Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate, 67153-67154 [2016-23671]

Download as PDF Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations ‘‘000986’’ wherever it appears and in its place add ‘‘058198’’. § 558.366 [Amended] 25. In § 558.366, in paragraph (d), in the entry for ‘‘113.5 (0.0125 pct)’’, remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 558.618 [Amended] 26. In § 558.618, redesignate paragraphs (c) and (d) as paragraphs (d) and (c). ■ 27. In § 558.633, revise paragraph (d)(1) to read as follows: ■ § 558.633 Tylvalocin. * * * * * (d) * * * (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. * * * * * Dated: September 21, 2016. Tracey Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–23230 Filed 9–29–16; 8:45 am] BILLING CODE 4164–01–P 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 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. 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. asabaliauskas on DSK3SPTVN1PROD with RULES SUMMARY: 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: DATES: VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 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 PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 67153 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. 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 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 § 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. asabaliauskas on DSK3SPTVN1PROD with RULES 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 VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 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 1. The authority citation for part 573 continues to read as follows: ■ Authority: 21 U.S.C. 321, 342, 348. ■ 2. Add § 573.696 to read as follows: § 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 PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA 2016–N–2677] Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective September 30, 2016. The classification was applicable on July 15, 2016. SUMMARY: E:\FR\FM\30SER1.SGM 30SER1

Agencies

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67153-67154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

-----------------------------------------------------------------------

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