
[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.

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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 
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.

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    (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


