[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:

------------------------------------------------------------------------
                                                           Limitations
                     Feed component                         (percent)
------------------------------------------------------------------------
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


