[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Proposed Rules]
[Pages 67260-67261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

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


BASF Corp.; Filing of Food Additive Petition (Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that BASF 
Corp., as a part of their petition (FAP 2286) proposing that the food 
additive regulations be amended to provide for the safe use of feed 
grade sodium formate as a feed acidifying agent in complete swine 
feeds, also proposed that FDA amend the animal food additive 
regulations for formic acid and ammonium formate to limit formic acid 
and formate salts from all added sources.

DATES: Submit either electronic or written comments on FDA's 
environmental assessment by October 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
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 comment, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, 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; Feed Grade Sodium Formate.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 67261]]

     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comment only as a written/paper submission. You 
should submit two copies 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 comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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 comments 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that the 
food additive petition (FAP 2286) filed by BASF Corp., 100 Park Ave., 
Florham Park, NJ 07932 proposing to amend Title 21 of the Code of 
Federal Regulations (CFR) in part 573 Food Additives Permitted in Feed 
and Drinking Water of Animals (21 CFR part 573) to provide for the safe 
use of feed grade sodium formate as a feed acidifying agent in complete 
swine feeds, also proposed that FDA amend the animal food additive 
regulations for formic acid (Sec.  573.480) and ammonium formate (Sec.  
573.170) to limit formic acid and formate salts from all added sources 
to 1.2 percent of complete feed when multiple sources of formic acid 
and its salts are used in combination. This element of the petition was 
not described in the July 25, 2014, notice of petition (79 FR 43325).
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a regulation providing for the safe use of feed grade sodium formate as 
a feed acidifying agent in complete swine feeds.
    The potential environmental impact of this action is being 
reviewed. The Agency will prepare a claim of categorical exclusion or 
an environmental assessment to evaluate the potential environmental 
impacts of these actions. Interested persons may submit to the Division 
of Dockets Management (see ADDRESSES) either electronic or written 
comments regarding this document. It is only necessary to send one set 
of comments. Identify comments with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. FDA will also place on public display any comments on 
potential environmental impact without further announcement in the 
Federal Register. If FDA determines a categorical exclusion applies, 
neither an environmental assessment nor an environmental impact 
statement is required. If FDA determines a categorical exclusion does 
not apply, FDA will prepare an environmental assessment and place it on 
public display at the Division of Dockets Management (see DATES and 
ADDRESSES) for public review and comment.

    Dated: September 26, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-23645 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P