[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Proposed Rules]
[Pages 28898-28899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10035]


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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 as components of spent bleaching clay. At our 
request, a revised environmental assessment (EA) has been placed in the 
docket for public review and comment.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by June 15, 2020.

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 June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 15, 2020. 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 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

[[Page 28899]]

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.govinfo.gov/content/pkg/FR-02015-09-18/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 Cerrito, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224), 
Rockville, MD 20855, 240-402-6729, [email protected].

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.
    In a Federal Register notice published on March 19, 2019 (84 FR 
9989), an amendment was made to the petition to include an 
environmental assessment. Based on a review of that assessment, we have 
asked the petitioner to make revisions.
    To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
we are placing the revised EA submitted with FAP 2299 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: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10035 Filed 5-13-20; 8:45 am]
 BILLING CODE 4164-01-P