it could replace a critical

repetitive inspection. With this policy

in mind, the FAA conducted a review

of existing AD’s that apply to Pilatus

Britten-Norman BN–2A, BN–2B, BN–2T,

and BN2A MK. 111 series airplanes.

Assisting the FAA in this review were

(1) Pilatus Britten-Norman; (2) the

Regional Airlines Association (RAA); (3)

the Civil Aviation Authority of the

United Kingdom; and (4) several

operators of the affected airplanes.

From this review, the FAA has

identified AD 86–07–02,

Amendment39–5382, as one which falls

under the FAA’s aging aircraft policy.

AD 86–07–02 currently requires

repetitively inspecting the junction of

the torque link lug and upper case of the

main landing gear (MLG) torque link

assemblies for cracks on Pilatus BrittenNorman BN–2A, BN–2B, BN–2T, and

BN2A MK. 111 series airplanes, and

replacing any cracked part.

Pilatus Britten-Norman has developed

a modification that, when incorporated,

would eliminate the need for the

repetitive inspection requirement of AD

86–07–02 for the Pilatus Britten-Norman

BN–2A, BN–2B, and BN–2T series

airplanes. The requirements of AD 86–

07–02 should still apply for the Pilatus

Britten-Norman BN2A MK. 111 series

airplanes.

Applicable Service Information

Fairey Hydraulics Limited has issued

Service Bulletin (SB) 32–7, Issue 3,

dated January 30, 1990, and Fairey

Hydraulics Limited SB 32–10, Issue 2,

dated November 10, 1992. These SB’s

include procedures for inspecting the

junction of the torque link lug and

upper case of the MLG torque link

assemblies on Pilatus Britten-Norman

BN2A MK. 111 series airplanes. Pilatus

Britten-Norman SB BN–2/SB. 173, Issue

3, dated November 16, 1990, references

Fairey Hydraulic Limited SB 32–7; and

Pilatus Britten-Norman SB BN–2/

SB.209, Issue 1, datedNovember 30,

1992, references Fairey Hydraulic

Limited SB 32–10.
Federal Register / Vol. 62, No. 44 / Thursday, March 6, 1997 / Proposed Rules 10241

The FAA’s Determination

The FAA has examined all available

information related to this subject

matter and has determined that:

• AD 86–07–02 should be revised to

remove the BN–2A, BN–2B, and BN–2T

series airplanes from the applicability of

the AD (the BN2A MK. 111 series

airplanes should still apply); and

• separate AD action should be taken

for the Pilatus Britten-NormanBN–2A,

BN–2B, and BN–2T series airplanes to

require a modification to the main

landing gear torque link assembly.

Explanation of the Provisions of the

Proposed AD

Since an unsafe condition has been

identified that is likely to exist or

develop in other Pilatus Britten-Norman

BN2A MK. 111 series airplanes of the

same type design, the proposed AD

would revise AD 86–07–02 by removing

the BN–2A, BN–2B, and BN–2T series

airplanes from the applicability of that

AD. The requirement of repetitively

inspecting the junction of the torque

link lug and upper case of the MLG

torque link assemblies would be

retained for the BN2A MK. 111 series

airplanes. The FAA will propose

separate AD action for the BN–2A and

BN–2T series airplanes to require a

modification that, when incorporated,

would eliminate the repetitive

inspection requirement currently

required by AD 86–07–02.

Accomplishment of the proposed

inspections and would be accomplished

in accordance with the previously

referenced service bulletins.

Cost Impact

The FAA estimates that nine airplanes

in the U.S. registry would be affected by

the proposed AD, that it would take

approximately one workhour per

airplane to accomplish the proposed

initial inspection, and that the average

labor rate is approximately $60 an hour.

Based on these figures, the total cost

impact of the proposed AD on U.S.

operators is estimated to be $540 or $60

per airplane. This figure only takes into

account the cost of the proposed initial

inspection and does not take into

account the cost of the proposed

repetitive inspections. The FAA has no

way of determining the number of

repetitive inspections each of the

owners/operators would incur over the

life of the affected airplanes.

In addition, the proposed inspections

are currently required on the nine

affected airplanes. The proposed AD

would not require any additional

actions over that already required by AD

86–07–02.

Regulatory Impact

The regulations proposed herein

would not have substantial direct effects

on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government. Therefore,

in accordance with Executive Order

12612, it is determined that this

proposal would not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (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) if

promulgated, will not have a significant

economic impact, positive or negative,

on a substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A copy of the draft

regulatory evaluation prepared for this

action has been placed in the Rules

Docket. A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend part

39 of the Federal Aviation Regulations

(14 CFR part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

removing Airworthiness Directive (AD)

86–07–02, Amendment 39–5382, and by

adding a new AD to read as follows:

Pilatus Britten-Norman LTD.: Docket No. 86–

CE–23–AD. Revises AD 86–07–02,

Amendment 39–5382.

Applicability: Models MK. 111, BN2A MK.

111–2, and BN2A MK. 111–3 airplanes (all

serial numbers), certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (f) of this AD. The

request should include an assessment of the

effect of the modification, alteration, or repair

on the unsafe condition addressed by this

AD; and, if the unsafe condition has not been

eliminated, the request should include

specific proposed actions to address it.

Compliance: Required prior to further

flight after the effective date of this AD (see

Note 2) or within 100 hours time-in-service

(TIS) after the last inspection accomplished

in accordance with AD 86–07–02, whichever

occurs later, and thereafter at intervals not to

exceed100 hours TIS.

Note 2: The ‘‘prior to further flight after the

effective date of this AD’’ compliance time

was the original initial compliance time of

AD 86–07–02, and is being retained to

provide credit and continuity for alreadyaccomplished and future inspections.

To prevent failure of the main landing gear

caused by cracks in the torque link assembly

area, which could lead to loss of control of

the airplane during landing operations,

accomplish the following:

(a) Inspect the junction of the torque link

lug and upper case for cracks (using a 10-

power magnifying glass or by dye penetrant

methods) in accordance with Fairey

Hydraulics Limited Service Bulletin (SB) 32–

7, Issue 3, dated January 30, 1990, or Fairey

Hydraulics SB 32–10, Issue 2, dated

November 10, 1992, as applicable. Pilatus

Britten-Norman SB BN–2/SB. 173, Issue 3,

dated November 16, 1990, references Fairey

Hydraulic Limited SB 32–7; and Pilatus

Britten-Norman SB BN–2/SB.209, Issue 1,

dated November 30, 1992, references Fairey

Hydraulic Limited SB 32–10.

(b) If cracked parts are found during any

of the inspections required by this AD, prior

to further flight, replace the cracked parts

with airworthy parts in accordance with the

applicable maintenance manual.

(c) If the landing gear is replaced, only

equal pairs of the same manufacturer are

approved as replacement parts. Mixing of

different manufacturer landing gears is not

authorized.

(d) The intervals between the repetitive

inspections required by this AD may be

adjusted up to 10 percent of the specified

interval to allow accomplishing these actions

along with other scheduled maintenance on

the airplane.

(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 inspection requirements

of this AD can be accomplished.

(f) An alternative method of compliance or

adjustment of the initial or repetitive

compliance times that provides an equivalent

level of safety may be approved by the

Manager, Brussels Aircraft Certification

Division, Europe, Africa, Middle East office,

FAA, c/o American Embassy, 1000 Brussels,

Belgium. The request should be forwarded

through an appropriate FAA Maintenance

Inspector, who may add comments and then

send it to the Manager, Brussels Aircraft

Certification Division. Alternative methods of
10242 Federal Register / Vol. 62, No. 44 / Thursday, March 6, 1997 / Proposed Rules

compliance approved for AD 86–07–02 are

considered approved as alternative methods

of compliance for this AD.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Brussels Aircraft

Certification Division.

(g) All persons affected by this directive

may obtain copies of the documents referred

to herein upon request to Fairey Hydraulics

Limited, Claverham, Bristol, England; or

Pilatus Britten-Norman Limited, Bembridge,

Isle of Wight, United Kingdom PO35 5PR, as

applicable; or may examine these documents

at the FAA, Central Region, Office of the

Assistant Chief Counsel, Room 1558, 601 E.

12th Street, Kansas City, Missouri 64106.

(h) This amendment revises AD 86–07–02,

Amendment 39–5382.

Issued in Kansas City, Missouri, on

February 25, 1997.

Michael Gallagher,

Manager, Small Airplane Directorate, Aircraft

Certification Service.

[FR Doc. 97–5491 Filed 3–5–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. 97N–0023]

RIN 0910–AA99

Chlorofluorocarbon Propellants in

Self-Pressurized Containers;

Determinations That Uses Are No

Longer Essential; Request for

Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is seeking public

comment on the policy it is considering

for adoption on making and

implementing determinations that uses

of chlorofluorocarbons (CFC’s) currently

designated essential will no longer be

deemed essential under the Clean Air

Act due to the availability of safe and

effective medical product technology

that does not use CFC’s. Essential-use

products are exempt from FDA’s ban on

the use of CFC propellants in FDAregulated products and the

Environmental Protection Agency’s

(EPA’s) ban on the use of CFC’s in

pressurized dispensers. The agency is

taking this action because it is

responsible for determining which

products containing CFC’s or other

ozone-depleting substances are an

essential use under the Clean Air Act.

FDA is soliciting comments on this

policy to assist the agency in striking an

appropriate balance that will best

protect the public health, both by

ensuring the availability of an adequate

number of treatment alternatives and by

curtailing the release of ozone-depleting

substances.

DATES: Written comments by May 5,

1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Under § 2.125 (21 CFR 2.125), any

food, drug, device, or cosmetic in a selfpressurized container that contains a

CFC propellant for a nonessential use is

adulterated, or misbranded, or both,

under the Federal Food, Drug, and

Cosmetic Act. This prohibition is based

on scientific research indicating that

CFC’s reduce the amount of ozone in the

stratosphere and thereby increase the

amount of ultraviolet radiation reaching

the earth. An increase in ultraviolet

radiation will increase the incidence of

skin cancer, and produce other adverse

effects of unknown magnitude on

humans, animals, and plants. Section

2.125(d) exempts from the adulteration

and misbranding provisions of

§ 2.125(c) certain products containing

CFC propellants that FDA determines

provide unique health benefits that

would not be available without the use

of a CFC.

These products are referred to in the

regulation as essential uses of CFC’s and

are listed in § 2.125(e). Under § 2.125(f),

any person may petition FDA to request

additions to the list of uses considered

essential. To demonstrate that the use of

a CFC is essential, the petition must be

supported by an adequate showing that:

(1) There are no technically feasible

alternatives to the use of a CFC in the

product; (2) the product provides a

substantial health, environmental, or

other public benefit that would not be

obtainable without the use of the CFC;

and (3) the use does not involve a

significant release of CFC’s into the

atmosphere or, if it does, the release is

warranted by the consequence if the use

were not permitted.

EPA regulations implementing the

provisions of section 610 of the Clean

Air Act (42 U.S.C. 7671i) contain a

general ban on the use of CFC’s in

pressurized dispensers, such as

metered-dose inhalers (MDI’s) (40 CFR

82.64(c) and 82.66(d)). These EPA

regulations exempt from the general ban

‘‘medical devices’’ that FDA considers

essential and that are listed in

§ 2.125(e). Section 601(8) of the Clean

Air Act (42 U.S.C. 7671(8)) defines

‘‘medical device’’ as any device (as

defined in the Federal Food, Drug, and

Cosmetic Act), diagnostic product, drug

(as defined in the Federal Food, Drug,

and Cosmetic Act), and drug delivery

system, if such device, product, drug, or

drug delivery system uses a class I or

class II ozone-depleting substance for

which no safe and effective alternative

has been developed (and, where

necessary, approved by the

Commissioner of Food and Drugs (the

Commissioner)); and if such device,

product, drug, or drug delivery system

has, after notice and opportunity for

public comment, been approved and

determined to be essential by the

Commissioner in consultation with the

Administrator of EPA (the

Administrator). Class I substances

include CFC’s, halons, carbon

tetrachloride, methyl chloroform,

methyl bromide, and other chemicals

not relevant to this document (see 40

CFR part 82, appendix A to subpart A).

Class II substances include

hydrochlorofluorocarbons (HCFC’s) (see

40 CFR part 82, appendix B to subpart

A).

Production of ozone-depleting

substances is being phased out

worldwide under the terms of the

Montreal Protocol on Substances that

Deplete the Ozone Layer (Montreal

Protocol), Sept. 16, 1987, S. Treaty Doc.

No. 10, 100th Cong., 1st sess., 26 I.L.M.

1541 (1987). In accordance with the

provisions of the Montreal Protocol,

under authority of Title VI of the Clean

Air Act (section 601 et seq.),

manufacture of CFC’s in the United

States was generally banned as of

January 1, 1996. To receive permission

to manufacture CFC’s in the United

States after the phaseout date,

manufacturers must obtain an

exemption from the phaseout

requirements from the Parties to the

Montreal Protocol. Procedures for

securing an essential-use exemption

under the Montreal Protocol are

described in the most recent request by

EPA for applications for exemptions (60

FR 54349, October 23, 1995). Firms that

wish to use CFC’s manufactured after

the phaseout date in medical devices (as