[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Rules and Regulations]
[Pages 52207-52209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24366]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0988]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Ammonium Formate and Formic Acid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, we, the Agency) is 
amending food additive regulations for food additives permitted in feed 
and drinking water of animals to provide for the safe use of formic 
acid and ammonium formate. This action is in response to a food 
additive petition filed by BASF Corp for Feed Grade Sodium Formate (FAP 
2286), which also proposed to amend the animal food additive 
regulations for formic acid and ammonium formate to limit formic acid 
and formate salts from all added sources.

DATES: This rule is effective November 13, 2017. Submit either written 
or electronic objections and requests for a hearing by December 13, 
2017. See section V of this document for information on the filing of 
objections.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. Electronic objections must be submitted

[[Page 52208]]

on or before December 13, 2017. The https://www.regulations.gov 
electronic filing system will accept objections until midnight Eastern 
Time at the end of December 13, 2017. Objections received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is 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-2014-F-0988 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Ammonium Formate and Formic Acid.'' 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.
     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.gpo.gov/fdsys/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 objections 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.

FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-402-6729, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of July 25, 2014 
(79 FR 43325), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2286) submitted by BASF Corp., 100 Park Ave., Florham 
Park, NJ 07932. 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 feed grade sodium formate as a feed 
acidifying agent in complete swine feeds. The notice of petition 
provided for a 30-day comment period on the petitioner's request for 
categorical exclusion from preparing an environmental assessment or 
environmental impact statement.
    In addition, the petition proposed that the animal food additive 
regulations for formic acid and ammonium formate be amended to limit 
formic acid and formate salts from all added sources to 1.2 percent of 
complete feeds. This element of the petition was not described in the 
July 2014 notice of petition for FAP 2286, but was later described in a 
September 30, 2016, notice of petition (81 FR 67260).

II. Conclusion

    FDA became concerned about the safety of higher levels of formic 
acid and formate salts in complete feeds when multiple sources of 
formic acid and its salts are used in combination. FDA concludes that 
the data establish the safety of formic acid and ammonium formate for 
use as a feed acidifying agent in complete feeds, that formic acid and 
formate salts should be limited to 1.2 percent on complete feed, 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

    The Agency has 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

    Any person who will be adversely affected by this regulation may 
file with the Dockets Management Staff (see ADDRESSES) either 
electronic or written objections. Each objection shall be separately 
numbered, and each numbered objection shall specify with particularity 
the provision of the

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regulation to which objection is made and the grounds for the 
objection. Each numbered objection on which a hearing is requested 
shall specifically so state. Failure to request a hearing for any 
particular objection shall constitute a waiver of the right to a 
hearing on that objection. Each numbered objection for which a hearing 
is requested shall include a detailed description and analysis of the 
specific factual information intended to be presented in support of the 
objection in the event that a hearing is held. Failure to include such 
a description and analysis for any particular objection shall 
constitute a waiver of the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the office of the Dockets Management Staff between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at 
https://www.regulations.gov.

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. In Sec.  573.170, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (e), add new paragraph (c) and paragraph (d)(3) to newly 
redesignated paragraph (d), and revise newly redesignated paragraph (e) 
introductory text to read as follows:


Sec.  573.170  Ammonium formate.

* * * * *
    (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) * * *
    (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 Federal Food, Drug, and Cosmetic Act and 
paragraph (d) of this section, the label and labeling shall contain:
* * * * *

0
3. In Sec.  573.480, redesignate paragraphs (b)(3) and (4) as 
paragraphs (b)(4) and (5), add new paragraph (b)(3) and paragraph 
(b)(4)(iii) to newly redesignated paragraph (b)(4), and revise newly 
redesignated paragraph (b)(5) introductory text to read as follows:


Sec.  573.480  Formic acid.

* * * * *
    (b) * * *
    (3) 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.
    (4) * * *
    (iii) 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.
    (5) To ensure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act and 
paragraph (b)(4) of this section, the label and labeling shall contain:
* * * * *

    Dated: November 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24366 Filed 11-9-17; 8:45 am]
BILLING CODE 4164-01-P