81_FR_67450 81 FR 67260 - BASF Corp.; Filing of Food Additive Petition (Animal Use)

81 FR 67260 - BASF Corp.; Filing of Food Additive Petition (Animal Use)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 190 (September 30, 2016)

Page Range67260-67261
FR Document2016-23645

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.

Federal Register, Volume 81 Issue 190 (Friday, September 30, 2016) 
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Proposed Rules]
[Pages 67260-67261]
From the Federal Register Online  [www.thefederalregister.org]
[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

67260 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Proposed Rules include a general description of the the stress test is performed pursuant to DATES: Submit either electronic or additional component(s) or additional 12 CFR 252.54, unless that time is written comments on FDA’s scenario(s) and the basis for requiring extended by the Board in writing. environmental assessment by October the company to include the additional (2) A covered company must report 31, 2016. component(s) or additional scenario(s). the results of the stress test required ADDRESSES: You may submit comments * * * * * under § 252.55 to the Board in the as follows: (iii) Description of component. The manner and form prescribed by the Board will respond in writing within 14 Board. Such results must be submitted Electronic Submissions calendar days of receipt of the by October 5 of the calendar year in Submit electronic comments in the company’s request. The Board will which the stress test is performed following way: provide the covered company with a pursuant to 12 CFR 252.55, unless that • Federal eRulemaking Portal: http:// description of any additional time is extended by the Board in www.regulations.gov. Follow the component(s) or additional scenario(s) writing. instructions for submitting comments. by March 1 of the calendar year in * * * * * Comments submitted electronically, which the stress test is performed ■ 13. Section 252.58 is amended by including attachments, to http:// pursuant to this section. revising paragraph (a)(1)(ii) to read as www.regulations.gov will be posted to ■ 11. Section 252.55 is amended by follows: the docket unchanged. Because your revising paragraphs (a), (b)(4)(i), and comment will be made public, you are (b)(4)(iii) to read as follows: § 252.58 Disclosure of stress test results. solely responsible for ensuring that your (a) * * * comment does not include any § 252.55 Mid-cycle stress test. (1) * * * confidential information that you or a (a) Mid-cycle stress test requirement. (ii) A covered company must publicly third party may not wish to be posted, In addition to the stress test required disclose a summary of the results of the such as medical information, your or under § 252.54, a covered company stress test required under § 252.55. This anyone else’s Social Security number, or must conduct a mid-cycle stress test. disclosure must occur in the period confidential business information, such The stress test must be conducted by beginning on October 5 and ending on as a manufacturing process. Please note September 30 of each calendar year November 4 of the calendar year in that if you include your name, contact based on data as of June 30 of that which the stress test is performed information, or other information that calendar year, unless the time or the as- pursuant to 12 CFR 252.55, unless that identifies you in the body of your of date is extended by the Board in time is extended by the Board in comment, that information will be writing. writing. (b) * * * posted on http://www.regulations.gov. (4) Notice and response—(i) * * * * * • If you want to submit a comment Notification of additional component. If By order of the Board of Governors of the with confidential information that you the Board requires a covered company Federal Reserve System, September 26, 2016. do not wish to be made available to the to include one or more additional Robert deV. Frierson, public, submit the comment as a components in its adverse and severely Secretary of the Board. written/paper submission and in the adverse scenarios under paragraph (b)(2) [FR Doc. 2016–23629 Filed 9–29–16; 8:45 am] manner detailed (see ‘‘Written/Paper of this section or one or more additional BILLING CODE 6210–01–P Submissions’’ and ‘‘Instructions’’). scenarios under paragraph (b)(3) of this Written/Paper Submissions section, the Board will notify the company in writing. The Board will Submit written/paper submissions as DEPARTMENT OF HEALTH AND follows: provide such notification no later than HUMAN SERVICES June 30. The notification will include a • Mail/Hand delivery/Courier (for general description of the additional Food and Drug Administration written/paper submissions): Division of component(s) or additional scenario(s) Dockets Management (HFA–305), Food and the basis for requiring the company 21 CFR Part 573 and Drug Administration, 5630 Fishers to include the additional component(s) Lane, Rm. 1061, Rockville, MD 20852. or additional scenario(s). [Docket No. FDA–2014–F–0988] • For written/paper comments submitted to the Division of Dockets * * * * * BASF Corp.; Filing of Food Additive (iii) Description of component. The Management, FDA will post your Petition (Animal Use) comment, as well as any attachments, Board will provide the covered company with a description of any AGENCY: Food and Drug Administration, except for information submitted, additional component(s) or additional HHS. marked and identified, as confidential, scenario(s) by September 1 of the ACTION: Notice of petition. if submitted as detailed in calendar year prior to the year in which ‘‘Instructions.’’ the stress test is performed pursuant to SUMMARY: The Food and Drug Instructions: All submissions received this section. Administration (FDA) is announcing must include the Docket No. FDA– ■ 12. Section 252.57 is amended by that BASF Corp., as a part of their 2014–F–0988 for ‘‘Food Additives petition (FAP 2286) proposing that the Permitted in Feed and Drinking Water asabaliauskas on DSK3SPTVN1PROD with PROPOSALS revising paragraph (a) to read as follows: food additive regulations be amended to of Animals; Feed Grade Sodium § 252.57 Reports of stress test results. provide for the safe use of feed grade Formate.’’ Received comments will be (a) Reports to the Board of stress test sodium formate as a feed acidifying placed in the docket and, except for results. (1) A covered company must agent in complete swine feeds, also those submitted as ‘‘Confidential report the results of the stress test proposed that FDA amend the animal Submissions,’’ publicly viewable at required under § 252.54 to the Board in food additive regulations for formic acid http://www.regulations.gov or at the the manner and form prescribed by the and ammonium formate to limit formic Division of Dockets Management Board. Such results must be submitted acid and formate salts from all added between 9 a.m. and 4 p.m., Monday by April 5 of the calendar year in which sources. through Friday. VerDate Sep<11>2014 18:55 Sep 29, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4702 Sfmt 4702 E:\FR\FM\30SEP1.SGM 30SEP1

Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Proposed Rules 67261 • Confidential Submissions—To the animal food additive regulations for ENVIRONMENTAL PROTECTION submit a comment with confidential formic acid (§ 573.480) and ammonium AGENCY information that you do not wish to be formate (§ 573.170) to limit formic acid made publicly available, submit your and formate salts from all added sources 40 CFR Part 52 comment only as a written/paper to 1.2 percent of complete feed when [EPA–R05–OAR–2016–0134; FRL–9953–51– submission. You should submit two multiple sources of formic acid and its Region 5] copies total. One copy will include the salts are used in combination. This information you claim to be confidential element of the petition was not Air Plan Approval; Wisconsin; NOX as with a heading or cover note that states described in the July 25, 2014, notice of a Precursor to Ozone, PM2.5 Increment ‘‘THIS DOCUMENT CONTAINS petition (79 FR 43325). Rules and PSD Infrastructure SIP CONFIDENTIAL INFORMATION.’’ The Requirements Agency will review this copy, including Elsewhere in this issue of the Federal Register, FDA is publishing a regulation AGENCY: Environmental Protection the claimed confidential information, in providing for the safe use of feed grade Agency (EPA). its consideration of comments. The sodium formate as a feed acidifying ACTION: Proposed rule. second copy, which will have the claimed confidential information agent in complete swine feeds. SUMMARY: The Environmental Protection redacted/blacked out, will be available The potential environmental impact Agency (EPA) is proposing approval of for public viewing and posted on http:// of this action is being reviewed. The a revision to Wisconsin’s state www.regulations.gov. Submit both Agency will prepare a claim of implementation plan (SIP), revising copies to the Division of Dockets categorical exclusion or an portions of the State’s Prevention of Management. If you do not wish your environmental assessment to evaluate Significant Deterioration (PSD) and name and contact information to be the potential environmental impacts of ambient air quality programs to address made publicly available, you can these actions. Interested persons may deficiencies identified in EPA’s provide this information on the cover submit to the Division of Dockets previous narrow infrastructure SIP sheet and not in the body of your disapprovals and Finding of Failure to Management (see ADDRESSES) either comments and you must identify this Submit. This SIP revision request is electronic or written comments information as ‘‘confidential.’’ Any consistent with the Federal PSD rules information marked as ‘‘confidential’’ regarding this document. It is only and addresses the required elements of will not be disclosed except in necessary to send one set of comments. the fine particulate matter (PM2.5) PSD accordance with 21 CFR 10.20 and other Identify comments with the docket Increments, Significant Impact Levels applicable disclosure law. For more number found in brackets in the (SILs) and Significant Monitoring information about FDA’s posting of heading of this document. Received Concentration (SMC) Rule. EPA is also comments to public dockets, see 80 FR comments may be seen in the Division proposing to approve elements of SIP 56469, September 18, 2015, or access of Dockets Management between 9 a.m. submissions from Wisconsin regarding the information at: http://www.fda.gov/ and 4 p.m., Monday through Friday. PSD infrastructure requirements of regulatoryinformation/dockets/ FDA will also place on public display section 110 of the Clean Air Act (CAA) default.htm. any comments on potential for the 1997 PM2.5, 1997 ozone, 2006 Docket: For access to the docket to environmental impact without further PM2.5, 2008 lead, 2008 ozone, 2010 read background documents or the announcement in the Federal Register. nitrogen dioxide (NO2), 2010 sulfur electronic and written/paper comments If FDA determines a categorical dioxide (SO2), and 2012 PM2.5 National received, go to http:// exclusion applies, neither an Ambient Air Quality Standards www.regulations.gov and insert the environmental assessment nor an (NAAQS). The infrastructure docket number, found in brackets in the environmental impact statement is requirements are designed to ensure that heading of this document, into the required. If FDA determines a the structural components of each ‘‘Search’’ box and follow the prompts categorical exclusion does not apply, state’s air quality management program and/or go to the Division of Dockets FDA will prepare an environmental are adequate to meet the state’s Management, 5630 Fishers Lane, Rm. assessment and place it on public responsibilities under the CAA. 1061, Rockville, MD 20852. display at the Division of Dockets DATES: Comments must be received on FOR FURTHER INFORMATION CONTACT: Management (see DATES and ADDRESSES) or before October 31, 2016. Chelsea Trull, Center for Veterinary for public review and comment. ADDRESSES: Submit your comments, Medicine, Food and Drug identified by Docket ID No. EPA–R05– Administration, 7519 Standish Pl., Dated: September 26, 2016. OAR–2016–0134 at http:// Rockville, MD 20855, 240–402–6729, Tracey H. Forfa, www.regulations.gov, or via email to chelsea.trull@fda.hhs.gov. Deputy Director, Center for Veterinary damico.genevieve@epa.gov. For SUPPLEMENTARY INFORMATION: Under the Medicine. comments submitted at Regulations.gov, Federal Food, Drug, and Cosmetic Act [FR Doc. 2016–23645 Filed 9–29–16; 8:45 am] follow the online instructions for (section 409(b)(5) (21 U.S.C. 348(b)(5)), BILLING CODE 4164–01–P submitting comments. Once submitted, notice is given that the food additive comments cannot be edited or removed petition (FAP 2286) filed by BASF from Regulations.gov. For either manner asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Corp., 100 Park Ave., Florham Park, NJ of submission, EPA may publish any 07932 proposing to amend Title 21 of comment received to its public docket. the Code of Federal Regulations (CFR) Do not submit electronically any in part 573 Food Additives Permitted in information you consider to be Feed and Drinking Water of Animals (21 Confidential Business Information (CBI) CFR part 573) to provide for the safe use or other information whose disclosure is of feed grade sodium formate as a feed restricted by statute. Multimedia acidifying agent in complete swine submissions (audio, video, etc.) must be feeds, also proposed that FDA amend accompanied by a written comment. VerDate Sep<11>2014 18:55 Sep 29, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4702 Sfmt 4702 E:\FR\FM\30SEP1.SGM 30SEP1


Document Created: 2018-02-09 13:33:48
Document Modified: 2018-02-09 13:33:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of petition.
DatesSubmit either electronic or written comments on FDA's environmental assessment by October 31, 2016.
ContactChelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation81 FR 67260 
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