Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase, 52681-52682 [2022-18539]

Download as PDF Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Rules and Regulations Section 41712, however, refers only to ‘‘practices.’’ 59 In the UDP Final Rule, we explained that our aviation consumer protection regulations are always directed to practices of an airline or ticket agent, rather than isolated acts of individual employees. We also explained that our enforcement efforts include a determination that the conduct in question reflects a practice or policy affecting multiple consumers, rather than an isolated incident.60 We concluded that ‘‘in general, the Department is of the view that proof of a practice in the aviation consumer protection context requires more than a single isolated incident. On the other hand, even a single incident may be indicative of a practice if it reflects company policy, practice, training, or lack of training.’’ 61 Effective Date This guidance is effective August 29, 2022. Issued on or about this 15th day of August, 2022, in Washington, DC. John E. Putnam, General Counsel, U.S. Department of Transportation. [FR Doc. 2022–18170 Filed 8–26–22; 8:45 am] BILLING CODE 4910–9X–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA–2021–F–0564] Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. 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 poultry khammond on DSKJM1Z7X2PROD with RULES SUMMARY: and deceptive practices of ticket agents selling air transportation. 59 49 U.S.C. 41712(a) (‘‘the Secretary may investigate and decide whether an air carrier, foreign air carrier, or ticket agent has been or is engaged in an unfair or deceptive practice or an unfair method of competition in air transportation or the sale of air transportation.’’) 60 See, e.g., DOT Order 2018–2–7 (finding that an airline’s failure to respond timely to a single complaint did not warrant enforcement action in the absence of evidence of a pattern or practice). 61 85 FR 78711. VerDate Sep<11>2014 16:03 Aug 26, 2022 Jkt 256001 feed. This action is in response to a food additive petition filed by Biomin Holding GmbH. DATES: This rule is effective August 29, 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 28, 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 28, 2022. Objections 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 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 52681 identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2021–F–0564 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, 240–402–7500. • 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-201509-18/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. E:\FR\FM\29AUR1.SGM 29AUR1 52682 Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Rules and Regulations (HFV–221), Rockville, MD 20855, 240– 402–5857, wasima.wahid@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In a document published in the Federal Register of July 7, 2021 (86 FR 35806), FDA announced that we had filed a food additive petition (animal use) (FAP 2314) submitted by Biomin Holding GmbH, Biomin Research Center, Technopark 1, 3430 Tulin, 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 poultry feed. II. Conclusion FDA concludes that the data establish the safety and utility of fumonisin esterase to degrade fumonisins in poultry feed, and that the food additive regulations should be amended as set forth in this document. III. Public Disclosure In accordance with § 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 § 571.1(h), we will delete from the documents any materials that are not available for public disclosure. khammond on DSKJM1Z7X2PROD with RULES 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 VerDate Sep<11>2014 16:03 Aug 26, 2022 Jkt 256001 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. Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. 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 1. The authority citation for part 573 continues to read as follows: ■ Authority: 21 U.S.C. 321, 342, 348. 2. In § 573.485, revise the introductory text and paragraph (c) to read as follows: ■ § 573.485 Fumonisin esterase. The food additive fumonisin esterase may be safely used to degrade fumonisins in swine and poultry feed in accordance with the following prescribed conditions: * * * * * (c) The additive is incorporated at a minimum of 15 units of fumonisin esterase activity per kilogram of complete feed: (1) Complete swine feeds cannot contain more than 10 parts per million of total fumonisins. (2) Complete feed for poultry being raised for slaughter cannot contain more than 50 parts per million of total fumonisins. (3) Complete feed for breeding poultry and hens laying eggs for human consumption cannot contain more than 15 parts per million of total fumonisins. * * * * * Dated: August 24, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–18539 Filed 8–26–22; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2022–0647] RIN 1625–AA00 Safety Zone; Pacific Airshow, Huntington Beach, California Coast Guard, Department of Homeland Security (DHS). ACTION: Temporary final rule. AGENCY: The U.S. Coast Guard is establishing a safety zone offshore of Huntington Beach, CA, in support of the Pacific Airshow. This action is necessary to provide for the safety of life on these navigable waters in the area of the air and water demonstrations and to protect the high concentration of people attending the event. This regulation prohibits vessels from entering into, transiting through, or remaining within the designated area unless specifically authorized by the Captain of the Port, Sector Los Angeles—Long Beach (COTP), or a designated representative. DATES: This rule is effective from 7 a.m. on September 29, 2022, through 5 p.m. on October 2, 2022. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2022– 0647 in the search box and click ‘‘Search.’’ Next, in the Document Type column, select ‘‘Supporting & Related Material.’’ SUMMARY: If you have questions about this rule, call or email LCDR Maria Wiener, U.S. Coast Guard Sector Los Angeles—Long Beach; telephone (310) 521–3860, email D11SMB-SectorLALB-WWM@uscg.mil. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to E:\FR\FM\29AUR1.SGM 29AUR1

Agencies

[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Rules and Regulations]
[Pages 52681-52682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2021-F-0564]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Fumonisin Esterase

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 poultry feed. This action is 
in response to a food additive petition filed by Biomin Holding GmbH.

DATES: This rule is effective August 29, 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 28, 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 28, 2022. Objections 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 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-2021-F-0564 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, 240-
402-7500.
     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.

[[Page 52682]]

(HFV-221), Rockville, MD 20855, 240-402-5857, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of July 7, 2021 (86 
FR 35806), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2314) submitted by Biomin Holding GmbH, Biomin 
Research Center, Technopark 1, 3430 Tulin, 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 poultry feed.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
fumonisin esterase to degrade fumonisins in poultry 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 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.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov.

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. In Sec.  573.485, revise the introductory text and paragraph (c) to 
read as follows:


Sec.  573.485  Fumonisin esterase.

    The food additive fumonisin esterase may be safely used to degrade 
fumonisins in swine and poultry feed in accordance with the following 
prescribed conditions:
* * * * *
    (c) The additive is incorporated at a minimum of 15 units of 
fumonisin esterase activity per kilogram of complete feed:
    (1) Complete swine feeds cannot contain more than 10 parts per 
million of total fumonisins.
    (2) Complete feed for poultry being raised for slaughter cannot 
contain more than 50 parts per million of total fumonisins.
    (3) Complete feed for breeding poultry and hens laying eggs for 
human consumption cannot contain more than 15 parts per million of 
total fumonisins.
* * * * *

    Dated: August 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18539 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P
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