[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Rules and Regulations]
[Pages 37037-37038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15070]
[[Page 37037]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2019-F-5401]
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, or 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 precursor of creatine in poultry feeds. This
action is in response to a food additive petition filed by Alzchem
Trostberg GmbH.
DATES: This rule is effective July 14, 2021. See section V of this
document for further information on the filing of objections. Submit
either electronic or written objections and requests for a hearing on
the final rule by August 13, 2021.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before August
13, 2021. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of August 13,
2021. Objections received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting objections. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your objection, that information will be
posted on https://www.regulations.gov.
If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper objections submitted to the Dockets
Management Staff, 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-2019-F-5401 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Guanidinoacetic Acid.'' Received objections, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
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 https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper objections received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Carissa Adams, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-221),
Rockville, MD 20855, 240-402-6283, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of November 29,
2019 (84 FR 65717), FDA announced that we had filed a food additive
petition (animal use) (FAP 2309) submitted by Alzchem Trostberg GmbH,
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 precursor of creatine in poultry feeds.
II. Conclusion
FDA concludes that the data establish the safety and utility of
guanidinoacetic acid as a precursor of creatine in poultry feeds and
that the food additive regulations should be amended as set forth in
this document.
III. Public Disclosure
In accordance with Sec. 571.1(h) (21 CFR 571.1(h)), the petition
and 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
We have 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
[[Page 37038]]
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 Dockets Management Staff (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.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, 21 CFR part 573 is amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for part 573 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. In Sec. 573.496, revise the introductory text and paragraphs (b)
and (e)(2)(i) to read as follows:
Sec. 573.496 Guanidinoacetic acid.
The food additive, guanidinoacetic acid, may be safely used in
poultry feeds in accordance with the following prescribed conditions:
* * * * *
(b) The additive is used or intended for use at levels not to
exceed 0.12 percent of the complete feed:
(1) To spare arginine in broiler chicken and turkey feeds; or
(2) As a precursor of creatine in poultry feeds.
* * * * *
(e) * * *
(2) * * *
(i) A statement to indicate the maximum use level of
guanidinoacetic acid must not exceed 0.12 percent of the complete feed
for poultry; and
* * * * *
Dated: July 7, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
Dated: July 12, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-15070 Filed 7-13-21; 8:45 am]
BILLING CODE 4164-01-P