Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations 37035 

11The FTC has issued over 150 closing letters to 

companies making misleading U.S.-origin claims. 

Made in USA Workshop Report at 3 (June 2020). 

Companies only receive closing letters if they 

demonstrate to staff they will come into compliance 

with the FTC’s Enforcement Policy Statement on 

‘‘Made in the USA.’’ The staff’s workshop report 

explains ‘‘companies often produce substantiation 

for updated claims to the FTC staff, and then 

present a plan that includes training staff, updating 

online marketing materials (e.g., company websites 

and social media platforms), updating hardcopy 

marketing materials (e.g., product packaging, 

advertisements, tradeshow materials), and working 

with dealers, distributors, and third-party retailers 

to ensure downstream claims are in compliance.’’ 

Id. at 3 n.7. The FTC has also settled over 25 

enforcement actions, charging that companies 

refused to come into compliance or engaged in 

outright fraud. Id. 

12 I would note as well that seeking civil penalties 

for deceptive MUSA claims, as defined under the 

Commission’s Rule, could have adverse market 

effects. Excessive penalties, divorced from harm, 

can result in over-deterrence. Importantly, the costs 

associated with over-deterrence are likely to 

increase with the expansiveness of the definition of 

labelling. 

13AMG v. FTC, slip op No. 19–508 (Apr. 22, 

2021), https://www.supremecourt.gov/opinions/ 

20pdf/19-508_l6gn.pdf. 

14See Federal Trade Commission Improvements 

Act of 1980, Public Law 96–252, 94 Stat. 374 (1980) 

(reforming the ability of the FTC to promulgate 

rules by requiring a multi-step process with public 

comment and subject to Congressional review). This 

Act also authorized $255 million in funding for the 

Commission and was the first time since 1977 the 

agency was funded through the traditional funding 

process after the backlash from Congress over its 

rulemaking activities. See Kintner, Earl, et al., ‘‘The 

Effect of the Federal Trade Commission 

Improvements Act of 1980 on the FTC’s 

Rulemaking and Enforcement Authority,’’ 58 Wash. 

U. Law Rev. 847 (1980); see also J. Howard Beagles 

III and Timothy J. Muris, FTC Consumer Protection 

at 100: 1970s Redux or Protecting Markets to Protect 

Consumers?, 83 Geo. Wash. L. Rev. 2157 (2015) 

(describing the ‘‘disastrous failures’’ of the FTC in 

the 1970s and the 1980s from enforcement and 

regulatory overreach and quoting Jean Carper, The 

Backlash at the FTC, Wash. Post, C1 (Feb. 6, 1977) 

(describing the backlash from Congress at the FTC, 

after a period of intense rulemaking activity 

culminating in the agency’s being dubbed the 

‘‘National Nanny’’)); see also Alex Propes, Privacy 

and FTC Rulemaking: A Historical Context, IAB 

(Nov. 6, 2018) (discussing how the FTC’s 

rulemaking history could be influencing 

Congressional comfort with vesting the FTC with 

additional privacy authority), https://www.iab.com/ 

news/privacy-ftc-rulemaking-authority-a-historicalcontext/. 

15See Transcript: Oversight of the Federal Trade 

Commission: Strengthening Protections for 

Americans’ Privacy and Data Security (May 8, 

2019), available at: https://docs.house.gov/ 

meetings/IF/IF17/20190508/109415/HHRG-116- 

IF17-Transcript-20190508.pdf. At this Hearing, Rep. 

McMorris Rogers stated: ‘‘In various proposals, 

some groups have called for the FTC to have 

additional resources and authorities. I remain 

skeptical of Congress delegating broad authority to 

the FTC or any agency. However, we must be 

mindful of the complexities of this issue as well as 

the lessons learned from previous grants of 

rulemaking authority to the Commission.’’ 

Transcript at 8–9. Rep. Walden similarly stated: ‘‘it 

has been a few decades, but there was a time when 

the FTC, as we heard, was given broad rulemaking 

authority but stepped past the bounds of what 

Congress and the public supported. This required 

further congressional action and new restrictions on 

the Commission.’’ Transcript at 62. 

consumers can trust ‘‘Made in the USA’’ 

claims.11 My colleagues believe the 

Commission’s 80 year MUSA enforcement 

program was a failure and only a rule and the 

imposition of penalties will deter false 

MUSA claims. I believe administrative 

consents, which were an integral part of this 

program, can be an appropriate remedy to 

address deceptive MUSA claims, consistent 

with the views of bipartisan Commissions 

during the last 25 years. I support seeking 

monetary relief where appropriate but cannot 

support acting outside the constraints of our 

legislative authority.12

I fear as well this Commission’s desire to 

promulgate or utilize our regulatory authority 

in ways that exceed the boundaries of 

underlying statutes and corresponding 

Congressional intent will continue. The 

Supreme Court’s recent decision in AMG 13

has eliminated the FTC’s ability to seek 

equitable monetary relief under Section 13(b) 

of the FTC Act to compensate consumers. 

Thus, the temptation to test the limits of our 

remaining sources of authority is strong. I 

urge my colleagues to pause. Previous FTC 

forays into areas outside its jurisdictional 

authority have resulted in swift 

condemnation from the courts and 

Congress.14 Expansive interpretations of our 

rulemaking authority will not engender 

confidence among members of Congress who 

have in the past expressed qualms about the 

FTC’s history of frolics and detours.15

[FR Doc. 2021–14610 Filed 7–13–21; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 573 

[Docket No. FDA–2020–F–1289] 

Food Additives Permitted in Feed and 

Drinking Water of Animals; 

Selenomethionine Hydroxy Analogue 

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 selenomethionine 

hydroxy analogue as a source of 

selenium in feed for beef and dairy 

cattle. This action is in response to a 

food additive petition filed by Adisseo 

France S.A.S. 

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 objections 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– 

2020–F–1289 for ‘‘Food Additives 

Permitted in Feed and Drinking Water 


lotter on DSK11XQN23PROD with RULES1
37036 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations 

of Animals; Selenomethionine Hydroxy 

Analogue.’’ 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: 

Chelsea Cerrito, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl. 

(HFV–221), Rockville, MD 20855, 240– 

402–6729, chelsea.cerrito@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a document published in the 

Federal Register of May 11, 2020 (85 FR 

27692), FDA announced that we had 

filed a food additive petition (animal 

use) (FAP 2312) submitted by Adisseo 

France S.A.S.; Immeuble Antony Parc II, 

10 Place du Ge ́ne ́ral de Gaulle, 92160 

Antony, France. 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 selenomethionine hydroxy 

analogue as a source of selenium in feed 

for beef and dairy cattle. 

II. Conclusion 

FDA concludes that the data establish 

the safety and utility of 

selenomethionine hydroxy analogue as 

a source of selenium in feed for beef and 

dairy cattle 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 

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 § 573.920, revise paragraphs 

(a)(6), (h)(2) and (3) introductory text to 

read as follows: 

§ 573.920 Selenium. 

(a) * * * 

(6) Paragraphs (b) through (h) of this 

section provide the currently acceptable 

levels of selenium supplementation. 

* * * * * 

(h) * * * 

(2) Selenium, as selenomethionine 

hydroxy analogue, is added to feed as 

follows: 

(i) In complete feed for chickens, 

turkeys, swine, beef cattle, and dairy 

cattle at a level not to exceed 0.3 ppm. 

(ii) In feed supplements for limit 

feeding for beef cattle at a level not to 

exceed an intake of 3 milligrams per 

head per day. 

(iii) In salt-mineral mixtures for freechoice feeding for beef cattle up to 120 

parts per million in a mixture for freechoice feeding at a rate not to exceed an 

intake of 3 milligrams per head per day. 

(3) To assure safe use of the additive, 

in addition to the other information 

required by the Federal Food, Drug, and 

Cosmetic Act, the label and labeling of 

selenomethionine hydroxy analogue in 

its packaged form shall contain: 

* * * * * 

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. 2021–15072 Filed 7–13–21; 8:45 am] 

BILLING CODE 4164–01–P 


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