Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 573
          - [Docket No. FDA-2014-F-0988]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Final rule.

# 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                               ( print 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,                         *chelsea.trull@fda.hhs.gov.*

# 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 § 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

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                           ( print page 52209)                        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

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

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

2. In § 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: 

§ 573.170 

* * * * *

(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:

* * * * *

3. In § 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: 

§ 573.480 

* * * * *

(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