[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 [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting objections. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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 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 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 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 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 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: https://www.govinfo.gov/content/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 objections 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, 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, [email protected].

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


