81_FR_67343 81 FR 67153 - Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate

81 FR 67153 - 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 190 (September 30, 2016)

Page Range67153-67154
FR Document2016-23671

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 swine feeds. This action is in response to a food additive petition filed by BASF Corp.

Federal Register, Volume 81 Issue 190 (Friday, September 30, 2016) 
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67153-67154]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23671]


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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; 
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 swine feeds. This 
action is in response to a food additive petition filed by BASF Corp.

DATES: This rule is effective September 30, 2016. Submit either 
electronic or written objections and requests for a hearing by October 
31, 2016. See section V of this document for further 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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to http://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 http://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-2014-F-0988 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 http://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 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 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 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, 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.

[[Page 67154]]

    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.
    Elsewhere in this issue of the Federal Register, FDA is providing 
notice of BASF Corp.'s proposal that FDA amend the food additive 
regulations for formic acid and ammonium formate 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.

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 swine 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 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 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 http://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. Add Sec.  573.696 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 feeds in accordance with the 
following prescribed conditions:
    (a) The additive is manufactured by the reaction of 99 percent 
formic acid and 50 percent sodium hydroxide in water to produce a 
solution made up of at least 20.5 percent sodium salt of formic acid 
and not more than 61 percent formic acid.
    (b) The additive is used or intended for use as a feed acidifying 
agent, to lower the pH, in complete swine feeds at levels not to exceed 
1.2 percent of the complete feed.
    (c) To assure 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) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
label and labeling shall contain:
    (1) The name of the additive.
    (2) Adequate directions for use, including a statement that feed 
grade sodium formate must be uniformly applied and thoroughly mixed 
into complete feeds and that the complete feeds so treated shall be 
labeled as containing feed grade sodium formate.
    (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 assure safe use of the additive, in addition to the other 
information required by the act and paragraph (d) of this section, the 
label and labeling shall contain:
    (1) Appropriate warnings and safety precautions concerning feed 
grade sodium formate.
    (2) Statements identifying feed grade sodium formate as a corrosive 
and possible severe irritant.
    (3) Information about emergency aid in case of accidental exposure 
as follows:
    (i) Statements reflecting requirements of applicable sections of 
the Superfund Amendments and Reauthorization Act (SARA), and the 
Occupational Safety and Health Administration (OSHA) human safety 
guidance regulations.
    (ii) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Material Safety Data Sheet 
(MSDS).

    Dated: September 26, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-23671 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations 67153 ‘‘000986’’ wherever it appears and in its Electronic Submissions information you claim to be confidential place add ‘‘058198’’. Submit electronic objections in the with a heading or cover note that states following way: ‘‘THIS DOCUMENT CONTAINS § 558.366 [Amended] CONFIDENTIAL INFORMATION.’’ The • Federal eRulemaking Portal: http:// ■ 25. In § 558.366, in paragraph (d), in Agency will review this copy, including www.regulations.gov. Follow the the entry for ‘‘113.5 (0.0125 pct)’’, the claimed confidential information, in instructions for submitting comments. remove ‘‘000986’’ and in its place add its consideration of comments. The Objections submitted electronically, ‘‘058198’’. second copy, which will have the including attachments, to http:// § 558.618 [Amended] www.regulations.gov will be posted to claimed confidential information the docket unchanged. Because your redacted/blacked out, will be available ■ 26. In § 558.618, redesignate for public viewing and posted on http:// paragraphs (c) and (d) as paragraphs (d) objection will be made public, you are solely responsible for ensuring that your www.regulations.gov. Submit both and (c). copies to the Division of Dockets ■ 27. In § 558.633, revise paragraph objection does not include any confidential information that you or a Management. If you do not wish your (d)(1) to read as follows: name and contact information to be third party may not wish to be posted, § 558.633 Tylvalocin. such as medical information, your or made publicly available, you can anyone else’s Social Security number, or provide this information on the cover * * * * * confidential business information, such sheet and not in the body of your (d) * * * as a manufacturing process. Please note objections and you must identify this (1) Federal law restricts medicated that if you include your name, contact information as ‘‘confidential.’’ Any feed containing this veterinary feed information, or other information that information marked as ‘‘confidential’’ directive (VFD) drug to use by or on the identifies you in the body of your will not be disclosed except in order of a licensed veterinarian. See objection, that information will be accordance with 21 CFR 10.20 and other § 558.6 for additional requirements. posted on http://www.regulations.gov. applicable disclosure law. For more * * * * * information about FDA’s posting of • If you want to submit an objection Dated: September 21, 2016. with confidential information that you comments to public dockets, see 80 FR Tracey Forfa, do not wish to be made available to the 56469, September 18, 2015, or access Deputy Director, Center for Veterinary public, submit the objection as a the information at: http://www.fda.gov/ Medicine. written/paper submission and in the regulatoryinformation/dockets/ [FR Doc. 2016–23230 Filed 9–29–16; 8:45 am] manner detailed (see ‘‘Written/Paper default.htm. BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to read background documents or the Written/Paper Submissions electronic and written/paper objections DEPARTMENT OF HEALTH AND Submit written/paper submissions as received, go to http:// HUMAN SERVICES follows: www.regulations.gov and insert the • Mail/Hand delivery/Courier (for docket number, found in brackets in the Food and Drug Administration written/paper submissions): Division of heading of this document, into the Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts 21 CFR Part 573 and Drug Administration, 5630 Fishers and/or go to the Division of Dockets Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. [Docket No. FDA–2014–F–0988] • For written/paper objections 1061, Rockville, MD 20852. submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Food Additives Permitted in Feed and Management, FDA will post your Chelsea Trull, Center for Veterinary Drinking Water of Animals; Feed Grade objection, as well as any attachments, Medicine, Food and Drug Sodium Formate except for information submitted, Administration, 7519 Standish Pl., marked and identified, as confidential, Rockville, MD 20855, 240–402–6729, AGENCY: Food and Drug Administration, if submitted as detailed in chelsea.trull@fda.hhs.gov. HHS. ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: ACTION: Final rule. Instructions: All submissions received must include the Docket No. FDA– I. Background SUMMARY: The Food and Drug Administration (FDA, we, the Agency) 2014–F–0988 for ‘‘Food Additives In a document published in the is amending the regulations for food Permitted in Feed and Drinking Water Federal Register of July 25, 2014 (79 FR additives permitted in feed and drinking of Animals; Feed Grade Sodium 43325), FDA announced that we had water of animals to provide for the safe Formate.’’ Received objections will be filed a food additive petition (animal use of feed grade sodium formate as a placed in the docket and, except for use) (FAP 2286) submitted by BASF feed acidifying agent in complete swine those submitted as ‘‘Confidential Corp., 100 Park Ave., Florham Park, NJ feeds. This action is in response to a Submissions,’’ publicly viewable at 07932. The petition proposed that the food additive petition filed by BASF http://www.regulations.gov or at the regulations for food additives permitted Corp. Division of Dockets Management in feed and drinking water of animals be between 9 a.m. and 4 p.m., Monday amended to provide for the safe use of asabaliauskas on DSK3SPTVN1PROD with RULES DATES: This rule is effective September through Friday. feed grade sodium formate as a feed 30, 2016. Submit either electronic or • Confidential Submissions—To acidifying agent in complete swine written objections and requests for a submit an objection with confidential feeds. The notice of petition provided hearing by October 31, 2016. See section information that you do not wish to be for a 30-day comment period on the V of this document for further made publicly available, submit your petitioner’s request for categorical information on the filing of objections. objections only as a written/paper exclusion from preparing an ADDRESSES: You may submit objections submission. You should submit two environmental assessment or and requests for a hearing as follows: copies total. One copy will include the environmental impact statement. VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1

67154 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations In addition, the petition proposed that include a detailed description and complete feeds and that the complete the animal food additive regulations for analysis of the specific factual feeds so treated shall be labeled as formic acid and ammonium formate be information intended to be presented in containing feed grade sodium formate. amended to limit formic acid and support of the objection in the event (3) Cautions for use including this formate salts from all added sources to that a hearing is held. Failure to include statement: Caution: Follow label 1.2 percent of complete feeds. This such a description and analysis for any directions. Formic acid and formate element of the petition was not particular objection shall constitute a salts from all added sources cannot described in the July 2014 notice of waiver of the right to a hearing on the exceed 1.2 percent of complete feed petition. objection. when multiple sources of formic acid Elsewhere in this issue of the Federal Any objections received in response and its salts are used in combination. Register, FDA is providing notice of to the regulation may be seen in the (e) To assure safe use of the additive, BASF Corp.’s proposal that FDA amend Division of Dockets Management in addition to the other information the food additive regulations for formic between 9 a.m. and 4 p.m., Monday required by the act and paragraph (d) of acid and ammonium formate to limit through Friday, and will be posted to this section, the label and labeling shall formic acid and formate salts from all the docket at http:// contain: added sources to 1.2 percent of www.regulations.gov. (1) Appropriate warnings and safety complete feed when multiple sources of precautions concerning feed grade List of Subjects in 21 CFR Part 573 sodium formate. formic acid and its salts are used in combination. Animal feeds, Food additives. (2) Statements identifying feed grade Therefore, under the Federal Food, sodium formate as a corrosive and II. Conclusion possible severe irritant. Drug, and Cosmetic Act and under FDA concludes that the data establish authority delegated to the Commissioner (3) Information about emergency aid the safety and utility of feed grade of Food and Drugs and redelegated to in case of accidental exposure as sodium formate for use as a feed the Center for Veterinary Medicine, 21 follows: acidifying agent in complete swine CFR part 573 is amended as follows: (i) Statements reflecting requirements feeds and that the food additive of applicable sections of the Superfund regulations should be amended as set PART 573—FOOD ADDITIVES Amendments and Reauthorization Act forth in this document. PERMITTED IN FEED AND DRINKING (SARA), and the Occupational Safety WATER OF ANIMALS and Health Administration (OSHA) III. Public Disclosure human safety guidance regulations. In accordance with § 571.1(h) (21 CFR ■ 1. The authority citation for part 573 (ii) Contact address and telephone 571.1(h)), the petition and documents continues to read as follows: number for reporting adverse reactions we considered and relied upon in Authority: 21 U.S.C. 321, 342, 348. or to request a copy of the Material reaching our decision to approve the ■ 2. Add § 573.696 to read as follows: Safety Data Sheet (MSDS). petition will be made available for Dated: September 26, 2016. public disclosure (see FOR FURTHER § 573.696 Feed grade sodium formate. Tracey H. Forfa, INFORMATION CONTACT). As provided in The food additive, feed grade sodium Deputy Director, Center for Veterinary § 571.1(h), we will delete from the formate, may be safely used in the Medicine. documents any materials that are not manufacture of complete swine feeds in [FR Doc. 2016–23671 Filed 9–29–16; 8:45 am] available for public disclosure. accordance with the following BILLING CODE 4164–01–P prescribed conditions: IV. Analysis of Environmental Impact (a) The additive is manufactured by The Agency has determined under 21 the reaction of 99 percent formic acid DEPARTMENT OF HEALTH AND CFR 25.32(r) that this action is of a type and 50 percent sodium hydroxide in HUMAN SERVICES that does not individually or water to produce a solution made up of cumulatively have a significant effect on at least 20.5 percent sodium salt of Food and Drug Administration the human environment. Therefore, formic acid and not more than 61 neither an environmental assessment, percent formic acid. 21 CFR Part 882 nor an environmental impact statement (b) The additive is used or intended is required. [Docket No. FDA 2016–N–2677] for use as a feed acidifying agent, to V. Objections and Hearing Requests lower the pH, in complete swine feeds Medical Devices; Neurological at levels not to exceed 1.2 percent of the Devices; Classification of the Evoked Any person who will be adversely complete feed. affected by this regulation may file with Photon Image Capture Device (c) To assure safe use of the additive, the Division of Dockets Management formic acid and formate salts from all AGENCY: Food and Drug Administration, (see ADDRESSES) either electronic or added sources cannot exceed 1.2 HHS. written objections. Each objection shall percent of complete feed when multiple ACTION: Final order. be separately numbered, and each sources of formic acid and its salts are numbered objection shall specify with used in combination. SUMMARY: The Food and Drug particularity the provision of the (d) To assure safe use of the additive, Administration (FDA) is classifying the regulation to which objection is made in addition to the other information Evoked Photon Image Capture Device asabaliauskas on DSK3SPTVN1PROD with RULES and the grounds for the objection. Each required by the Federal Food, Drug, and into class I (general controls). The numbered objection on which a hearing Cosmetic Act, the label and labeling Agency is classifying the device into is requested shall specifically so state. shall contain: class I (general controls) in order to Failure to request a hearing for any (1) The name of the additive. provide a reasonable assurance of safety particular objection shall constitute a (2) Adequate directions for use, and effectiveness of the device. waiver of the right to a hearing on that including a statement that feed grade DATES: This order is effective September objection. Each numbered objection for sodium formate must be uniformly 30, 2016. The classification was which a hearing is requested shall applied and thoroughly mixed into applicable on July 15, 2016. VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1


Document Created: 2018-02-09 13:34:13
Document Modified: 2018-02-09 13:34:13
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 September 30, 2016. Submit either electronic or written objections and requests for a hearing by October 31, 2016. See section V of this document for further 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 67153 
CFR AssociatedAnimal Feeds and Food Additives
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