Proposed Rule2023-13120
PHM Brands; Filing of Food Additive Petition
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by PHM Brands, proposing that the food additive regulation for chlorine dioxide be amended to provide for an additional method for producing the additive.
Full Text
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<title>Federal Register, Volume 88 Issue 118 (Wednesday, June 21, 2023)</title>
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[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Proposed Rules]
[Pages 40122-40123]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13120]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 88, No. 118 / Wednesday, June 21, 2023 /
Proposed Rules
[[Page 40122]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. FDA-2023-F-2319]
PHM Brands; Filing of Food Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of petition.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by PHM Brands, proposing that
the food additive regulation for chlorine dioxide be amended to provide
for an additional method for producing the additive.
DATES: Either electronic or written comments on the petitioner's
environmental assessment must be submitted by July 21, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 21, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-F-2319 for ``PHM Brands; Filing of Food Additive Petition.''
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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.'' FDA 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Karen Hall, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-9195.
SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that
we have filed a food additive petition (FAP 2A4832), submitted by
Burdock Group Consultants on behalf of PHM Brands, 730 17th Street,
Denver, Colorado 80202. The petition proposes to amend the food
additive regulations in Sec. 173.300 (21 CFR 173.300; Chlorine
dioxide) to provide for production of the additive via an electrolytic
method from a brine solution containing chloride salts.
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 environmental assessment 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.
[[Page 40123]]
We will also place on public display, at the Dockets Management
Staff and at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, any amendments to, or
comments on, the petitioner's environmental assessment 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: June 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13120 Filed 6-20-23; 8:45 am]
BILLING CODE 4164-01-P
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