[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Rules and Regulations]
[Pages 8929-8930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04275]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2017-F-5528]
Food Additives Permitted in Feed and Drinking Water of Animals;
Silicon Dioxide as a Carrier for Flavors
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 silicon
dioxide as a carrier for flavors for use in animal feed. This action is
in response to a food additive petition filed by Idemitsu Kosan, Cp.
Ltd.
DATES: This rule is effective March 2, 2018. See section V of this
document for information on the filing of objections. Submit either
electronic or written objections and requests for a hearing on the
final rule by April 2, 2018.
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 April
2, 2018. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of April 2,
2018. 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 comments. 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-2017-F-5528 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Silicon Dioxide as a Carrier for Flavors for Use in
Animal Feed.'' 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.
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
[[Page 8930]]
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
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224),
Rockville, MD 20855, 240-402-6729, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of September 25, 2017
(82 FR 44542), FDA announced that we had filed a food additive petition
(animal use) (FAP 2304) submitted by Idemitsu Kosan, Cp. Ltd., Agri-Bio
Business Dept., 1--1 Marunouchi 3-Chome, Chiyoda-Ku, Tokyo 1000-8321,
Japan. 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 silicon dioxide as a carrier for flavors for use in
animal feed.
II. Conclusion
FDA concludes that the data establish the safety and utility of
silicon dioxide as a carrier for flavors for use in animal feed and
that the food additive regulations should be amended as set forth in
this document. This is not a significant regulatory action subject to
Executive Order 12866.
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 inspection at the
Center for Veterinary Medicine by appointment with the information
contact person (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
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://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, 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. [thinsp]573.940, add paragraphs (d) and (e) to read as
follows:
Sec. 573.940 Silicon dioxide.
* * * * *
(d) It is used or intended for use in feed components, as a carrier
as follows:
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Limitations
Feed component (percent)
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Flavors................................................ 50
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(e) To ensure safe use of the additive, silicon dioxide is to be
used in an amount not to exceed that reasonably required to accomplish
its intended effect, and silicon dioxide from all sources cannot exceed
2 percent by weight of the complete feed.
Dated: February 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04275 Filed 3-1-18; 8:45 am]
BILLING CODE 4164-01-P