65148 Federal Register / Vol. 77, No. 207 / Thursday, October 25, 2012 / Proposed Rules 

the relevant information in the general 

revisions is identical to that in Airbus 

Temporary Revision TR37, Issue 1.0, dated 

June 15, 2010; or Airbus Temporary Revision 

TR38, Issue 1.0, dated June 15, 2010. 

(h) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the International Branch, send it to ATTN: 

Vladimir Ulyanov, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA 1601 Lind Avenue 

SW., Renton, Washington 98057–3356; 

telephone (425) 227–1138; fax (425) 227– 

1149. Information may be emailed to: 9– 

ANM–116–AMOC–REQUESTS@faa.gov. 

Before using any approved AMOC, notify 

your appropriate principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office/ 

certificate holding district office. The AMOC 

approval letter must specifically reference 

this AD. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(i) Related Information 

(1) Refer to MCAI European Aviation 

Safety Agency Airworthiness Directive 2012– 

0069, dated April 24, 2012, and the service 

information specified in paragraphs (i)(1)(i) 

and (i)(1)(ii) of this AD, for related 

information. 

(i) Airbus Temporary Revision TR37, Issue 

1.0, dated June 15, 2010. 

(ii) Airbus Temporary Revision TR38, Issue 

1.0, dated June 15, 2010. 

(2) For service information identified in 

this AD, contact Airbus SAS—Airworthiness 

Office—EAL, 1 Rond Point Maurice Bellonte, 

31707 Blagnac Cedex, France; telephone +33 

5 61 93 36 96; fax +33 5 61 93 45 80; email 

airworthiness.A330-A340@airbus.com; 

Internet http://www.airbus.com. You may 

review copies of the referenced service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue SW., Renton, 

WA. For information on the availability of 

this material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on October 

14, 2012. 

John P. Piccola, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2012–26264 Filed 10–24–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2012–1107; Directorate 

Identifier 2011–NM–216–AD] 

RIN 2120–AA64 

Airworthiness Directives; 

Intertechnique Aircraft Systems 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) that 

applies to certain Intertechnique 

Aircraft Systems oxygen mask 

regulators. This proposed AD was 

prompted by a report of a 

malfunctioning mask having an 

inflatable harness with a high premature 

rupture rate due to defective silicon. 

This proposed AD would require 

inspecting and replacing defective 

harnesses with new or modified 

serviceable units. We are proposing this 

AD to detect and correct defective 

harnesses which could lead, in case of 

a sudden depressurization event, to a 

harness rupture, thereby providing 

inadequate protection against hypoxia 

and possibly resulting in 

unconsciousness of the affected 

flightcrew member and consequent 

reduced control of the airplane. 

DATES: We must receive comments on 

this proposed AD by December 10, 

2012. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: (202) 493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this proposed AD, contact 

Intertechnique Aircraft Systems, 61 Rue 

Pierre Curie BP 1, 78373 Plaisir Cedex— 

France; telephone: (33) 1 61 34 12 32; 

fax: (33) 1 64 86 69 84; email: 

yann.laine@zodiacaerospace.com; 

Internet: www.zodiacaerospace.com. 

You may review copies of the 

referenced service information at the 

FAA, Transport Airplane Directorate, 

1601 Lind Avenue SW., Renton, 

Washington. For information on the 

availability of this material at the FAA, 

call 425–227–1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Operations office between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Operations 

office (telephone (800) 647–5527) is in 

the ADDRESSES section. Comments will 

be available in the AD docket shortly 

after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Caspar Wang, Aerospace Engineer, 

Boston Aircraft Certification Office 

(ACO) ANE–150, FAA, Engine and 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

phone: (781) 238–7799; fax: (781) 238– 

7170; email: caspar.wang@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2012–1107; Directorate Identifier 

2011–NM–216–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD based on those comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

The European Aviation Safety Agency 

(EASA), which is the Technical Agent 

for the Member States of the European 

Community, has issued EASA 

Airworthiness Directive 2011–0090R1, 

dated July 13, 2011 (referred to after this 

as ‘‘the MCAI’’), to correct an unsafe 

condition for the specified products. 

The MCAI states: 

A malfunction of a quick donning mask 

was reported to Intertechnique, who initiated 


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Federal Register / Vol. 77, No. 207 / Thursday, October 25, 2012 / Proposed Rules 65149 

an investigation in order to detect the root 

cause and the failure mode. Despite the fact 

that the analysis did not lead to any final 

conclusion, discrete suspected silicon 

batches have been identified which have 

shown an unusually high premature rupture 

rate. 

Some of the affected harnesses are known 

to have been delivered as spares. 

Consequently, an inflatable harness 

belonging to one of the suspect batches may 

have become installed on an Oxygen Mask 

Regulator, the serial number (s/n) or [part 

number] P/N of which is not identified in 

Appendix II of Intertechnique Service 

Bulletin (SB) MXH–35–240. 

This fact widens the Applicability of this 

[EASA] AD to extend beyond the individual 

Oxygen Mask Regulators identified by s/n 

and P/N in Appendix II of the SB. 

This condition, if not detected and 

corrected, could lead, in case of a sudden 

depressurization event, to a harness rupture, 

thereby providing inadequate protection 

against hypoxia of the affected flight crew 

member, possibly resulting in 

unconsciousness and consequent reduced 

control of the aeroplane. 

For the reasons described above, this 

[EASA] AD requires the identification and 

replacement of all potentially defective 

harnesses with serviceable units. 

Note 1: The affected batches were installed 

on harnesses manufactured between 

December 2008 and August 2010, having 

dates codes 0850S (week 50 of 2008) through 

1031S (week 31 of 2010). 

Note 2: Harness assemblies that do not 

have a batch code were manufactured before 

week 33 of 2008 and are not affected by this 

unsafe condition. 

This [EASA] AD has been revised to 

correct a typographical error in the 

Applicability, which inadvertently referred 

to P/N MA10–12 masks, whereas in fact, all 

P/N MA10 series could have an affected 

harness installed. In addition, this revised 

AD corrects Note 2 (above), which confused 

harness manufacturing date codes with the 

affected harnesses batch codes. 

This [EASA] AD is also revised to make 

reference to the latest revisions of the 

referenced Intertechnique service 

publications which identify by s/n and P/N, 

in Appendix II of the SB, more oxygen mask 

regulators that are known or suspected to 

have an affected harness installed. Finally, 

this AD is revised to add a Note to the 

Required Actions section, to stress the fact 

that other oxygen mask regulators could be 

affected, in addition to those listed in 

Appendix II of the SB. 

You may obtain further information 

by examining the MCAI in the AD 

docket. 

Relevant Service Information 

Zodiac Aerospace Intertechnique has 

issued the following service bulletins: 

• Intertechnique Service Bulletin 

MXH–35–240, Revision 7, dated 

September 1, 2011 (for all airplanes 

other than Bombardier airplanes). 

• Intertechnique Service Bulletin 

MXH–35–241, Revision 2, dated May 

19, 2011 (for Bombardier airplanes). 

The actions described in this service 

information are intended to correct the 

unsafe condition identified in the 

MCAI. 

FAA’s Determination and Requirements 

of This Proposed AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to our 

bilateral agreement with the State of 

Design Authority, we have been notified 

of the unsafe condition described in the 

MCAI and service information 

referenced above. We are proposing this 

AD because we evaluated all pertinent 

information and determined an unsafe 

condition exists and is likely to exist or 

develop on other products of the same 

type design. 

Costs of Compliance 

Based on the service information, we 

estimate that this proposed AD would 

affect up to 5,500 products of U.S. 

registry. We also estimate that it would 

take about 1 work-hour per product to 

comply with the basic requirements of 

this proposed AD. The average labor 

rate is $85 per work-hour. Required 

parts would cost about $0 per product. 

Where the service information lists 

required parts costs that are covered 

under warranty, we have assumed that 

there will be no charge for these parts. 

As we do not control warranty coverage 

for affected parties, some parties may 

incur costs higher than estimated here. 

Based on these figures, we estimate the 

cost of the proposed AD on U.S. 

operators up to $467,500, or $85 per 

product. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect 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. 

For the reasons discussed above, I 

certify this proposed regulation: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); 

3. Will not affect intrastate aviation in 

Alaska; and 

4. 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. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this proposed AD and placed it in the 

AD docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 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. The FAA amends § 39.13 by adding 

the following new AD: 

Intertechnique Aircraft Systems: Docket No. 

FAA–2012–1107; Directorate Identifier 

2011–NM–216–AD. 

(a) Comments Due Date 

We must receive comments by December 

10, 2012. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Intertechnique Aircraft 

Systems flight crew oxygen mask regulators, 

all part number (P/N) MA10, MC10, MC20, 

MF10, MF20, MLC20, MLD20, MRA005, 

MRA022, and MRA023 series; certificated in 


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65150 Federal Register / Vol. 77, No. 207 / Thursday, October 25, 2012 / Proposed Rules 

any category; installed on, but not limited to, 

airplanes manufactured by Airbus, ATR, BAE 

Systems (Type Certificate previously held by 

British Aerospace), Boeing, Bombardier 

(Type Certificate previously held by 

Canadair, De Havilland Canada), Cessna, 

Dassault, EADS CASA, EMBRAER, 

Gulfstream, Hawker Beechcraft (Type 

Certificate previously held by Raytheon, 

Beech), Israel Aircraft Industries (IAI), 

McDonnell Douglas, Piaggio, Pilatus, Piper 

and SOCATA. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 35: Oxygen. 

(e) Reason 

This AD was prompted by a report of a 

malfunctioning mask having an inflatable 

harness with a high premature rupture rate 

due to defective silicon. We are issuing this 

AD to detect and correct defective harnesses 

which could lead, in case of a sudden 

depressurization event, to a harness rupture, 

thereby providing inadequate protection 

against hypoxia and possibly resulting in 

unconsciousness of the affected flightcrew 

member and consequent reduced control of 

the airplane. 

(f) Compliance 

You are responsible for having the actions 

required by this AD performed within the 

compliance times specified, unless the 

actions have already been done. 

(g) Inspection 

(1) Except as provided by paragraph (i) of 

this AD: Within 24 months after the effective 

date of this AD, inspect the inflatable harness 

fitted to each flight crew oxygen mask 

regulator to determine if the inflatable 

harness is installed with a part number (P/N) 

and a batch number identified in Appendix 

I of Intertechnique Service Bulletin MXH– 

35–240, Revision 7, dated September 1, 2011 

(for all airplanes other than Bombardier 

airplanes); or Appendix I of Intertechnique 

Service Bulletin MXH–35–241, Revision 2, 

dated May 19, 2011 (for Bombardier 

airplanes). 

(2) Referring only to Appendix II of 

Intertechnique Service Bulletin MXH–35– 

240, Revision 7, dated September 1, 2011 (for 

all airplanes other than Bombardier 

airplanes); or Appendix II of Intertechnique 

Service Bulletin MXH–35–241, Revision 2, 

dated May 19, 2011 (for Bombardier 

airplanes); to identify a specific oxygen mask 

regulator is insufficient to demonstrate that 

the inflatable harness fitted to that oxygen 

mask regulator is not listed in Appendix I of 

Intertechnique Service Bulletin MXH–35– 

240, Revision 7, dated September 1, 2011; or 

Appendix I of Intertechnique Service 

Bulletin MXH–35–241, Revision 2, dated 

May 19, 2011. 

(h) Replacement 

If during the inspection required by 

paragraph (g)(1) of this AD, an inflatable 

harness has a part number and batch number 

identified in Appendix I of Intertechnique 

Service Bulletin MXH–35–240, Revision 7, 

dated September 1, 2011 (for all airplanes 

other than Bombardier airplanes); or 

Appendix I of Intertechnique Service 

Bulletin MXH–35–241, Revision 2, dated 

May 19, 2011 (for Bombardier airplanes): 

Before further flight, replace the inflatable 

harness with a new or re-identified harness, 

in accordance with the Accomplishment 

Instructions of Intertechnique Service 

Bulletin MXH–35–240, Revision 7, dated 

September 1, 2011 (for all airplanes other 

than Bombardier airplanes); or 

Intertechnique Service Bulletin MXH–35– 

241, Revision 2, dated May 19, 2011 (for 

Bombardier airplanes). 

(i) Exception 

Oxygen mask regulators having a date of 

manufacturing (DMF) code of November 

2008 (112008 or 11–08) or earlier, and those 

with a DMF of January 2011 (012011 or 01– 

11) or later, are excluded from the inspection 

and replacement requirements of paragraphs 

(g) and (h) of this AD, provided it can be 

demonstrated that the inflatable harness has 

not been replaced on those masks. A review 

of airplane delivery or maintenance records 

is acceptable to make the determination as 

specified in this paragraph if the part 

number, batch number, and DMF can be 

conclusively determined from that review. 

(j) Definition 

For the purpose of this AD, Bombardier 

airplanes include airplanes previously 

manufactured by Canadair or by De 

Havilland Canada. 

(k) Parts Installation Prohibition 

As of the effective date of this AD, no 

person may install a flight crew oxygen mask 

regulator having a part number and batch 

number on the inflatable harness that is 

found in Appendix I of Intertechnique 

Service Bulletin MXH–35–240, Revision 7, 

dated September 1, 2011 (for all airplanes 

other than Bombardier airplanes); or 

Intertechnique Service Bulletin MXH–35– 

241, Revision 2, dated May 19, 2011 (for 

Bombardier airplanes) on any airplane. 

(l) Credit for Previous Actions 

This paragraph provides credit for actions 

required by paragraph (g) of this AD, if those 

actions were performed before the effective 

date of this AD using a service bulletin 

specified in paragraph (l)(1), (l)(2), or (l)(3) of 

this AD: 

(1) Intertechnique Service Bulletin MXH– 

35–240, Revision 6, dated August 16, 2011. 

(2) Intertechnique Service Bulletin MXH– 

35–240, Revision 5, dated July 26, 2011. 

(3) Intertechnique Service Bulletin MXH– 

35–240, Revision 4, dated June 10, 2011. 

(m) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Boston Aircraft 

Certification Office (ACO) ANE–150, FAA, 

has the authority to approve AMOCs for this 

AD, if requested using the procedures found 

in 14 CFR 39.19. In accordance with 14 CFR 

39.19, send your request to your principal 

inspector or local Flight Standards District 

Office, as appropriate. If sending information 

directly to the ACO, send it to ATTN: Caspar 

Wang, Aerospace Engineer, Boston Aircraft 

Certification Office (ACO) ANE–150, FAA, 

Engine and Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; phone: (781) 238–7799; fax: (781) 

238–7170. Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. The AMOC 

approval letter must specifically reference 

this AD. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(n) Related Information 

(1) Refer to MCAI EASA Airworthiness 

Directive 2011–0090R1, dated July 13, 2011, 

and the service information specified in 

paragraphs (n)(1)(i) and (n)(1)(ii) of this AD, 

for related information. 

(i) Intertechnique Service Bulletin MXH– 

35–240, Revision 7, dated September 1, 2011. 

(ii) Intertechnique Service Bulletin MXH– 

35–241, Revision 2, dated May 19, 2011. 

(2) For service information identified in 

this AD, contact Intertechnique Aircraft 

Systems, 61 Rue Pierre Curie BP 1, 78373 

Plaisir Cedex—France; telephone: (33) 1 61 

34 12 32; fax: (33) 1 64 86 69 84; email: 

yann.laine@zodiacaerospace.com; Internet: 

www.zodiacaerospace.com. You may review 

copies of the referenced service information 

at the FAA, Transport Airplane Directorate, 

1601 Lind Avenue SW., Renton, Washington. 

For information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on October 

15, 2012. 

John P. Piccola, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2012–26266 Filed 10–24–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2004–C–0559 (Formerly 

Docket No. 2004C-0078)] 

Cryovac North America; Withdrawal of 

Color Additive Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal, without prejudice to a 

future filing, of a color additive petition 

(CAP 4C0276) proposing that the color 


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