Document ID: FDA-2020-F-0151-0002
Agency: fda
Document Type: Rule
Title: Food Additives Permitted in Feed and Drinking Water of Animals; Calcium Formate
Posted Date: 2023-12-19T05:00Z

[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Rules and Regulations]
[Pages 87670-87671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27857]

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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.

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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, [email protected].

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.

[[Page 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 Sec.  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 Sec.  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

0
1. The authority citation for part 573 continues to read as follows:

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

0
2. Add Sec.  573.230 to subpart B to read as follows:

Sec.  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