Federal Register / Vol. 70, No. 175 / Monday, September 12, 2005 / Rules and Regulations 53725 

tend to effectuate the declared policy of 

the Act. 

Pursuant to 5 U.S.C. 553, it is also 

found and determined upon good cause 

that it is impracticable, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect and that good cause 

exist for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) Any changes resulting from 

this rule should be effective as soon as 

practicable because the Washington 

potato shipping season began in July; (2) 

the Committee unanimously 

recommended these changes at a public 

meeting and all interested parties had 

an opportunity to provide input; (3) 

handlers are aware of this action and 

want to take advantage of this relaxation 

as soon as possible; and (4) this rule 

provides a 60-day comment period and 

any comments received will be 

considered prior to finalization of this 

rule. 

List of Subjects in 7 CFR Part 946 

Marketing agreements, Potatoes, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, 7 CFR part 946 is amended as 

follows: 

PART 946—IRISH POTATOES GROWN 

IN WASHINGTON 

■ 1. The authority citation for 7 CFR 

part 946 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. In § 946.336, paragraph (c)(1) is 

revised to read as follows: 

§ 946.336 Handling regulation. 

* * * * * 

(c) Pack and marking: 

(1) Domestic: Potatoes packed in 

cartons shall be either: 

(i) U.S. No. 1 grade or better, except 

that potatoes which fail to meet the U.S. 

No. 1 grade only because of internal 

defects may be shipped without regard 

to this requirement provided the lot 

contains no more than 10 percent 

damage by any internal defect or 

combination of internal defects but not 

more than 5 percent serious damage by 

any internal defect or combination of 

internal defects. 

(ii) U.S. No. 2 grade, provided the 

cartons are permanently and 

conspicuously marked as to grade. This 

marking requirement does not apply to 

cartons containing potatoes meeting the 

requirements of (c)(1)(i). 

* * * * * 

Dated: September 6, 2005. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 05–17964 Filed 9–9–05; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. 2001–NE–17–AD; Amendment 

39–14265; AD 2005–01–15R1] 

RIN 2120–AA64 

Airworthiness Directives; Rolls-Royce 

plc RB211 Trent 875, 877, 884, 884B, 

892, 892B, and 895 Series Turbofan 

Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: The FAA is revising an 

existing airworthiness directive (AD) for 

Rolls-Royce plc (RR) RB211 Trent 875, 

877, 884, 884B, 892, 892B, and 895 

series turbofan engines with certain part 

number (P/N) low pressure compressor 

(LPC) fan blades installed. That AD 

currently requires initial and repetitive 

ultrasonic inspections of the fan blade 

dovetail roots and defines a specific 

terminating action to the repetitive 

blade inspection requirements. This AD 

requires the same actions but clarifies 

the terminating action. We are issuing 

this AD to prevent multiple LPC fan 

blade failures due to cracks, which 

could result in uncontained engine 

failure and possible damage to the 

airplane. 

DATES: This AD becomes effective 

October 17, 2005. The Director of the 

Federal Register previously approved 

the incorporation by reference of certain 

publications listed in the regulations as 

of January 28, 2005 (70 FR 2336, January 

13, 2005). 

ADDRESSES: Contact Rolls-Royce plc, 

P.O. Box 31, Derby DE24 6BJ, UK; 

telephone 44 (0) 1332 242424; fax 44 (0) 

1332 249936, for the service information 

identified in this AD. 

You may examine the AD docket at 

the FAA, New England Region, Office of 

the Regional Counsel, 12 New England 

Executive Park, Burlington, MA. You 

may examine the service information, at 

the FAA, New England Region, Office of 

the Regional Counsel, 12 New England 

Executive Park, Burlington, MA. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Spinney, Aerospace 

Engineer, Engine Certification Office, 

FAA, Engine and Propeller Directorate, 

12 New England Executive Park, 

Burlington, MA 01803–5299; telephone 

(781) 238–7175; fax (781) 238–7199. 

SUPPLEMENTARY INFORMATION: On 

January 3, 2005, we issued AD 2005–

01–15, Amendment 39–13940 (70 FR 

2336, January 13, 2005). That AD 

superseded AD 2002–11–08, 

Amendment 39–12769 (67 FR 38852 

June 6, 2002). AD 2005–01–15 requires 

initial and repetitive ultrasonic 

inspections of the fan blade dovetail 

roots, and defines a specific terminating 

action to the repetitive blade inspection 

requirements. That AD was the result of 

a report of a cracked fan blade found 

before the blade reached the initial 

inspection threshold of AD 2002–11–08. 

That AD also reduced the repetitive 

inspection compliance time due to 

potential breakdown of blade coating 

and lubrication on certain blades. Those 

conditions, if not corrected, could result 

in uncontained engine failure and 

possible damage to the airplane. 

Actions Since We Issued AD 2005–01– 

15 

Since we issued AD 2005–01–15, we 

received a comment from an operator 

requesting that we clarify the 

terminating action in that AD. As that 

AD is currently written, you must install 

LPC fan blades in complete sets to 

comply with the terminating action. Our 

intent is that all blades must be replaced 

with blades that meet the replacement 

criteria to qualify as terminating action, 

but not necessarily replaced as a 

complete set. In response to the 

comment, we published a proposed AD 

in the Federal Register on March 9, 

2005 (70 FR 11585). That action 

proposed to require initial and 

repetitive ultrasonic inspections of the 

fan blade dovetail roots, and to clarify 

a specific terminating action to the 

repetitive blade inspection 

requirements. 

Examining the AD Docket 

You may examine the AD Docket 

(including any comments and service 

information), by appointment, between 

8 a.m. and 4:30 p.m., Monday through 

Friday, except Federal holidays. See 

ADDRESSES for the location. 

Comments 

We provided the public the 

opportunity to participate in the 

development of this AD. We received no 

comments on the proposal or on the 

determination of the cost to the public. 

53726 Federal Register / Vol. 70, No. 175 / Monday, September 12, 2005 / Rules and Regulations 

Conclusion 

We have carefully reviewed the 

available data and determined that air 

safety and the public interest require 

adopting the AD as proposed. 

Costs of Compliance 

There are about 350 RR RB211 Trent 

875, 877, 884, 884B, 892, 892B, and 895 

series turbofan engines of the affected 

design in the worldwide fleet. We 

estimate that 90 engines installed on 

airplanes of U.S. registry will be affected 

by this AD. We also estimate that it 

would take about 8 work hours per 

engine to perform the inspections, and 

about 260 work hours per engine to 

perform the terminating action. The 

average labor rate is $65 per work hour. 

Based on these figures, we estimate the 

total cost of the AD to U.S. operators to 

be $1,567,800. 

Regulatory Findings 

We have determined that this AD will 

not have federalism implications under 

Executive Order 13132. This AD will 

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 that this AD: 

(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) 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 summary of the costs 

to comply with this AD and placed it in 

the AD Docket. You may get a copy of 

this summary by sending a request to us 

at the address listed under ADDRESSES. 

Include ‘‘AD Docket No. 2001–NE–17–

AD’’ in your request. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the Federal Aviation Administration 

amends 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 

removing Amendment 39–13940 (70 FR 

2336, January 13, 2005), and by adding 

the following new airworthiness 

directive, Amendment 39–14265: 

2005–01–15R1 Rolls-Royce plc: 

Amendment 39–14265. Docket No. 

2001–NE–17–AD. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective October 17, 2005. 

Affected ADs 

(b) This AD revises AD 2005–01–15, 

Amendment 39–13940. 

Applicability: (c) This AD applies to RollsRoyce plc (RR) RB211 Trent 875, 877, 884, 

884B, 892, 892B, and 895 series turbofan 

engines with low pressure compressor (LPC) 

fan blades, part numbers (P/Ns) FK30838, 

FK30840, FK30842, FW12960, FW12961, 

FW12962, and FW13175, installed. These 

engines are installed on, but not limited to, 

Boeing Company 777 series airplanes. 

Unsafe Condition 

(d) This AD revision results from a request 

by an operator to clarify the terminating 

action in AD 2005–01–15. We are issuing this 

AD to prevent multiple LPC fan blade 

failures due to cracks, which could result in 

uncontained engine failure and possible 

damage to the airplane. 

Compliance: (e) You are responsible for 

having the actions required by this AD 

performed within the compliance times 

specified unless the actions have already 

been done. 

(f) Ultrasonic-inspect and disposition the 

dovetail roots of LPC fan blades, P/Ns 

FK30838, FK30840, FK30842, FW12960, 

FW12961, FW12962, and FW13175, that are 

removed from the engine, using 3.A.(1) 

through 3.A.(5) or, for blades that are not 

removed from the engine, using 3.B.(1) 

through 3.B.(5) of the Accomplishment 

Instructions of RR Alert Service Bulletin 

(ASB) No. RB.211–72–AD344, Revision 7, 

dated March 12, 2004, as follows: 

(1) For blades P/Ns FK30838, FK30840, 

and FK30842, that have not been relubricated 

during any interval exceeding 600 cyclessince-new (CSN) or 600 cycles-since-rework 

(CSR) using either RR ASB No. RB.211–72–

AD344 or Service Bulletin (SB) No. RB.211–

72–D347, inspect as specified in paragraph (f) 

of this AD and within the compliance times 

specified in the following Table 1: 

TABLE 1.—COMPLIANCE TIMES FOR BLADES P/NS FK30838, FK30840, AND FK30842 

Engine series Boeing 777 

series 

Airplane maximum gross weight 

(times 1,000 pounds) 

Initial 

inspection 

CSN 

Repetitive 

inspection 

(cycles-sincelast-inspection) 

(CSLI) 

(i) –884B, –892 ............................................... –300 (A) 660 and 632.5 .......................................... 600 80 

(B) 580 ........................................................... 2,000 600 

(ii) –884, 884, –892, –892B, and –895 ........... –200 (A) 632.5 and 648 .......................................... 1,200 100 

(B) 656 ........................................................... 600 80 

(C) 555 ........................................................... 2,000 600 

(iii) –875 .......................................................... –200 535 ................................................................. 2,000 600 

(iv) –877 .......................................................... –200 545 ................................................................. 2,000 600 

(2) For blades P/Ns FK30838, FK30840, 

and FK30842, that have been relubricated at 

intervals not exceeding 600 CSN or 600 CSR 

using either RR ASB No. RB.211–72–AD344 

or SB No. RB.211–72–D347, inspect as 

specified in paragraph (f) of this AD and 

within the compliance times specified in the 

following Table 2: 

TABLE 2.—COMPLIANCE TIMES FOR BLADES P/NS FK30838, FK30840, AND FK30842 

Engine series Boeing 777 

series 

Airplane maximum gross weight 

(times 1,000 pounds) 

Initial inspection 

CSN 

Repetitive inspection 

CSLI 

(i) –884B, 892 ................................................. –300 (A) 660 and 632.5 .......................................... 600 80 

Federal Register / Vol. 70, No. 175 / Monday, September 12, 2005 / Rules and Regulations 53727 

TABLE 2.—COMPLIANCE TIMES FOR BLADES P/NS FK30838, FK30840, AND FK30842—Continued 

Engine series Boeing 777 

series 

Airplane maximum gross weight 

(times 1,000 pounds) 

Initial inspection 

CSN 

Repetitive inspection 

CSLI 

(B) 580 ........................................................... 2,400 600 

(ii) –884, –892, –892B, and –895 ................... –200 (A) 632.5 and 648 .......................................... 1,200 100 

(B) 656 ........................................................... 600 80 

(C) 555 ........................................................... 2,400 600 

(iii) –875 .......................................................... –200 535 ................................................................. 2,400 600 

(iv) –877 .......................................................... –200 545 ................................................................. 2,400 600 

(3) For blades P/Ns FW12960, FW12961, 

FW12962, and FW13175, either new or 

reworked to that configuration at greater than 

600 CSN or since previous rework, or that 

have not been relubricated during any 

interval exceeding 600 CSN or 600 CSR using 

either RR ASB No. RB.211–72–AD344 or SB 

No. RB.211–72–D347 requirements, inspect 

as specified in paragraph (f) of this AD and 

within the compliance times specified in the 

following 

TABLE 3.—COMPLIANCE TIMES FOR BLADES P/NS FW12960, FW12961, FW12962, AND FW13175 

Engine series Boeing 777 

series 

Airplane maximum gross weight 

(times 1,000 pounds) 

Initial 

inspection 

CSN 

Repetitive 

inspection 

CSLI 

(i) –884B, –892 ............................................... –300 (A) 660 and 632.5 .......................................... 600 100 

(B) 580 ........................................................... 2,000 600 

(ii) –884B, –892, –892B, and –895 ................ –200 (A) 632.5 and 648 .......................................... 1,200 125 

(B) 656 ........................................................... 600 100 

(C) 555 ........................................................... 2,000 600 

(iii) –875 .......................................................... –200 535 ................................................................. 2,000 600 

(iii) –877 .......................................................... –200 545 ................................................................. 2,000 600 

(4) For blades P/Ns FW12960, FW12961, 

FW12962, and FW13175, either new or 

reworked to that configuration at fewer than 

600 CSN or since previous rework, and that 

have been relubricated at intervals not 

exceeding 600 CSN using either RR ASB No. 

RB.211–72–AD344 or SB No. RB.211–72–

D347, inspect as specified in paragraph (f) of 

this AD and within the compliance times 

specified in the following Table 4: 

TABLE 4.—COMPLIANCE TIMES FOR BLADES P/NS FW12960, FW12961, FW12962, AND FW13175 

Engine series Boeing 777 

series 

Airplane maximum gross weight 

(times 1,000 pounds) 

Initial 

inspection 

CSN 

Repetitive 

inspection 

CSLI 

(i) –884B,–892 ................................................ –300 (A) 660 and 632.5 .......................................... 600 100 

(B) 580 ........................................................... 2,400 1,200 

(ii) –884,–892,–892B, and–895 ...................... –200 (A) 632.5 and 648 .......................................... 2,400 125 

(B) 656 ........................................................... 600 100 

(C) 555 ........................................................... 2,400 1,200 

(iii) –875 .......................................................... –200 535 ................................................................. 2,400 1,200 

(iv) –877 .......................................................... –200 545 ................................................................. 2,400 600 

(g) When engines containing blades P/Ns 

FK30838, FK30840, FK30842, FW12960, 

FW12961, FW12962, and FW13175 are 

moved from one gross weight category to 

another, the inspection schedule that is 

applicable to the higher gross weight category 

must be used. 

Terminating Action 

(h) As terminating action to the repetitive 

inspection requirements of this AD, at the 

next shop visit when the LPC fan blades are 

removed for repair or overhaul, but no later 

than December 31, 2009: 

(1) Replace LPC fan blades P/Ns FK30838, 

FK30840, FK30842, FW12960, FW12961, 

FW12962, or FW13175, with serviceable LPC 

fan blades. 

(2) For the purposes of this AD, serviceable 

LPC fan blades are blades that feature 

additional blade root processing 

requirements found in RR SB No. RB.211–

72–D672, dated February 1, 2002; or are LPC 

fan blades that feature a full form root profile. 

Information on full form root profile blades 

can be found in RR SB No. RB.211–72–D390, 

RR SB No. RB.211–72–E044, and RR SB No. 

RB.211–72–E382. 

Previous Credit 

(i) Previous credit is allowed for initial 

inspections of fan blades that were done 

using RR ASB No. RB.211–72–AD344, 

Revision 4, dated March 15, 2002, Revision 

5, dated June 20, 2003, Revision 6, dated 

February 27, 2004, or Revision 7, dated 

March 12, 2004, before the effective date of 

this AD. 

Alternative Methods of Compliance 

(j) The Manager, Engine Certification 

Office, has the authority to approve 

alternative methods of compliance for this 

AD if requested using the procedures found 

in 14 CFR 39.19. 

Material Incorporated by Reference 

(k) You must use the Rolls-Royce plc 

service information specified in Table 5 of 

this AD to perform the blade inspections and 

replacements required by this AD. The 

Director of the Federal Register approved the 

incorporation by reference of the documents 

listed in Table 5 of this AD as of January 28, 

2005 (70 FR 2336, January 13, 2005). You can 

get a copy from Rolls-Royce plc, P.O. Box 31, 

Derby DE24 6BJ, UK; telephone 44 (0) 1332 

242424; fax 44 (0) 1332 249936. You may 

review copies at the FAA, New England 

Region, Office of the Regional Counsel, 

Attention: Rules Docket No. 2001–NE–17–

AD, 12 New England Executive Park, 

Burlington, MA; or at the National Archives 

53728 Federal Register / Vol. 70, No. 175 / Monday, September 12, 2005 / Rules and Regulations 

and Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, or go 

to: http://www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Table 5 follows: 

TABLE 5.—INCORPORATION BY REFERENCE

Service Bulletin No. Page Revision Date 

RB.211–72–AD344 ............................................................. All ........................................ 7 .......................................... March 12, 2004. 

Total Pages: 11 

RB.211–72–AD344, Appendices 1 through 5 .................... All ........................................ 7 .......................................... March 12, 2004. 

Total Pages: 18 

RB.211–72–D672 ............................................................... All ........................................ Original ................................ February 1, 2002. 

Total Pages: 24 

Related Information 

(l) Civil Aviation Authority (CAA) 

airworthiness directive G–2004–0008, dated 

April 29, 2004, also addresses the subject of 

this AD. 

Issued in Burlington, Massachusetts, on 

September 6, 2005. 

Peter A. White, 

Acting Manager, Engine and Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. 05–17976 Filed 9–9–05; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. 2005D–0356] 

Guidance for Industry: Questions and 

Answers Regarding the Final Rule on 

Establishment and Maintenance of 

Records; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability of 

guidance. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Questions and Answers 

Regarding Establishment and 

Maintenance of Records.’’ The guidance 

responds to various questions raised 

about the recordkeeping provisions of 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) and the agency’s implementing 

regulation, which requires the 

establishment and maintenance of 

records by persons who manufacture, 

process, pack, transport, distribute, 

receive, hold, or import food in the 

United States. Such records are to allow 

for the identification of the immediate 

previous sources and the immediate 

subsequent recipients of food. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records’’ to Denise Beavers (see FOR

FURTHER INFORMATION CONTACT). Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Denise Beavers, Center for Food Safety 

and Applied Nutrition (HFS–24), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1721. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 9, 

2004 (69 FR 71562), FDA issued a final 

rule to implement section 306 of the 

Bioterrorism Act (21 U.S.C. 350c). The 

regulation requires the establishment 

and maintenance of records by persons 

who manufacture, process, pack, 

transport, distribute, receive, hold, or 

import food in the United States. Such 

records are to allow for the 

identification of the immediate previous 

sources and the immediate subsequent 

recipients of food. Persons subject to the 

regulation are required to be in 

compliance by December 9, 2005, June 

9, 2006, or December 11, 2006, 

depending on the size of the business. 

The guidance for industry entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records’’ responds to questions about 

the final rule on records. It is intended 

to help industry better understand and 

comply with the regulation in 21 CFR 

part 1, subpart J. FDA is issuing this 

guidance as a level 1 guidance. The 

guidance represents the agency’s current 

thinking on the topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. Consistent with FDA’s good 

guidance practices regulation 

§ 10.115(g)(2) (21 CFR 10.115(g)(2)), the 

agency will accept comments, but it is 

implementing the guidance document 

immediately, in accordance with 

§ 10.115(g)(2), because the agency has 

determined that prior public 

participation is not feasible or 

appropriate. As noted, the final rule 

requires that covered persons begin to 

establish and maintain records 

identifying the immediate previous 

sources and immediate subsequent 

recipients of food by December 9, 2005, 

June 9, 2006, or December 11, 2006, 

depending on the size of the business. 

Clarifying the provisions of the final 

rule will facilitate prompt compliance 

with these requirements and ensure 

complete implementation of the final 

rule. 

FDA continues to receive large 

numbers of questions regarding the 

records final rule, and is responding to 

these questions under § 10.115 as 

promptly as possible, using a questionand-answer format. The agency believes 

that it is reasonable to maintain all 

responses to questions concerning 

establishment and maintenance of 

records in a single document that is 

periodically updated as the agency 

receives and responds to additional 

questions. The following four indicators 

will be employed to help users of the 

guidance identify revisions: (1) The 

guidance will be identified as a revision 

of a previously issued document, (2) the 

revision date of the guidance will 

appear on its cover, (3) the edition 

number of the guidance will be 

included in its title, and (4) questions 

and answers that have been added to the 

original guidance will be identified as 

such in the body of the guidance. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any