Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Rules and Regulations 77775 

(ii) For Configuration E4A and E4P engines 

with 100 FHs or more since installation as of 

the effective date of this AD: Inspect before 

further flight and thereafter at intervals not 

to exceed 50 FHs. 

(iii) For Configuration E4B and E4C 

engines with less than 200 FHs since 

installation as of the effective date of this AD: 

Inspect within 200 FHs since installation and 

thereafter at intervals not to exceed 100 FHs. 

(iv) For Configuration E4B and E4C engines 

with 200 FHs or more since installation as of 

the effective date of this AD: Inspect before 

further flight and thereafter at intervals not 

to exceed 100 FHs. 

(2) If during any BSI required by paragraph 

(g)(1) of this AD, any crack is found, before 

further flight, do the following: 

(i) Remove from service and replace the 

piston. Replacement of the engine core 

includes piston replacement and would 

satisfy this requirement. 

(ii) Collect a fuel sample from the highpressure pump (HPP) fuel return line and do 

a fuel analysis for water contamination. 

(iii) If during any fuel analysis required by 

paragraph (g)(2)(ii), any water contamination 

is found, remove from service and replace the 

HPP, injectors, and fuel rails. 

(h) Definitions 

For the purpose of this AD: 

(1) ‘‘Configuration E4A engines’’ are Model 

E4 engines with an engine serial number 

(ESN) that begins with ‘‘E4–A– . . .’’ 

(2) ‘‘Configuration E4B engines’’ are Model 

E4 engines with an ESN that begins with 

‘‘E4–B– . . .’’ 

(3) ‘‘Configuration E4C engines’’ are Model 

E4 engines with an ESN that begins with 

‘‘E4–C– . . .’’ 

(4) ‘‘Configuration E4P engines’’ are Model 

E4P engines with an ESN that begins with 

‘‘E4P–B– . . .’’ or ‘‘E4P–C– . . .’’ 

(i) Credit for Previous Actions 

Credit may be taken for BSIs done before 

the effective date of this AD using Austro 

Engine Authorization Request/Occurrence 

Reporting AR1734, dated August 16, 2024. 

(j) Special Flight Permits 

A special flight permit may be issued in 

accordance with 14 CFR 21.197 and 21.199 

to permit a single ferry flight to a location 

where the actions required by this AD can be 

accomplished, provided that the flight is 

accomplished under visual flight rule 

conditions, without passengers, and does not 

exceed 3 FHs. 

(k) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, International Validation 

Branch, 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 manager of the International Validation 

Branch, send it to the attention of the person 

identified in paragraph (l) of this AD and 

email to: AMOC@faa.gov. 

(2) 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. 

(l) Additional Information 

For more information about this AD, 

contact Morton Lee, Aviation Safety 

Engineer, FAA, 1600 Stewart Avenue, Suite 

410, Westbury, NY 11590; phone: (860) 386– 

1791; email: morton.y.lee@faa.gov. 

(m) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the material listed in this paragraph 

under 5 U.S.C. 552(a) and 1 CFR part 51. 

(2) You must use this material as 

applicable to do the actions required by this 

AD, unless the AD specifies otherwise. 

(i) Austro Engine GmbH (Austro) 

Mandatory Service Bulletin No. MSB–E4– 

043/0, dated August 27, 2024. 

(ii) [Reserved] 

(3) For Austro material identified in this 

AD, contact Austro, Rudolf-Diesel-Strasse 11, 

A–2700 Weiner Neustadt, Austria; phone: 

+43 2622 23000; website: austroengine.at. 

(4) You may view this material at the FAA, 

Airworthiness Products Section, Operational 

Safety Branch, 1200 District Avenue, 

Burlington, MA 01803. For information on 

the availability of this material at the FAA, 

call (817) 222–5110. 

(5) You may view this material at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

visit www.archives.gov/federal-register/cfr/ 

ibr-locations or email fr.inspection@nara.gov. 

Issued on September 17, 2024. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2024–21804 Filed 9–19–24; 4:15 pm] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 112 

[Docket No. FDA–2011–N–0921] 

Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption: What You Need 

To Know About the Food and Drug 

Administration Regulation; Small 

Entity Compliance Guide; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

guidance for industry entitled 

‘‘Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption: What You Need 

to Know About the FDA Regulation: 

Small Entity Compliance Guide.’’ We 

are updating the small entity 

compliance guide (SECG) to help small 

entities comply with revised 

requirements related to agricultural 

water in the ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption’’ regulation. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 24, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2011–N–0921 for ‘‘What You Need to 

Know About the FDA Regulation: 


lotter on DSK11XQN23PROD with RULES1
77776 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Rules and Regulations 

Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption—Small Entity 

Compliance Guide.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.govinfo.

gov/content/pkg/FR-2015-09-18/pdf/ 

2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the SECG to the Office of Food 

Safety, Division of Produce Safety 

(HFS–317), Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the SECG. 

FOR FURTHER INFORMATION CONTACT: 

Samir Assar, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1636. 

SUPPLEMENTARY INFORMATION: 

I. Background

In the Federal Register of November

27, 2015 (80 FR 74353), we issued a 

final rule entitled ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption’’ (produce safety rule). 

The produce safety rule, which is 

codified at part 112 (21 CFR part 112), 

established science-based minimum 

standards for the safe growing, 

harvesting, packing, and holding of 

produce, meaning fruits and vegetables 

grown for human consumption. On 

September 6, 2017 (82 FR 42031) we 

announced the availability of a guidance 

for industry entitled ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption: What You Need to Know 

About the FDA Regulation: Small Entity 

Compliance Guide’’ to help small 

entities comply with the produce safety 

rule. 

In the Federal Register of May 6, 2024 

(89 FR 37448), we issued a final rule 

entitled, ‘‘Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption 

Relating to Agricultural Water’’ 

(agricultural water final rule) that 

revised certain requirements in subpart 

E of part 112 (21 CFR 112.40 through 

112.50) of the produce safety rule 

applicable to pre-harvest agricultural 

water for covered produce (other than 

sprouts). The agricultural water final 

rule is effective July 5, 2024. The final 

rule establishes compliance dates for the 

pre-harvest agricultural water 

provisions for covered produce (other 

than sprouts) beginning on April 7, 

2025, with date staggering based on 

farm size. 

We examined the economic 

implications of the agricultural water 

final rule as required by the Regulatory 

Flexibility Act (5 U.S.C. 601–612) and 

determined that the final rule might 

have a significant economic impact on 

a substantial number of small entities. 

In compliance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (Pub. L. 104–121, as 

amended by Pub. L. 110–28), we are 

making available the SECG to explain 

the actions that a small entity must take 

to comply with the rule. 

We are issuing the SECG consistent 

with our good guidance practices 

regulation (21 CFR 10.115(c)(2)). The 

SECG represents the current thinking of 

FDA on this topic. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995

While this guidance contains no

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in part 112 have been 

approved under OMB control number 

0910–0816. 

III. Electronic Access

Persons with access to the internet

may obtain the SECG at either https:// 

www.fda.gov/FoodGuidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: September 19, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21840 Filed 9–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2024–0796] 

RIN 1625–AA00 

Safety Zone; Allegheny River Mile 

Marker 0.5 to 0.75, Pittsburgh, PA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

the Allegheny River on September 28, 

2024, at mile marker 0.5 to mile marker 

0.75 from 8 p.m. through 9:30 p.m. This 

safety zone is necessary to provide for 

the safety of life on the navigable waters 

during a drone display. Entry of vessels 

or persons into this zone is prohibited 

unless specifically authorized by the 


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