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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Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Rules and Regulations 77777 

Captain of the Port, Pittsburgh, or a 

designated representative. 

DATES: This rule is effective 8 p.m. 

through 9:30 p.m. on September 28, 

2024. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2024– 

0796 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this rule, call 

or email Marine Science Technician 

First Class Brett Lanzel, Marine Safety 

Unit Pittsburgh, U.S. Coast Guard, at 

telephone 206–815–6624, email 

Brett.J.Lanzel@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule under the authority in 5 

U.S.C. 553(b)(B). This statutory 

provision authorizes an agency to issue 

a rule without prior notice and 

opportunity to comment when the 

agency for good cause finds that those 

procedures are ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ The Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because it is 

impracticable. We must establish this 

safety zone by September 28, 2024, and 

lack sufficient time to provide a 

reasonable comment period and then 

consider those comments before issuing 

this rule. 

Also, under 5 U.S.C. 553(d)(3), the 

Coast Guard finds that good cause exists 

for making this rule effective less than 

30 days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable and 

contrary to the public interest because 

action is needed by September 28, 2024, 

to ensure the safety of life on the 

navigable waters during the drone 

display. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034. The 

Captain of the Port Pittsburgh (COTP) 

has determined that potential hazards 

associated with a drone show on 

September 28, 2024, will be a safety 

concern for anyone on the Allegheny 

River at mile marker 0.5 to mile marker 

0.75 from 8 p.m. to 9:30 p.m. This rule 

is needed to protect participants, 

vessels, and the navigable waters in the 

safety zone, before, during, and after the 

scheduled event. 

IV. Discussion of the Rule 

This rule establishes a safety zone 

from 8 p.m. until 9:30 p.m. on 

September 28, 2024. The safety zone 

will cover all navigable waters between 

mile marker 0.5 to 0.75 on the 

Allegheny River. The duration of the 

zone is intended to protect personnel, 

vessels, and the marine environment in 

these navigable waters during a drone 

display. No vessel or person will be 

permitted to enter the safety zone 

without obtaining permission from the 

COTP or a designated representative. To 

seek permission to enter, contact the 

COTP or designated representative via 

VHF–FM channel 16, or through Marine 

Safety Unit Pittsburgh at 206–815–6624. 

Persons and vessels permitted to enter 

the safety zone must comply with all 

lawful orders or directions issued by the 

COTP or designated representative. The 

COTP or a designated representative 

will inform the public of the effective 

period for the safety zone as well as any 

changes in the dates and times of 

enforcement through Local Notice to 

Mariners (LNMs), Broadcast Notice to 

Mariners (BNMs), and/or Marine Safet 

Information Bulletins (MSIBs), as 

appropriate. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This rule has not been designated a 

‘‘significant regulatory action,’’ under 

section 3(f) of Executive Order 12866, as 

amended by Executive Order 14094 

(Modernizing Regulatory Review). 

Accordingly, this rule has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This regulatory action determination 

is based on size, location, and duration 

of the temporary safety zone. This safety 

zone only impacts a 0.25 mile stretch on 

the Allegheny River for 90 minutes on 

September 28, 2024. Moreover, the 

Coast Guard will issue Local Notice to 

Mariners and/or Broadcast Notice to 

Mariners via VHF–FM marine channel 

16 about the zone and the rule allows 

vessels to seek permission from the 

COTP to transit the zone. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard certifies under 5 U.S.C. 

605(b) that this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

While some owners or operators of 

vessels intending to transit the safety 

zone may be small entities, for the 

reasons stated in section V.A above, this 

rule will not have a significant 

economic impact on any vessel owner 

or operator. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this rule. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 


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77778 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Rules and Regulations 

C. Collection of Information 

This rule will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has 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. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

Tribes, on the relationship between the 

Federal Government and Indian Tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or Tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves a safety 

zone lasting only 90 minutes that will 

prohibit entry within mile marker 0.5 

through 0.75 on the Allegheny River. It 

is categorically excluded from further 

review under paragraph L60(a) of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places, or vessels. 

List of Subjects in 33 CFR Part 165 

Marine safety, Navigation (water), 

Reporting, Recordkeeping requirements, 

and Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051, 70124; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.3. 

■ 2. Add § 165.T08–0796 to read as 

follows: 

§ 165.T08–0796 Safety Zone; Allegheny 

River Mile Marker 0.5 to 0.75, Pittsburgh, 

PA. 

(a) Location. The following area is a 

safety zone: All navigable waters on the 

Allegheny River between mile marker 

0.5 and mile marker 0.75. 

(b) Definitions. As used in this 

section, designated representative 

means a Coast Guard Patrol 

Commander, including a Coast Guard 

coxswain, petty officer, or other officer 

operating a Coast Guard vessel and a 

Federal, State, and local officer 

designated by or assisting the Captain of 

the Port Pittsburgh (COTP) in the 

enforcement of the safety zone. 

(c) Regulations. (1) Under the general 

safety zone regulations in subpart C of 

this part, you may not enter the safety 

zone described in paragraph (a) of this 

section unless authorized by the COTP 

or the COTP’s designated representative; 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by VFH Channel 16, or 

through Marine Safety Unit Pittsburgh 

at 206–815–6624. Those in the safety 

zone must comply with all lawful orders 

or directions given to them by the COTP 

or the COTP’s designated representative. 

(d) Enforcement period. This section 

will be enforced from 8 p.m. to 9:30 

p.m. on September 28, 2024. 

Dated: September 18, 2024. 

Justin R. Jolley, 

Commander, U.S. Coast Guard, Captain of 

the Port, MSU Pittsburgh. 

[FR Doc. 2024–21839 Filed 9–23–24; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2024–0806] 

RIN 1625–AA00 

Safety Zone; Ohio River, New Albany, 

IN 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the Ohio River, from Mile Markers 

606.5–609.6. The safety zone is needed 

to ensure the safety of spectators during 

the Fall Break Blast firework display. 

Entry of vessels or persons into this 

zone is prohibited unless specifically 

authorized by the Captain of the Port, 

Sector Ohio Valley. 

DATES: This rule is effective from 8:30 

p.m. to 10:30 p.m. on September 27, 

2024. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2024– 

0806 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this rule, call 

or email Petty Officer Second Class 

Dalton Johnson, U.S. Coast Guard; 

telephone 502–779–5334, email 

SECOHV-WWM@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule under authority in 5 


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