Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations 37037 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 573 

[Docket No. FDA–2019–F–5401] 

Food Additives Permitted in Feed and 

Drinking Water of Animals; 

Guanidinoacetic Acid 

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 guanidinoacetic acid as 

a precursor of creatine in poultry feeds. 

This action is in response to a food 

additive petition filed by Alzchem 

Trostberg GmbH. 

DATES: This rule is effective July 14, 

2021. See section V of this document for 

further information on the filing of 

objections. Submit either electronic or 

written objections and requests for a 

hearing on the final rule by August 13, 

2021. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. 

Electronic objections must be submitted 

on or before August 13, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of August 13, 2021. 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– 

2019–F–5401 for ‘‘Food Additives 

Permitted in Feed and Drinking Water 

of Animals; Guanidinoacetic Acid.’’ 

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: 

Carissa Adams, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl. 

(HFV–221), Rockville, MD 20855, 240– 

402–6283, Carissa.Adams@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a document published in the 

Federal Register of November 29, 2019 

(84 FR 65717), FDA announced that we 

had filed a food additive petition 

(animal use) (FAP 2309) submitted by 

Alzchem Trostberg GmbH, Dr.-AlbertFrank-Str. 32, 83308 Trostberg, 

Germany. 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 guanidinoacetic acid as a 

precursor of creatine in poultry feeds. 

II. Conclusion 

FDA concludes that the data establish 

the safety and utility of guanidinoacetic 

acid as a precursor of creatine in poultry 

feeds 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. 

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 


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37038 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations 

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, 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 § 573.496, revise the introductory 

text and paragraphs (b) and (e)(2)(i) to 

read as follows: 

§ 573.496 Guanidinoacetic acid. 

The food additive, guanidinoacetic 

acid, may be safely used in poultry 

feeds in accordance with the following 

prescribed conditions: 

* * * * * 

(b) The additive is used or intended 

for use at levels not to exceed 0.12 

percent of the complete feed: 

(1) To spare arginine in broiler 

chicken and turkey feeds; or 

(2) As a precursor of creatine in 

poultry feeds. 

* * * * * 

(e) * * * 

(2) * * * 

(i) A statement to indicate the 

maximum use level of guanidinoacetic 

acid must not exceed 0.12 percent of the 

complete feed for poultry; and 

* * * * * 

Dated: July 7, 2021. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

Dated: July 12, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–15070 Filed 7–13–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Part 1910 

[Docket No. OSHA–2020–0004] 

RIN 1218–AD36 

Occupational Exposure to COVID–19; 

Emergency Temporary Standard 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Department of 

Labor. 

ACTION: Interim final rule; correction. 

SUMMARY: OSHA is fixing minor errors 

in the interim final rule published on 

June 21, 2021, titled Occupational 

Exposure to COVID–19; Emergency 

Temporary Standard, including 

correcting the docket number for 

submission of comments related to 

OSHA’s information collection 

estimates under the Paperwork 

Reduction Act. 

DATES: Effective July 14, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Press inquiries: Frank Meilinger, 

Director, OSHA Office of 

Communications; telephone: (202) 693– 

1999; email: meilinger.francis2@dol.gov. 

For technical inquiries: Maureen 

Ruskin, OSHA Directorate of Standards 

and Guidance; telephone: (202) 693– 

1955; email: ruskin.maureen@dol.gov. 

SUPPLEMENTARY INFORMATION: 

I. Summary and Explanation 

On June 21, 2021, OSHA published an 

interim final rule establishing an 

emergency temporary standard (ETS) to 

protect healthcare and healthcare 

support service workers from 

occupational exposure to COVID–19 in 

settings where people with COVID–19 

are reasonably expected to be present 

(86 FR 32376). In the Dates section of 

the preamble, the agency inadvertently 

included an incorrect docket number for 

submitting comments related to the 

information collection estimates under 

the Paperwork Reduction Act. The 

agency is submitting this document to 

correct this error. 

In addition, in Section VI.B Economic 

Feasibility, several table references were 

incorrect or missing, some tables were 

incorrectly numbered, and one 

subsection heading was labeled 

incorrectly. Those changes are shown in 

the table below, titled ‘‘Table of Nonsubstantive Corrections.’’ 

II. Exemption From Notice-andComment Procedures 

OSHA has determined that these 

corrections are not subject to the 

procedures for public notice and 

comment specified in the 

Administrative Procedure Act (5 U.S.C. 

553) or Section 6(b) of the Occupational 

Safety and Health Act of 1970 (29 U.S.C. 

655(b)). This rulemaking only corrects 

minor errors in the published rule and 

does not affect or change any existing 

rights or obligations. No stakeholder is 

likely to object to these corrections. 

Therefore, the agency finds good cause 

that public notice and comment are 

unnecessary under 5 U.S.C. 553(b)(3)(B), 

29 U.S.C. 655(b), and 29 CFR 1911.5. 

III. Correction of Publication 

In FR Doc. 2021–12428 appearing in 

the Federal Register of June 21, 2021 

(86 FR 32376), make the following 

corrections in the DATES section of the 

preamble. 

On page 32376, in the second column, 

the second full paragraph is corrected to 

read as follows: 

Comments due: Written comments, 

including comments on any aspect of 

this ETS and whether this ETS should 

become a final rule, must be submitted 

by July 21, 2021 in Docket No. OSHA– 

2020–0004. Comments on the 

information collection determination 

described in Section VII.K of the 

preamble (OMB Review under the 

Paperwork Reduction Act of 1995) may 

be submitted by August 20, 2021 in 

Docket Number OSHA–2021–0003. 

In addition, the agency provides the 

following table, which contains a list of 

corrections of minor, non-substantive 

errors into section VI.B. These changes 

are to five table references within the 

text, six table numbers, and one 

subsection heading. 


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