81_FR_95274 81 FR 95026 - Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate

81 FR 95026 - Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 248 (December 27, 2016)

Page Range95026-95027
FR Document2016-31079

The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp.

Federal Register, Volume 81 Issue 248 (Tuesday, December 27, 2016) 
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 95026-95027]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31079]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-4282]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Feed Grade Sodium Formate

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 the regulations for food additives permitted in feed and 
drinking water of animals to provide for the safe use of feed grade 
sodium formate as a feed acidifying agent in complete poultry feeds. 
This action is in response to a food additive petition filed by BASF 
Corp.

DATES: This rule is effective December 27, 2016. Submit either written 
or electronic objections and requests for a hearing by January 26, 
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:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Division of 
Dockets Management, 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-2015-F-4282 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Feed Grade Sodium Formate.'' Received objections will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 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 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 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: 

I. Background

    In a notice published in the Federal Register of November 24, 2015 
(80 FR 73153), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2293) 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 poultry feeds.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
feed grade sodium formate for use as a feed acidifying agent in 
complete poultry feeds 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 the documents that 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.

[[Page 95027]]

IV. 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 Division of Dockets Management (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 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 Division of Dockets Management 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 and 
redelegated to the Center for Veterinary Medicine, 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.  573.696, revise the introductory text and paragraph (b) to 
read as follows:


Sec.  573.696   Feed grade sodium formate.

    The food additive, feed grade sodium formate, may be safely used in 
the manufacture of complete swine and poultry feeds in accordance with 
the following prescribed conditions:
* * * * *
    (b) The additive is used or intended for use 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.
* * * * *

    Dated: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31079 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P

95026 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 140–340, 140–443, 140–947, 141–090, third party may not wish to be posted, made publicly available, you can 200–171, 200–569, 200–570, and 200– such as medical information, your or provide this information on the cover 580, and all supplements and anyone else’s Social Security number, or sheet and not in the body of your amendments thereto, is hereby confidential business information, such objections and you must identify this withdrawn, effective December 31, as a manufacturing process. Please note information as ‘‘confidential.’’ Any 2016. that if you include your name, contact information marked as ‘‘confidential’’ Elsewhere in this issue of the Federal information, or other information that will not be disclosed except in Register, FDA is amending the animal identifies you in the body of your accordance with 21 CFR 10.20 and other drug regulations to reflect the voluntary objection, that information will be applicable disclosure law. For more withdrawal of approval of these posted on https://www.regulations.gov. information about FDA’s posting of applications. • If you want to submit an objection comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access Dated: December 20, 2016. do not wish to be made available to the the information at: http://www.fda.gov/ Tracey H. Forfa, public, submit the objection as a regulatoryinformation/dockets/ Deputy Director, Center for Veterinary written/paper submission and in the default.htm. Medicine. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to [FR Doc. 2016–31082 Filed 12–23–16; 8:45 am] Submissions’’ and ‘‘Instructions’’). read background documents or the BILLING CODE 4164–01–P electronic and written/paper objections Written/Paper Submissions received, go to https:// Submit written/paper submissions as www.regulations.gov and insert the DEPARTMENT OF HEALTH AND follows: docket number, found in brackets in the HUMAN SERVICES • Mail/Hand delivery/Courier (for heading of this document, into the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Food and Drug Administration Dockets Management (HFA–305), Food and/or go to the Division of Dockets and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. 21 CFR Part 573 Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. [Docket No. FDA–2015–F–4282] • For written/paper objections FOR FURTHER INFORMATION CONTACT: submitted to the Division of Dockets Chelsea Trull, Center for Veterinary Food Additives Permitted in Feed and Management, FDA will post your Medicine, Food and Drug Drinking Water of Animals; Feed Grade objection, as well as any attachments, Administration, 7519 Standish Pl., Sodium Formate except for information submitted, Rockville, MD 20855, 240–402–6729, marked and identified, as confidential, chelsea.trull@fda.hhs.gov. AGENCY: Food and Drug Administration, if submitted as detailed in HHS. SUPPLEMENTARY INFORMATION: ‘‘Instructions.’’ ACTION: Final rule. Instructions: All submissions received I. Background must include the Docket No. FDA– In a notice published in the Federal SUMMARY: The Food and Drug 2015–F–4282 for ‘‘Food Additives Administration (FDA, we, the Agency) Register of November 24, 2015 (80 FR Permitted in Feed and Drinking Water 73153), FDA announced that we had is amending the regulations for food of Animals; Feed Grade Sodium additives permitted in feed and drinking filed a food additive petition (animal Formate.’’ Received objections will be use) (FAP 2293) submitted by BASF water of animals to provide for the safe placed in the docket and, except for use of feed grade sodium formate as a Corp., 100 Park Ave., Florham Park, NJ those submitted as ‘‘Confidential 07932. The petition proposed that the feed acidifying agent in complete Submissions,’’ publicly viewable at poultry feeds. This action is in response regulations for food additives permitted https://www.regulations.gov or at the in feed and drinking water of animals be to a food additive petition filed by BASF Division of Dockets Management Corp. amended to provide for the safe use of between 9 a.m. and 4 p.m., Monday feed grade sodium formate as a feed DATES: This rule is effective December through Friday. acidifying agent in complete poultry 27, 2016. Submit either written or • Confidential Submissions—To feeds. electronic objections and requests for a submit an objection with confidential hearing by January 26, 2017. See section information that you do not wish to be II. Conclusion V of this document for information on made publicly available, submit your FDA concludes that the data establish the filing of objections. objections only as a written/paper the safety and utility of feed grade ADDRESSES: You may submit objections submission. You should submit two sodium formate for use as a feed and requests for a hearing as follows: copies total. One copy will include the acidifying agent in complete poultry information you claim to be confidential feeds and that the food additive Electronic Submissions with a heading or cover note that states regulations should be amended as set Submit electronic objections in the ‘‘THIS DOCUMENT CONTAINS forth in this document. following way: CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: Agency will review this copy, including III. Public Disclosure https://www.regulations.gov. Follow the the claimed confidential information, in In accordance with § 571.1(h) (21 CFR instructions for submitting comments. its consideration of objections. The 571.1(h)), the petition and the asabaliauskas on DSK3SPTVN1PROD with RULES Objections submitted electronically, second copy, which will have the documents that we considered and including attachments, to https:// claimed confidential information relied upon in reaching our decision to www.regulations.gov will be posted to redacted/blacked out, will be available approve the petition will be made the docket unchanged. Because your for public viewing and posted on available for public disclosure (see FOR objection will be made public, you are https://www.regulations.gov. Submit FURTHER INFORMATION CONTACT). As solely responsible for ensuring that your both copies to the Division of Dockets provided in § 571.1(h), we will delete objection does not include any Management. If you do not wish your from the documents any materials that confidential information that you or a name and contact information to be are not available for public disclosure. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00118 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 95027 IV. Environmental Impact manufacture of complete swine and collection centers, or Justice for The Agency has determined under 21 poultry feeds in accordance with the collection by further administrative CFR 25.32(r) that this action is of a type following prescribed conditions: action or litigation, as applicable. The that does not individually or * * * * * regulations do not apply to claims cumulatively have a significant effect on (b) The additive is used or intended between federal agencies. The rules the human environment. Therefore, for use as a feed acidifying agent, to affect USADF’s debtors. The regulations neither an environmental assessment, lower the pH, in complete swine and clarify and prescribe the steps USADF nor an environmental impact statement poultry feeds at levels not to exceed 1.2 must take before initiating debt is required. percent of the complete feed. collection to ensure that individuals’ rights are protected. These steps include * * * * * V. Objections and Hearing Requests notifying the debtor of the debt and the Dated: December 20, 2016. consequences of failing to resolve the Any person who will be adversely affected by this regulation may file with Tracey H. Forfa, debt. the Division of Dockets Management Deputy Director, Center for Veterinary Medicine. II. Section-by-Section Analysis (see ADDRESSES) either electronic or [FR Doc. 2016–31079 Filed 12–23–16; 8:45 am] Subpart A announces the purpose and written objections. Each objection shall scope of the regulations, defines terms be separately numbered, and each BILLING CODE 4164–01–P used in Part 1506, and addresses numbered objection shall specify with whether USADF can impose sanctions particularity the provision of the AFRICAN DEVELOPMENT or remedies other than those prescribed regulation to which objection is made FOUNDATION in Part 1506, whether USADF will and the grounds for the objection. Each subdivide a claim exceeding $100,000, numbered objection on which a hearing 22 CFR Part 1506 and how claims involving fraud are is requested shall specifically so state. processed. Failure to request a hearing for any RIN 3005–AA00 Subpart B describes the steps particular objection shall constitute a involved in a collection action, waiver of the right to a hearing on that Collection of Claims including the information USADF objection. Each numbered objection for includes in a written demand for which a hearing is requested shall AGENCY: U.S. African Development Foundation. payment, a debtor’s request for review include a detailed description and of a claim, the determination of interest, analysis of the specific factual ACTION: Final rule. penalty and administrative costs, and information intended to be presented in the reporting and consequences of SUMMARY: The U.S. African support of the objection in the event delinquent debts. Development Foundation (USADF) is that a hearing is held. Failure to include Subpart C provides for salary offset revising its regulations on collection of such a description and analysis for any collection procedures, notice and claims in accordance with the Debt particular objection shall constitute a hearing requirements prior to offset, and Collection Improvement Act of 1996 waiver of the right to a hearing on the USADF’s use of offset for claims of (DCIA), as implemented by the objection. another Federal agency. Any objections received in response Department of Justice (Justice) and the Department of the Treasury (Treasury) Subpart D addresses the compromise to the regulation may be seen in the of debts through reduction or Division of Dockets Management in the revised Federal Claims Collection Standards (FCCS). The FCCS prescribes negotiation of the claim amount, joint between 9 a.m. and 4 p.m., Monday and several liability on a claim, and through Friday, and will be posted to the standards that Federal agencies must use in the administrative collection, releasing the debtor after full payment the docket at https:// of a compromised amount. www.regulations.gov. offset, compromise, and suspension or termination of collection activity for Subpart E prescribes the List of Subjects in 21 CFR Part 573 civil claims of money, funds, or circumstances and criteria for USADF to property as defined by law. suspend or terminate a collection Animal feeds, Food additives. action. Therefore, under the Federal Food, DATES: This final rule is effective Subpart F describes the circumstances Drug, and Cosmetic Act and under February 27, 2017. for USADF to discharge a delinquent authority delegated to the Commissioner FOR FURTHER INFORMATION CONTACT: June debt and reporting a discharge of debt of Food and Drugs and redelegated to B. Brown, 202–233–8882. to the Internal Revenue Service. the Center for Veterinary Medicine, 21 SUPPLEMENTARY INFORMATION: Subpart G addresses when USADF CFR part 573 is amended as follows: refers claims to the Department of I. Background Justice for litigation. PART 573—FOOD ADDITIVES In accordance with the requirements Subpart H addresses when USADF is PERMITTED IN FEED AND DRINKING of the DCIA and the implementing required to transfer debts to the WATER OF ANIMALS regulations promulgated by Justice and Financial Management Service of the Treasury at 31 CFR parts 900–904, Department of the Treasury. ■ 1. The authority citation for part 573 USADF is revising its regulations to continues to read as follows: III. Matters of Regulatory Procedure establish procedures for the asabaliauskas on DSK3SPTVN1PROD with RULES Authority: 21 U.S.C. 321, 342, 348. administrative collection, offset, Executive Order 12866 ■ 2. In § 573.696, revise the introductory compromise, suspension and The proposed regulations have been text and paragraph (b) to read as termination of collection activity for determined to be non-significant within follows: civil claims for money, funds, or the meaning of Executive Order 12866. property, as defined by 31 U.S.C. § 573.696 Feed grade sodium formate. 3701(b), and the process by which Regulatory Flexibility Act The food additive, feed grade sodium USADF can refer civil claims to The USADF President, in accordance formate, may be safely used in the Treasury, Treasury-designated debt with the Regulatory Flexibility Act, 5 VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00119 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1


Document Created: 2018-02-14 09:14:08
Document Modified: 2018-02-14 09:14:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective December 27, 2016. Submit either written or electronic objections and requests for a hearing by January 26, 2017. See section V of this document for information on the filing of objections.
ContactChelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation81 FR 95026 
CFR AssociatedAnimal Feeds and Food Additives
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