
[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Proposed Rules]
[Pages 9989-9990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05103]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-0969]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Spent Bleaching Clay

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking; amendment.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending a notice of petition announcing that the Canadian Oilseed 
Processors Association has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of spent 
bleaching clay as a flow agent in canola meal for all livestock and 
poultry species. Additionally, the petition proposes that the 
regulations be amended to provide for the safe use of silicon dioxide 
and diatomaceous earth for use as components of spent bleaching clay. 
This petition included a request for categorical exclusion, but after 
review we determined the petitioner should prepare an environmental 
assessment (EA). The petitioner has prepared and submitted an EA, which 
at this time is being placed in the docket for public review and 
comment.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by April 18, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 18, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 18, 2019. Comments 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 comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
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 comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment 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 comments submitted to the Dockets 
Management Staff, FDA will post your comment, as

[[Page 9990]]

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-0969 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Spent Bleaching Clay.'' Received comments, 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 a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two 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 comments. 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 comments 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 comments 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, (HFV-224), 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6729, chelsea.trull@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), notice was given in the 
Federal Register of April 18, 2017 (82 FR 18268), that a food additive 
petition (FAP 2299) has been filed by the Canadian Oilseed Processors 
Association, 404-167 Lombard Ave., Winnipeg MB R3B 0T6, Canada. The 
petition proposes to amend Title 21 of the Code of Federal Regulations 
(CFR) in part 573 Food Additives Permitted in Feed and Drinking Water 
of Animals (21 CFR part 573) to provide for the safe use of spent 
bleaching clay as a flow agent in canola meal for all livestock and 
poultry species. Additionally, the submission proposes that the 
existing regulations be amended to provide for the safe use of silicon 
dioxide (21 CFR 573.940) and diatomaceous earth (21 CFR 573.340) for 
use as components of spent bleaching clay.
    This petition included a request for categorical exclusion, but 
after review we determined the proposed action on spent bleaching clay 
does not meet the criteria for a categorical exclusion under 21 CFR 
25.32(r). The petitioner has prepared and submitted an EA.
    We are reviewing the potential environmental impact of this 
petition. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
we are placing the EA submitted with the petition that is the subject 
of this notice on public display at the Dockets Management Staff (see 
DATES and ADDRESSES) for public review and comment.
    We will also place on public display, at the Dockets Management 
Staff and at https://www.regulations.gov, any amendments to, or 
comments on, the petitioner's EA without further announcement in the 
Federal Register. If, based on our review, we find that an 
environmental impact statement is not required, and this petition 
results in a regulation, we will publish the notice of availability of 
our finding of no significant impact and the evidence supporting that 
finding with the regulation in the Federal Register in accordance with 
21 CFR 25.51(b).

    Dated: March 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05103 Filed 3-18-19; 8:45 am]
 BILLING CODE 4164-01-P


