87670 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Rules and Regulations 

Comp., p. 950; E.O. 13026, 61 FR 58767, 3 

CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 

45167, 3 CFR, 1998 Comp., p. 208; E.O. 

13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 

783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 

Comp., p. 786; Notice of November 8, 2022, 

87 FR 68015, 3 CFR, 2022 Comp., p. 563; 

Notice of September 7, 2023, 88 FR 62439 

(September 11, 2023). 

■ 2. Supplement No. 6 to Part 744 is 

amended under CHINA, PEOPLE’S 

REPUBLIC OF, by removing the entries 

for ‘‘Chengde Oscillator Electronic 

Technology Co.’’, ‘‘China National 

Erzhong Group’’, ‘‘Ningbo III Lasers 

Technology Co., Ltd.’’, and ‘‘Xinjiang 

East Hope New Energy Company Ltd’’. 

Thea D. Rozman Kendler, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2023–27932 Filed 12–15–23; 11:15 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 573 

[Docket No. FDA–2020–F–0151] 

Food Additives Permitted in Feed and 

Drinking Water of Animals; Calcium 

Formate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) is amending the regulations for 

food additives permitted in feed and 

drinking water of animals to provide for 

the safe use of calcium formate as a feed 

acidifying agent, to lower the pH, in 

complete swine and poultry feeds at 

levels not to exceed 1.2 percent of the 

complete feed. This action is in 

response to a food additive petition filed 

by LANXESS Corp. 

DATES: This rule is effective December 

19, 2023. See section V for further 

information on the filing of objections. 

Either electronic or written objections 

and requests for a hearing on the final 

rule must be submitted by January 18, 

2024. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of January 18, 2024. Objections received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting objections. 

Objections submitted electronically, 

including attachments, to https:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 

objection will be made public, you are 

solely responsible for ensuring that your 

objection 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 

objection, that information will be 

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

• If you want to submit an objection 

with confidential information that you 

do not wish to be made available to the 

public, submit the objection 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 objections 

submitted to the Dockets Management 

Staff, FDA will post your objection, 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– 

2020–F–0151 for ‘‘Food Additives 

Permitted in Feed and Drinking Water 

of Animals; Calcium Formate.’’ 

Received objections, those filed in a 

timely manner (see ADDRESSES), 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 an objection with confidential 

information that you do not wish to be 

made publicly available, submit your 

objections only as a written/paper 

submission. You should submit two 

copies in 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 objections. 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 objections 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. 

FOR FURTHER INFORMATION CONTACT: 

Wasima Wahid, Center for Veterinary 

Medicine (HFV–221), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–5857, 

wasima.wahid@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a document published in the 

Federal Register of February 11, 2020 

(85 FR 7682), FDA announced that we 

had filed a food additive petition 

(animal use) (FAP 2310) submitted by 

LANXESS Corp., 111 RIDC Park West 

Dr., Pittsburgh, PA 15275. The petition 

proposed that the regulations for food 

additives permitted in feed and drinking 

water of animals be amended to provide 

for the safe use of calcium formate as a 

feed acidifying agent, to lower the pH, 

in complete feeds for swine or poultry. 


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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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