Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid, 86268-86270 [2016-28754]

Download as PDF sradovich on DSK3GMQ082PROD with RULES 86268 Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Rules and Regulations § 1026.3(b) exemption at consummation in year one is refinanced in year ten and that the new loan amount is less than the threshold amount in effect in year ten. In these circumstances, the creditor must comply with all of the applicable requirements of this part with respect to the year ten transaction if the original loan is satisfied and replaced by the new loan, which is not exempt under § 1026.3(b). See also comment 3(b)–6. 6. Addition of a security interest in real property or a dwelling after account opening or consummation. i. Open-end credit. For open-end accounts, if after account opening a security interest is taken in real property, or in personal property used or expected to be used as the consumer’s principal dwelling, a previously exempt account ceases to be exempt under § 1026.3(b) and the creditor must begin to comply with all of the applicable requirements of this part within a reasonable period of time. See comment 3(b)–4.ii. If a security interest is taken in the consumer’s principal dwelling, the creditor must also give the consumer the right to rescind the security interest consistent with § 1026.15. ii. Closed-end credit. For closed-end loans, if after consummation a security interest is taken in real property, or in personal property used or expected to be used as the consumer’s principal dwelling, an exempt loan remains exempt under § 1026.3(b). However, the addition of a security interest in the consumer’s principal dwelling is a transaction for purposes of § 1026.23, and the creditor must give the consumer the right to rescind the security interest consistent with that section. See § 1026.23(a)(1) and its commentary. In contrast, if a closed-end loan that is exempt under § 1026.3(b) is satisfied and replaced by a loan that is secured by real property, or by personal property used or expected to be used as the consumer’s principal dwelling, the new loan is not exempt under § 1026.3(b), and the creditor must comply with all of the applicable requirements of this part. See comment 3(b)–5. 7. Application to extensions secured by mobile homes. Because a mobile home can be a dwelling under § 1026.2(a)(19), the exemption in § 1026.3(b) does not apply to a credit extension secured by a mobile home that is used or expected to be used as the principal dwelling of the consumer. See comment 3(b)–6. 8. Transition rule for open-end accounts exempt prior to July 21, 2011. Section 1026.3(b)(2) applies only to open-end accounts opened prior to July 21, 2011. Section 1026.3(b)(2) does not apply if a security interest is taken by VerDate Sep<11>2014 16:13 Nov 29, 2016 Jkt 241001 the creditor in real property, or in personal property used or expected to be used as the consumer’s principal dwelling. If, on July 20, 2011, an openend account is exempt under § 1026.3(b) based on a firm commitment to extend credit in excess of $25,000, the account remains exempt under § 1026.3(b)(2) until December 31, 2011 (unless the firm commitment is reduced to $25,000 or less). If the firm commitment is increased on or before December 31, 2011 to an amount in excess of $50,000, the account remains exempt under § 1026.3(b)(1) regardless of subsequent increases in the threshold amount as a result of increases in the CPI–W. If the firm commitment is not increased on or before December 31, 2011 to an amount in excess of $50,000, the account ceases to be exempt under § 1026.3(b) based on a firm commitment to extend credit. For example: i. Assume that, on July 20, 2011, the account is exempt under § 1026.3(b) based on the creditor’s firm commitment to extend $30,000 in credit. On November 1, 2011, the creditor increases the firm commitment on the account to $55,000. In these circumstances, the account remains exempt under § 1026.3(b)(1) regardless of subsequent increases in the threshold amount as a result of increases in the CPI–W. ii. Same facts as paragraph i above except, on November 1, 2011, the creditor increases the firm commitment on the account to $40,000. In these circumstances, the account ceases to be exempt under § 1026.3(b)(2) after December 31, 2011, and the creditor must begin to comply with the applicable requirements of this part. * * * * * By order of the Board of Governors of the Federal Reserve System, November 17, 2016. Robert deV. Frierson, Secretary of the Board. Dated: November 7, 2016. Richard Cordray, Director, Bureau of Consumer Financial Protection. [FR Doc. 2016–28718 Filed 11–29–16; 8:45 am] BILLING CODE 6210–01–4810–AM–P PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA–2015–F–2337] Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid 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 guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. This action is in response to a food additive petition filed by Alzchem AG. DATES: This rule is effective November 30, 2016. Submit either written or electronic objections and requests for a hearing by December 30, 2016. 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: SUMMARY: 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’’). E:\FR\FM\30NOR1.SGM 30NOR1 Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES 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–2337 for ‘‘Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid.’’ 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 in 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 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. VerDate Sep<11>2014 16:13 Nov 29, 2016 Jkt 241001 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 16, 2015 (80 FR 42069), FDA announced that we had filed a food additive petition (animal use) (FAP 2292) submitted by Alzchem AG, Chemiepark Trostberg, Dr.-AlbertFrank-Str. 32, 83308, Trostberg, Germany. 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 guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey 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. 86269 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. II. Conclusion FDA concludes that the data establish the safety and utility of guanidinoacetic acid for use as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds and that the food additive regulations should be amended as set forth in this document. List of Subjects in 21 CFR Part 573 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 before making the documents available for inspection. PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 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: 1. The authority citation for part 573 continues to read as follows: ■ Authority: 21 U.S.C. 321, 342, 348. ■ 2. Add § 573.496 to read as follows: § 573.496 Guanidinoacetic acid. The food additive, guanidinoacetic acid, may be safely used in broiler chicken and turkey feeds in accordance with the following prescribed conditions: (a) The additive is manufactured by reacting glycine with cyanamide in an aqueous solution. E:\FR\FM\30NOR1.SGM 30NOR1 86270 Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Rules and Regulations (b) The additive is used or intended for use to spare arginine and as a precursor of creatine in broiler chicken and turkey feeds at levels not to exceed 0.12 percent of the complete feed. (c) The additive consists of not less than 97 percent guanidinoacetic acid [N-(aminoiminomethyl)-glycine] (CAS 352–97–6) by weight. (d) The additive meets the following specifications: (1) Dicyandiamide not to exceed 0.5 percent; (2) Cyanamide not to exceed 0.01 percent; (3) Melamine not to exceed 15 parts per million (ppm); (4) Sum of ammeline, ammelide, and cyanuric acid not to exceed 35 ppm; and (5) Water not to exceed 1 percent. (e) To assure safe use of the additive in addition to the other information required by the Federal Food, Drug, and Cosmetic Act: (1) The label and labeling of the additive, any feed premix, and complete feed shall contain the name of the additive. (2) The label and labeling of the additive and any feed premix shall also contain: (i) A statement to indicate that the maximum use level of guanidinoacetic acid must not exceed 0.12 percent of the complete feed for broiler chickens and turkeys; and (ii) Adequate directions for use. Dated: November 22, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–28754 Filed 11–29–16; 8:45 am] BILLING CODE 4164–01–P POSTAL SERVICE 39 CFR Part 265 Production or Disclosure of Material or Information Postal Service. ACTION: Final rule. AGENCY: The Postal Service is amending its regulations concerning compliance with the Freedom of Information Act (FOIA) to implement the changes to the procedures for the disclosure of records and for engaging in dispute resolution required by the FOIA Improvement Act of 2016. As part of this process, the Postal Service is also restructuring the regulations setting forth its FOIA procedures, without substantive change, to make them easier for members of the public to understand and use. sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:13 Nov 29, 2016 Jkt 241001 These regulations are effective December 27, 2016. ADDRESSES: Questions or comments on this action are welcome. Mail or deliver written comments to: Michael Elston, Associate General Counsel and Chief Ethics & Compliance Officer, 475 L’Enfant Plaza SW., Room 6000, Washington, DC 20260–1135. FOR FURTHER INFORMATION CONTACT: Natalie A. Bonanno, Chief Counsel, Federal Compliance, natalie.a.bonanno@usps.gov, (202) 268– 2944. SUPPLEMENTARY INFORMATION: The Postal Service is amending 39 CFR part 265 to implement changes to the procedures for the disclosure of records and for engaging in dispute resolution under the Freedom of Information Act (FOIA), 5 U.S.C. 552, as required by the FOIA Improvement Act of 2016 (FOIAIA), Public Law 114–185 (June 30, 2016), 130 Stat. 538. Under section 3 of the FOIA Improvement Act (130 Stat. 544) agencies are required to make such changes not later than 180 days after its date of enactment. The Postal Service has accordingly prepared a revision of 39 CFR part 265 to implement the amendments to the FOIA contained in section 2 of the FOIAIA. These amendments relate to such matters as the availability of certain records for public inspection in an electronic format; the assessment of fees related to voluminous record requests; modifications to the exemptions from disclosure for certain records described in 5 U.S.C. 552(b); and addressing the role of the Office of Government Information Services (OGIS). In addition, the Postal Service is restructuring its FOIA response procedures, without substantive change to their underlying policy, with the objective of enhancing their usefulness and comprehensibility. In this regard, 39 CFR part 265 has been retitled and subdivided into three subparts, dealing separately with (1) the generally applicable procedures for the disclosure of records under FOIA; (2) special rules applicable to the disclosure of records in compliance with subpoenas and other court orders, in response to requests for records or testimony in other legal proceedings, or pursuant to requests directed to the Postal Inspection Service; and (3) the rules concerning the availability of specific categories of records that are not subject to mandatory disclosure in whole or in part. As reorganized and amended, 39 CFR part 265 is structured as follows: DATES: PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 Subpart A—Procedures for Disclosure of Records Under the Freedom of Information Act This subpart sets forth the procedural rules applicable to the submission and processing of FOIA requests, including how and to whom a request should be submitted, the responsibility for and the timing of a response, the nature and content of the response, the treatment of confidential commercial information obtained from a submitter outside the Postal Service that may be protected from disclosure, the procedure for making an administrative appeal of the Postal Service’s response to a request, and the fees that may apply to processing a request. This subpart is designed to carry forward the substantive content of former §§ 265.1– 265.5 and §§ 265.7–265.9 in a more accessible and useful format. 265.1 General Provisions This section has been retitled and revised to present a concise and accessible overview of the policies and functions implemented by this subpart. 265.2 Proactive Disclosure of Postal Service Records This section has been retitled and revised to ensure the continued availability of those records that must be made publicly available, or are appropriate for public disclosure, and to provide for the posting and indexing of records in an electronic format as required under the FOIAIA. 265.3 Procedure for Submitting a FOIA Request This section has been retitled and revised to explain the organization and functions of the Postal Service’s FOIA Requester Service Centers (RSCs), as well as the procedures to be followed in submitting a FOIA request. 265.4 Responsibility for Responding to Requests This section has been retitled and revised to clarify the functional responsibilities of the RSCs in responding to FOIA requests. 265.5 Timing of Responses to Requests This section has been retitled and revised to set out the timeframe applicable to the processing of requests, including special provisions for the multitrack processing of simple or complex requests, expedited processing where appropriate, the extension of time in unusual circumstances, and aggregation of requests. E:\FR\FM\30NOR1.SGM 30NOR1

Agencies

[Federal Register Volume 81, Number 230 (Wednesday, November 30, 2016)]
[Rules and Regulations]
[Pages 86268-86270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-2337]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Guanidinoacetic Acid

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 
guanidinoacetic acid as a substance that spares arginine and serves as 
a precursor of creatine in broiler chicken and turkey feeds. This 
action is in response to a food additive petition filed by Alzchem AG.

DATES: This rule is effective November 30, 2016. Submit either written 
or electronic objections and requests for a hearing by December 30, 
2016. 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: 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'').

[[Page 86269]]

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-2337 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Guanidinoacetic Acid.'' 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 in 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 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 16, 2015 
(80 FR 42069), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2292) submitted by Alzchem AG, Chemiepark Trostberg, 
Dr.-Albert-Frank-Str. 32, 83308, Trostberg, Germany. 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 
guanidinoacetic acid as a substance that spares arginine and serves as 
a precursor of creatine in broiler chicken and turkey 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.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
guanidinoacetic acid for use as a substance that spares arginine and 
serves as a precursor of creatine in broiler chicken and turkey 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 before making the documents available for inspection.

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.  573.496 to read as follows:


Sec.  573.496   Guanidinoacetic acid.

    The food additive, guanidinoacetic acid, may be safely used in 
broiler chicken and turkey feeds in accordance with the following 
prescribed conditions:
    (a) The additive is manufactured by reacting glycine with cyanamide 
in an aqueous solution.

[[Page 86270]]

    (b) The additive is used or intended for use to spare arginine and 
as a precursor of creatine in broiler chicken and turkey feeds at 
levels not to exceed 0.12 percent of the complete feed.
    (c) The additive consists of not less than 97 percent 
guanidinoacetic acid [N-(aminoiminomethyl)-glycine] (CAS 352-97-6) by 
weight.
    (d) The additive meets the following specifications:
    (1) Dicyandiamide not to exceed 0.5 percent;
    (2) Cyanamide not to exceed 0.01 percent;
    (3) Melamine not to exceed 15 parts per million (ppm);
    (4) Sum of ammeline, ammelide, and cyanuric acid not to exceed 35 
ppm; and
    (5) Water not to exceed 1 percent.
    (e) To assure safe use of the additive in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and 
complete feed shall contain the name of the additive.
    (2) The label and labeling of the additive and any feed premix 
shall also contain:
    (i) A statement to indicate that the maximum use level of 
guanidinoacetic acid must not exceed 0.12 percent of the complete feed 
for broiler chickens and turkeys; and
    (ii) Adequate directions for use.

    Dated: November 22, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-28754 Filed 11-29-16; 8:45 am]
BILLING CODE 4164-01-P