Rule2022-16566
Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase
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
August 3, 2022
Effective
August 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 fumonisin esterase to degrade fumonisins present in swine feed. This action is in response to a food additive petition filed by Biomin GmbH.
Full Text
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<title>Federal Register, Volume 87 Issue 148 (Wednesday, August 3, 2022)</title>
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[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Rules and Regulations]
[Pages 47343-47344]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16566]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2020-F-1275]
Food Additives Permitted in Feed and Drinking Water of Animals;
Fumonisin Esterase
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 fumonisin
esterase to degrade fumonisins present in swine feed. This action is in
response to a food additive petition filed by Biomin GmbH.
DATES: This rule is effective August 3, 2022. See section V of this
document for further information on the filing of objections. Either
electronic or written objections and requests for a hearing on the
final rule must be submitted by September 2, 2022.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections 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
September 2, 2022. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting objections. Objections 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<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 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-2020-F-1275 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Fumonisin Esterase.'' 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 <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.
<bullet> 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 copies in 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 <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 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: <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 objections 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: Wasima Wahid, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-221),
Rockville, MD 20855, 240-402-5857, <a href="/cdn-cgi/l/email-protection#5f283e2c36323e71283e37363b1f393b3e7137372c71383029"><span class="__cf_email__" data-cfemail="e49385978d8985ca93858c8d80a4828085ca8c8c97ca838b92">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of May 6, 2020 (85
FR 26902), FDA announced that we had filed a food additive petition
(animal use) (FAP 2311) submitted by Biomin GmbH, Erber Campus 1, 3131
Getzersdorf, Austria. 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 fumonisin esterase to degrade
fumonisins present in swine feed.
II. Conclusion
FDA concludes that the data establish the safety and utility of
fumonisin esterase to degrade fumonisins in swine feed, and that the
food additive regulations should be amended as set forth in this
document.
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 public disclosure (see
FOR FURTHER INFORMATION CONTACT). As provided in
[[Page 47344]]
Sec. 571.1(h), we will delete from the documents any materials that
are not available for public disclosure.
IV. Analysis of Environmental Impact
We have 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
Any person who will be adversely affected by this regulation may
file with the Dockets Management Staff (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
shall constitute a waiver of the right to a hearing on the objection.
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. Add Sec. 573.485 to subpart B to read as follows:
Sec. 573.485 Fumonisin esterase.
The food additive fumonisin esterase may be safely used to degrade
fumonisins in swine feed in accordance with the following prescribed
conditions:
(a) Fumonisin esterase, a carboxylesterase, is produced by a
nontoxigenic and nonpathogenic yeast, Komagataella phaffii, genetically
engineered to express the fumonisin esterase gene from the bacterium
Sphingopyxis sp. Hydrolyzed fumonisin and two tricarballylic acid
molecules are the reaction products of fumonisin hydrolysis by this 493
amino acid fumonisin esterase enzyme.
(b) The additive shall meet the following specifications:
(1) The fermentation media for the Komagataella phaffii shall not
contain methanol.
(2) Viable genetically engineered Komagataella phaffii shall not be
present.
(3) One unit of fumonisin esterase activity is defined as the
amount of enzymatic activity required to release one micromole of
tricarballylic acid (CAS 99-14-9) per minute from 100 micromolar
fumonisin B1 in 20 millimolar Tris-hydrochloride buffer (pH 8.0)
containing 0.1 milligram per milliliter of bovine serum albumin at 30
[deg]C.
(c) The additive is incorporated at a minimum of 15 units of
fumonisin esterase activity per kilogram of complete swine feed that
cannot contain more than 10 parts per million of total fumonisins.
(d) To assure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act:
(1) The label and labeling of the additive, any feed premix, and
complete feed shall contain the common or usual name of the additive's
source, dried Komagataella phaffii fermentation product.
(2) The label and labeling of the additive and any feed premix
shall also contain:
(i) Adequate directions for use including a statement that the
additive must be uniformly applied and thoroughly mixed into complete
feeds;
(ii) A guarantee for the minimum amount of fumonisin esterase
activity, expressed in accordance with paragraph (b)(3) of this
section, and the unit of weight being consistent with the inclusion
rate stated in the directions for use;
(iii) Appropriate warning and safety precaution statements
concerning the additive as a respiratory sensitizer;
(iv) A cautionary statement concerning the maximum fumonisin
content as established in paragraph (c) of this section.
Dated: July 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16566 Filed 8-2-22; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on August 3, 2022.
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