[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, [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.
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]
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