Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Rules and Regulations 87671 

II. Conclusion 

FDA concludes that the data establish 

the safety and utility of calcium formate 

as a feed acidifying agent, to lower the 

pH, in complete feeds for swine or 

poultry, and that the food additive 

regulations should be amended as set 

forth in this document. 

III. Public Disclosure 

In accordance with § 571.1(h) (21 CFR 

571.1(h)), the petition and documents 

we considered and relied upon in 

reaching our decision to approve the 

petition will be made available for 

public disclosure (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 571.1(h), we will delete from the 

documents any materials that are not 

available for public disclosure. 

IV. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.32(r) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

V. Objections and Hearing Requests 

If you will be adversely affected by 

one or more provisions of this 

regulation, you may file with the 

Dockets Management Staff (see 

ADDRESSES) either electronic or written 

objections. You must separately number 

each objection, and within each 

numbered objection you must specify 

with particularity the provision(s) to 

which you object, and the grounds for 

your objection. Within each numbered 

objection, you must specifically state 

whether you are requesting a hearing on 

the particular provision that you specify 

in that numbered objection. If you do 

not request a hearing for any particular 

objection, you waive the right to a 

hearing on that objection. If you request 

a hearing, your objection must include 

a detailed description and analysis of 

the specific factual information you 

intend to present in support of the 

objection in the event that a hearing is 

held. If you do not include such a 

description and analysis for any 

particular objection, you waive the right 

to a hearing on the objection. 

List of Subjects in 21 CFR Part 573 

Animal feeds, Food additives. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 573 is 

amended as follows: 

PART 573—FOOD ADDITIVES 

PERMITTED IN FEED AND DRINKING 

WATER OF ANIMALS 

■ 1. The authority citation for part 573 

continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348. 

■ 2. Add § 573.230 to subpart B to read 

as follows: 

§ 573.230 Calcium formate. 

The food additive calcium formate 

may be safely used in the manufacture 

of complete swine and poultry feeds in 

accordance with the following 

prescribed conditions: 

(a) The additive is manufactured by 

the reaction of butyraldehyde, 

formaldehyde, calcium hydroxide, and 

formic acid in water followed by 

purification and dried to produce a 

powder consisting of not less than 99.0 

percent calcium formate (CAS 544–17– 

2). The additive meets the following 

specifications: 

(1) The additive consists of minimum 

30.5 percent calcium and minimum 68.5 

percent formate. 

(2) Trimethylolpropane (TMP) not to 

exceed 125 parts per million. 

(b) The additive is used or intended 

for use as a feed acidifying agent, to 

lower the pH, in complete swine or 

poultry feeds at levels not to exceed 1.2 

percent of the complete feed. 

(c) To ensure safe use of the additive, 

formic acid and formate salts from all 

added sources cannot exceed 1.2 

percent of complete feed when multiple 

sources of formic acid and its salts are 

used in combination. 

(d) To ensure safe use of the additive, 

in addition to the other information 

required by the Federal Food, Drug, and 

Cosmetic Act, the label and labeling 

shall contain: 

(1) The name of the additive. 

(2) Adequate directions for use 

including a statement that calcium 

formate must be uniformly applied and 

thoroughly mixed into complete feeds 

and that the complete feeds so treated 

shall be labeled as containing calcium 

formate. 

(3) Cautions for use including this 

statement: Caution: Follow label 

directions. Formic acid and formate 

salts from all added sources cannot 

exceed 1.2 percent of complete feed 

when multiple sources of formic acid 

and its salts are used in combination. 

(e) To ensure safe use of the additive, 

in addition to the other information 

required by the act and paragraph (d) of 

this section, the label and labeling shall 

contain: 

(1) Appropriate warnings and safety 

precautions concerning calcium 

formate. 

(2) Statements identifying calcium 

formate as a possible severe irritant. 

(3) Information about emergency aid 

in case of accidental exposure as 

follows. 

(i) Statements reflecting requirements 

of applicable sections of the Superfund 

Amendments and Reauthorization Act, 

and the Occupational Safety and Health 

Administration’s (OSHA) human safety 

guidance regulations. 

(ii) Contact address and telephone 

number for reporting adverse reactions 

or to request a copy of the Safety Data 

Sheet (SDS). 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27857 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 181 

[Public Notice: 12266] 

RIN 1400–AF63 

Publication, Coordination, and 

Reporting of International Agreements: 

Amendments; Correction 

AGENCY: Department of State. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Department of State 

(‘‘Department’’) finalizes regulations 

regarding the publication, coordination, 

and reporting of international 

agreements, which were published for 

comment on October 2. No comments 

were received. In addition, the 

Department is amending one of the 

provisions to remove misleading text in 

the description of the criteria with 

respect to qualifying non-binding 

instruments in the amended rule. 

DATES: This rule is effective on 

December 19, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Michael Mattler, Assistant Legal 

Adviser for Treaty Affairs, Office of the 

Legal Adviser, Department of State, 

Washington, DC 20520, (202) 647–1345, 

or at treatyoffice@state.gov. 

SUPPLEMENTARY INFORMATION: On 

October 2, 2023, the Department 

published a rulemaking (the ‘‘final 

rule’’) that amended 22 CFR part 181 to 

implement section 5947 of the National 

Defense Authorization Act for Fiscal 

Year (FY) 2023 (Pub. L. 117–263) (‘‘the 

NDAA’’). Section 5947 amended 1 

U.S.C. 112a and 1 U.S.C. 112b, known 

as the Case-Zablocki Act, regarding the 

publication, coordination, and reporting 


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87672 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Rules and Regulations 

to Congress of international agreements. 

For further background, see the final 

rule at 88 FR 67643. 

The Department provided 30 days for 

public comment. No comments were 

received. 

Amendment to § 181.4 

The Department is removing the 

phrase ‘‘no single criterion or factor by 

itself is determinative’’ from 

§ 181.4(b)(3)(i). The words were 

included in error, and this change is 

intended to avoid the regulation being 

interpreted to mean that a non-binding 

instrument could only constitute a 

qualifying non-binding instrument if 

multiple factors among those listed in 

(b)(3)(i)(A) through (G) weighed in favor 

of its significance. 

Regulatory Analysis 

Administrative Procedures Act 

As with the original rulemaking, the 

Department is issuing this rule as a final 

rule, asserting the ‘‘good cause’’ 

exemption to the Administrative 

Procedure Act (5 U.S.C. 553(b)). We are 

past the deadline provided by Congress 

to implement this rule, also past the 

effective date of the statute itself. See 

the final rule for more information. 

Regulatory Flexibility Act/Executive 

Order 13272: Small Business 

This rulemaking is hereby certified as 

not expected to have a significant 

impact on a substantial number of small 

entities under the criteria of the 

Regulatory Flexibility Act, 5 U.S.C. 601 

et seq. 

Congressional Review Act 

This rulemaking does not constitute a 

major rule, as defined by 5 U.S.C. 804, 

for purposes of congressional review of 

agency rulemaking. 

The Unfunded Mandates Reform Act of 

1995 

The Unfunded Mandates Reform Act 

of 1995, 2 U.S.C. 1532, generally 

requires agencies to prepare a statement 

before proposing any rule that may 

result in an annual expenditure of $100 

million or more by State, local, or tribal 

governments, or by the private sector. 

This rule will not result in any such 

expenditure nor would it significantly 

or uniquely affect small governments. 

Executive Orders 12372 and 13132: 

Federalism and Executive Order 13175, 

Impact on Tribes 

This rule will 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 national government. Nor will 

the regulations have federalism 

implications warranting the application 

of Executive Orders 12372 and 13132. 

This rule will not have tribal 

implications, will not impose costs on 

Indian tribal governments, and will not 

pre-empt tribal law. Accordingly, the 

requirements of Executive Order 13175 

do not apply to this rulemaking. 

Executive Orders 12866 and 14094; 

13563: Regulatory Review 

This rule has been drafted in 

accordance with the principles of 

Executive Order 12866, as amended by 

Executive Order 14094, and 13563. The 

rulemaking is mandated by a 

Congressional statute; therefore, 

Congress determined that the benefits of 

this rulemaking outweigh the costs. This 

rule has been determined to be a 

significant rulemaking under Executive 

Order 12866. 

Executive Order 12988: Civil Justice 

Reform 

This rule has been reviewed in light 

of sections 3(a) and 3(b)(2) of Executive 

Order 12988 to eliminate ambiguity, 

minimize litigation, establish clear legal 

standards, and reduce burden. 

The Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (44 U.S.C. 3501 et seq.), Federal 

agencies must obtain approval from 

OMB for each collection of information 

they conduct, sponsor, or require 

through regulation. This rule contains 

no new collection of information 

requirements. 

List of Subjects in 22 CFR Part 181 

Treaties. 

For the reasons set forth above, the 

State Department amends 22 CFR part 

181 as follows: 

PART 181—COORDINATION, 

REPORTING AND PUBLICATION OF 

INTERNATIONAL AGREEMENTS 

■ 1. The authority section for part 181 

continues to read as follows: 

Authority: 1 U.S.C. 112a, 112b; and 22 

U.S.C. 2651a. 

■ 2. In § 181.43, revise paragraph 

(b)(3)(i) introductory text to read as 

follows: 

§ 181.4 Criteria with respect to qualifying 

non-binding instruments. 

* * * * * 

(b) * * * 

(3) * * * 

(i) Consistent with 1 U.S.C. 

112b(k)(5)(A)(ii)(I), and except for a 

non-binding instrument referred to in 1 

U.S.C. 112b(k)(5)(B), a non-binding 

instrument that could reasonably be 

expected to have a significant impact on 

the foreign policy of the United States, 

and that meets the other elements set 

out in 1 U.S.C. 112b(k)(5), is a 

qualifying non-binding instrument 

within the meaning of the Act. The 

degree of significance of any particular 

instrument requires an objective 

wholistic assessment. In deciding 

whether a particular instrument meets 

the significance standard, the entire 

context of the transaction, including the 

factors set out below and the 

expectations and intent of the 

participants, must be taken into 

account. Factors that may be relevant in 

determining whether a non-binding 

instrument could reasonably be 

expected to have a significant impact on 

the foreign policy of the United States 

include whether, and to what extent, the 

instrument: 

* * * * * 

Joshua L. Dorosin, 

Deputy Legal Adviser, Department of State. 

[FR Doc. 2023–27837 Filed 12–18–23; 8:45 am] 

BILLING CODE 4710–08–P 

DEPARTMENT OF TRANSPORTATION 

Federal Highway Administration 

23 CFR Parts 470, 635 and 655 

[FHWA Docket No. FHWA–2020–0001] 

RIN 2125–AF85 

National Standards for Traffic Control 

Devices; the Manual on Uniform Traffic 

Control Devices for Streets and 

Highways; Revision 

AGENCY: Federal Highway 

Administration (FHWA), U.S. 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: The Manual on Uniform 

Traffic Control Devices for Streets and 

Highways (MUTCD) (also referred to as 

‘‘the Manual’’) is incorporated by 

reference within our regulations, 

approved by FHWA, and recognized as 

the national standard for traffic control 

devices used on all public roads, 

bikeways, or private roads open to 

public travel. The purpose of this final 

rule is to revise Standard, Guidance, 

Option provisions, and supporting 

information, relating to the traffic 

control devices in all parts of the 

MUTCD to improve safety for all road 

users by promoting uniformity, and to 

incorporate new provisions that reflect 


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